Asthma
Conditions
Brief summary
This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma.
Detailed description
This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic asthma. Approximately three investigative sites in Canada will participate in this study, with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or placebo as a single IV infusion.
Interventions
BIOLOGICALMEDI-528 9 mg/kg
MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion
OTHERPlacebo
Placebo administered as a single intravenous infusion
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female adults, age 18 through 65 years of age at the time of screening; * Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures; * Previously documented diagnosis of asthma of \> 1 year duration, based on episodic symptoms of airflow obstruction, at least partial reversibility of airflow obstruction, with alternative diagnoses (e.g., chronic obstructive pulmonary disease) ruled out; * AHR in the methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) ≤ 16 mg/mL (Crapo, 2000); * Have dual response of EAR, defined as a decrease in FEV1 ≥ 20% at 0 to 3 hours after inhalation, and LAR, defined as a decrease in FEV1 ≥ 15% 3 to 7 hours after inhalation, to inhaled allergen; * Asthma symptoms are adequately controlled on short-acting β2 agonists (e.g., albuterol) alone; * Have had no significant changes in regular asthma medications and no acute asthma exacerbations requiring corticosteroid rescue, hospitalization, or emergency department visits for at least 4 weeks prior to screening and up through the time of the first dose of study drug on Study Day 0. * Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug on Study Day 0, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom) and must agree to continue using such precautions through Study Day 126; * Able to complete the follow-up period through Study Day 126, as required by the protocol. * Willing to forego other forms of experimental treatment and study procedures during the study; and * Able to provide spirometric readings that meet American Thoracic Society (ATS) standards (ATS, 1995).
Exclusion criteria
* Receipt of MEDI-528 in any previous clinical study; * History of allergy or adverse reactions to any component of the MEDI-528 formulation; * Lung disease other than allergic asthma (e.g. chronic bronchitis); * Current use of any systemic or inhaled immunosuppressive drugs, including systemic and inhaled corticosteroids (topical corticosteroids are permitted), long-acting β2 agonists, leukotriene antagonists, cromolyn sodium, nedocromil sodium, theophylline or any inhaled or systemic medication for asthma other than short-acting β2 agonists, for at least 4 weeks prior to study drug administration on Study Day 0. * Current use of any β-adrenergic antagonist (e.g. propranolol). * Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period. * Acute illnesses or evidence of clinically significant active infection, such as fever ³ 38.0°C (100.5°F) at screening and through the time of the study drug administration on Study Day 0; * Current allergy-vaccination therapy (i.e., desensitization immunotherapy) with less than 3 months of stable maintenance doses prior to the baseline allergen inhalation challenge; * Receipt of any investigational drug therapy within 30 days or any biologic(s) within 5 half-lives of the agent prior to the first dose of study drug through Study Day 150; * Receipt of any therapy with a leukocyte-depleting agent unless recovery in white cell count has been documented before screening; * Pregnancy (sexually active females must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0); * Is a nursing mother at the time of study enrollment; * Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A; * History of significant systemic disease (e.g., cancer; infection; coronary artery disease or other cardiovascular disease; or hematological, renal, hepatic, endocrinologic, neurologic, rheumatologic, or gastrointestinal disease); * History of cancer other than nonmelanoma skin cancer or cervical carcinoma-in-situ that have been treated successfully with curative therapy; * History of primary immunodeficiency; * History of pancreatitis; * History of use of tobacco products within 2 years of baseline or history of smoking \>= 10 pack-years; * Elective surgery planned from the time of screening through Study Day 126; * Clinically significant abnormalities (other than asthma) upon physical examination prior to study drug administration on Study Day 0; * Clinically significant abnormality, as determined by the investigator, on 12-lead ECG or chest radiograph at the time of screening; * At the time of screening, any of the following abnormalities: aspartate transaminase (AST), alanine transaminase (ALT), or amylase \> 1.5 × above the upper limits of normal (ULN); or serum creatinine \> 1.3 × ULN; or any other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator (PI), are judged to be clinically significant; or * Evidence of any systemic disease or respiratory disease (other than asthma), any finding upon physical examination or history of any disease that, in the opinion of the PI or medical monitor, may compromise the safety of the patient in the study or confound the analysis of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7 | Day 7 | Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge. |
| Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28 | Day 28 | Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge. |
| Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56 | Day 56 | Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge. |
| Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7 | Day 7 | Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Observed Maximum Sputum Concentration (Tmax) | Days -21 to -7, 7, 28, and 56 | Tmax of MEDI-528 in sputum |
| Time to Observed Maximum Nasal Lavage Concentration (Tmax) | Days -6 to -1, 8, 29, and 57 | Tmax of MEDI-528 in nasal lavage |
| Observed Maximum Serum Concentration (Cmax) | Days 0, 6, 7, 27, 55, 84, and 126 | Cmax of MEDI-528 in serum |
| Observed Maximum Sputum Concentration (Cmax) | Days -21 to -7, 7, 28, and 56 | Cmax of MEDI-528 in sputum |
| Observed Maximum Nasal Lavage Concentration (Cmax) | Days -6 to -1, 8, 29, and 57 | Cmax of MEDI-528 in nasal lavage |
| Incidence of Adverse Events | Days 0 - 126 | Number of participants experiencing adverse events (includes both adverse events and serious adverse events) |
| Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | Days 0, 6, 7, 27, 55, 84, and 126 | AUC(0-infinity) of MEDI-528 in serum |
| Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | Days 0, 6, 7, 27, 55, 84, and 126 | AUC(ext) of MEDI-528 in serum |
| Terminal Phase Half-Life (T1/2) | Days 0, 6, 7, 27, 55, 84, and 126 | T1/2 of MEDI-528 in serum |
| Total Body Clearance (CL) | Days 0, 6, 7, 27, 55, 84, and 126 | CL of MEDI-528 in serum |
| Terminal Phase Volume of Distribution (Vz) | Days 0, 6, 7, 27, 55, 84, and 126 | Vz of MEDI-528 in serum |
| Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | Days 0, 6, 7, 27, 55, 84, and 126 | AUC(0-t) of MEDI-528 in serum |
| Incidence of Serious Adverse Events | Days 0 - 126 | Number of participants experiencing serious adverse events |
| Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | Days 0, 27, 55, 84, and 126 | Number of participants with ADA to MEDI-528 |
| Time to Observed Maximum Serum Concentration (Tmax) | Days 0, 6, 7, 27, 55, 84, and 126 | Tmax of MEDI-528 in serum |
Countries
Canada
Participant flow
Recruitment details
Thirty patients were entered into the study between 16Oct2006 and 15Aug2007 at 2 sites in Canada.
Pre-assignment details
Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive Web response system (IWRS). Patients who were randomized into the study but did not complete the second allergen challenge on Day 7 were replaced, unless the patient withdrew for safety reasons.
Participants by arm
| Arm | Count |
|---|---|
| PLACEBO | 15 |
| MEDI528 9 mg/kg MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | PARTICIPANT LEFT STDUY REGION | 1 | 0 |
Baseline characteristics
| Characteristic | PLACEBO | MEDI528 9 mg/kg | Total |
|---|---|---|---|
| Age Continuous | 30.5 Years STANDARD_DEVIATION 9.6 | 26.5 Years STANDARD_DEVIATION 7.8 | 28.5 Years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 15 | 12 / 15 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 |
Outcome results
Primary
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 28
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28 | 2.91 Percent | Standard Deviation 133.75 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28 | -13.09 Percent | Standard Deviation 175.27 |
p-value: 0.798Univariate 2-sample t-test
Primary
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 28
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28 | 29.93 Percent | Standard Deviation 46.646 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 28 | -16.95 Percent | Standard Deviation 123.256 |
p-value: 0.254Univariate 2-sample t-test
Primary
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 56
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56 | 40.36 Percent | Standard Deviation 45.123 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56 | 31.85 Percent | Standard Deviation 53.709 |
p-value: 0.677Univariate 2-sample t-test
Primary
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56
Change from baseline (percent reduction) in mean maximum decline of AUC of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 56
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56 | 41.75 Percent | Standard Deviation 65.49 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 56 | 51.91 Percent | Standard Deviation 98.49 |
p-value: 0.766Univariate 2-sample t-test
Primary
Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 7
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7 | 21.86 Percent | Standard Deviation 94.34 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on LAR After Inhaled Allergen Challenge at Day 7 | -14.47 Percent | Standard Deviation 82.43 |
