Non-small Cell Lung Cancer, Squamous Lung Dysplasia
Conditions
Brief summary
This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer. SECONDARY OBJECTIVES: I. To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein \[CRP\], monocyte chemotactic protein-1 \[MCP-1\], myeloid progenitor inhibitory factor-1 \[MPIF-1\] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment. II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies. OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs \> 1). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. ARM II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray. After completion of study treatment, patients are followed within 30 days.
Interventions
OTHERplacebo
Given orally
DRUGinositol
Given orally
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria: * Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer * Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history * At least 6 months since prior surgery, adjuvant chemotherapy, or radiotherapy * No current evidence of lung cancer by CT scan * No non-calcified lung nodules ≥ 10 mm diameter on spiral CT scan unless cancer is ruled out by PET/CT scan or by biopsy * ECOG performance status 0-1 * Hemoglobin normal * Leukocyte count ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 1.5 times ULN * ALT and AST ≤ 1.5 times ULN * BUN ≤ 1.5 times ULN * Chloride ≤ 1.5 times ULN * Total CO\_2 ≤ 1.5 times ULN * Sodium ≤ 1.5 times ULN * Calcium ≤ 1.5 times ULN * Potassium ≤ 1.5 times ULN * Phosphorus ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min * Fasting blood glucose normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated \> 6 months ago * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Severe chronic obstructive pulmonary disease requiring supplemental oxygen * Uncontrolled hypertension * Psychiatric illness or social situation that would limit compliance with study requirements * No schizophrenia or bipolar disorder * No diabetes * No requirement for supplemental oxygen (continuous or intermittent) * SaO\_2 ≥ 90% on room air * No history of allergic reactions attributed to inositol * No history of allergies to any ingredient in the study agent or placebo * No other concurrent investigational agents * At least 7 days since prior anticoagulant use (e.g., coumadin or heparin) * More than 6 months since prior participation in another chemoprevention clinical trial * No prior pneumonectomy * No prior solid organ transplantation * No concurrent lithium, carbamazepine, or valproate * No concurrent use of other natural health products containing inositol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | From baseline up to 6 months | The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression. |
| Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | From baseline up to 6 months | The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray | From baseline up to 6 months | — |
| Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment | From baseline up to 6 months | The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions. |
| Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA | From baseline up to 6 months | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). |
| Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia | From baseline up to 6 months | — |
Countries
Canada, United States
Participant flow
Recruitment details
448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013.
Pre-assignment details
363 subjects were excluded from pre-assignment: 342 ineligible via bronchoscopy, 3 participant decision, 13 lab values out of range, 1 screening time line issue and 4 suspicious of cancer.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Myo-inositol) Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. | 44 |
| Arm B (Placebo) Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. | 41 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Arm B (Placebo) | Total | Arm A (Myo-inositol) |
|---|---|---|---|
| Age, Continuous | 58.0 years | 58.0 years | 58.5 years |
| Alcohol Intake 1 or fewer drinks per day | 11 participants | 38 participants | 27 participants |
| Alcohol Intake 2-3 drinks per day | 13 participants | 20 participants | 7 participants |
| Alcohol Intake 4 or more drinks per day | 4 participants | 5 participants | 1 participants |
| Alcohol Intake None | 13 participants | 22 participants | 9 participants |
| Body Mass Index, kg/m^2 | 26.0 kg/m^2 | 26.5 kg/m^2 | 27.2 kg/m^2 |
| Dysplastic Lesions Identified 1 Dysplastic lesion | 19 participants | 41 participants | 22 participants |
| Dysplastic Lesions Identified >1 Dysplastic lesions | 22 participants | 44 participants | 22 participants |
| Most Advanced Histology Mild dysplasia | 13 participants | 28 participants | 15 participants |
| Most Advanced Histology Moderate dysplasia | 22 participants | 50 participants | 28 participants |
| Most Advanced Histology Severe dysplasia | 6 participants | 7 participants | 1 participants |
| Mucosal Biopsies Obtained | 7.0 biopsies | 7.0 biopsies | 6.0 biopsies |
| Prior NSAID (nonsteroidal anti-inflammatory drugs) Use No | 29 participants | 57 participants | 28 participants |
| Prior NSAID (nonsteroidal anti-inflammatory drugs) Use Yes | 12 participants | 28 participants | 16 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 80 Participants | 42 Participants |
| Region of Enrollment Canada | 33 participants | 69 participants | 36 participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Male | 28 Participants | 62 Participants | 34 Participants |
| Smoking Status Current | 26 participants | 53 participants | 27 participants |
| Smoking Status Former | 15 participants | 32 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 44 | 32 / 41 |
| serious Total, serious adverse events | 1 / 44 | 0 / 41 |
Outcome results
Primary
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.
The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Complete response | 10.2 percentage of participants |
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Stable disease | 15.9 percentage of participants |
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Progressive disease | 12.5 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Complete response | 7.4 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Stable disease | 22.6 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | Progressive disease | 10.3 percentage of participants |
Comparison: Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.p-value: 0.3995% CI: [0.7, 3]Generalized estimating equation model
Primary
Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.
The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression.
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Complete response | 26.3 percentage of participants |
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Partial response | 10.5 percentage of participants |
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Stable disease | 15.8 percentage of participants |
| Arm A (Myo-inositol) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Progressive disease | 47.4 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Progressive disease | 33.3 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Complete response | 13.9 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Stable disease | 36.1 percentage of participants |
| Arm B (Placebo) | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | Partial response | 16.7 percentage of participants |
Secondary
Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray
Time frame: From baseline up to 6 months
Population: Data were not collected due to a study team decision not to analyze this endpoint.
Secondary
Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -66.96 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -54.32 ng/mL |
Comparison: Comparison of the median difference in biomarker CC-16 level between arms.p-value: 0.1Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA | -0.08 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA | -0.58 ng/mL |
Comparison: Comparison of the median difference in biomarker CC-16 level between arms.p-value: 0.35Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -121.47 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | 10.70 ng/mL |
Comparison: Comparison of the median difference in biomarker CC18 level between arms.p-value: 0.63Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA | 1.50 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA | -0.16 ng/mL |
Comparison: Comparison of the median difference in biomarker CC18 level between arms.p-value: 0.46Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -9.25 pg/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | 9.41 pg/mL |
Comparison: Comparison of the median difference in biomarker CCL-2 level between arms.p-value: 0.58Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA | 2.19 pg/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA | 9.08 pg/mL |
Comparison: Comparison of the median difference in biomarker CCL-2 level between arms.p-value: 0.74Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA | 161.18 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA | -74.11 ng/mL |
Comparison: Comparison of the median difference in biomarker CRP level between arms.p-value: 0.8Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -0.68 pg/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -0.27 pg/mL |
Comparison: Comparison of the median difference in biomarker IL-6 level between arms.p-value: 0.03Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA | 0.06 pg/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA | 0.01 pg/mL |
Comparison: Comparison of the median difference in biomarker IL-6 level between arms.p-value: 0.22Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -3.46 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -1.15 ng/mL |
Comparison: Comparison of the median difference in biomarker MPO level between arms.p-value: 0.06Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA | 0.20 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA | 0.09 ng/mL |
Comparison: Comparison of the median difference in biomarker MPO level between arms.p-value: 0.55Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA | 0.77 mmol/L |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA | 0.88 mmol/L |
Comparison: Comparison of the median difference in biomarker Nitrotyrosine level between arms.p-value: 0.91Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -12.39 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | 7.21 ng/mL |
Comparison: Comparison of the median difference in biomarker SFTPD level between arms.p-value: 0.22Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA | -0.28 ng/mL |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA | -0.22 ng/mL |
Comparison: Comparison of the median difference in biomarker SFTPD level between arms.p-value: 0.52Wilcoxon Rank-Sum
Secondary
Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)
The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Myo-inositol) | Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -0.25 umol/L |
| Arm B (Placebo) | Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | -0.56 umol/L |
Comparison: Comparison of the median difference in biomarker Total Glutathione level between arms.p-value: 0.06Wilcoxon Rank-Sum
Secondary
Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Myo-inositol) | Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia | -22.8 percentage of Ki67 expression level | Standard Deviation 105.3 |
| Arm B (Placebo) | Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia | -6.2 percentage of Ki67 expression level | Standard Deviation 98.7 |
Secondary
Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment
The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.
Time frame: From baseline up to 6 months
Population: The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Myo-inositol) | Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment | -53.5 percentage change in number of lesions | Standard Deviation 116.1 |
| Arm B (Placebo) | Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment | -50.0 percentage change in number of lesions | Standard Deviation 115.8 |