p-value: 0.318Univariate 2-sample t-test
Primary
Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Time frame: Day 7
Population: All participants who were randomized into the study and completed the second allergen challenge on Day 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PLACEBO | Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7 | 21.26 Percent | Standard Deviation 69.288 |
| MEDI528 9 mg/kg | Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7 | -16.21 Percent | Standard Deviation 61.788 |
p-value: 0.168Univariate 2-sample t-test
Secondary
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | 6047.098 Nanogram times day per milliliter | Geometric Coefficient of Variation 134 |
Secondary
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized, received any MEDI-528, and had sputum samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | 4136.234 Nanogram times day per milliliter | Geometric Coefficient of Variation 61.9 |
Secondary
Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
AUC(0-infinity) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] | 6224.272 Microgram times day per milliliter | Geometric Coefficient of Variation 17 |
Secondary
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | 1332.408 Nanogram times day per milliliter | Geometric Coefficient of Variation 147.6 |
Secondary
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | 5744.821 Microgram times day per milliliter | Geometric Coefficient of Variation 14.8 |
Secondary
Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
AUC(0-t) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] | 2382.123 Nanogram times day per milliliter | Geometric Coefficient of Variation 84 |
Secondary
Incidence of Adverse Events
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Time frame: Days 0 - 126
Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLACEBO | Incidence of Adverse Events | 11 Participants |
| MEDI528 9 mg/kg | Incidence of Adverse Events | 12 Participants |
Secondary
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Number of participants with ADA to MEDI-528
Time frame: Days 0, 27, 55, 84, and 126
Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLACEBO | Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | 0 Participants |
| MEDI528 9 mg/kg | Incidence of Anti-drug Antibodies (ADA) to MEDI-528 | 0 Participants |
Secondary
Incidence of Serious Adverse Events
Number of participants experiencing serious adverse events
Time frame: Days 0 - 126
Population: All subjects who received at least one dose of investigational product (MEDI-528 or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PLACEBO | Incidence of Serious Adverse Events | 1 Participants |
| MEDI528 9 mg/kg | Incidence of Serious Adverse Events | 0 Participants |
Secondary
Observed Maximum Nasal Lavage Concentration (Cmax)
Cmax of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Observed Maximum Nasal Lavage Concentration (Cmax) | 79.406 Nanogram per milliliter | Geometric Coefficient of Variation 136.6 |
Secondary
Observed Maximum Serum Concentration (Cmax)
Cmax of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Observed Maximum Serum Concentration (Cmax) | 229.672 Microgram per milliliter | Geometric Coefficient of Variation 18.1 |
Secondary
Observed Maximum Sputum Concentration (Cmax)
Cmax of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Observed Maximum Sputum Concentration (Cmax) | 71.843 Nanogram per milliliter | Geometric Coefficient of Variation 78.7 |
Secondary
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized, received any MEDI-528, and had sputum samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | 25.919 Percent | Geometric Coefficient of Variation 81.3 |
Secondary
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | 6.441 Percent | Geometric Coefficient of Variation 59.3 |
Secondary
Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
AUC(ext) of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] | 18.848 Percent | Geometric Coefficient of Variation 178.3 |
Secondary
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized, received any MEDI-528, and had sputum samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Terminal Phase Half-Life (T1/2) | 31.933 Day | Geometric Coefficient of Variation 83.1 |
Secondary
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized, received any MEDI-528, and had nasal lavage samples obtained
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Terminal Phase Half-Life (T1/2) | 25.584 Day | Geometric Coefficient of Variation 69 |
Secondary
Terminal Phase Half-Life (T1/2)
T1/2 of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Terminal Phase Half-Life (T1/2) | 34.316 Day | Geometric Coefficient of Variation 20.8 |
Secondary
Terminal Phase Volume of Distribution (Vz)
Vz of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Terminal Phase Volume of Distribution (Vz) | 5.025 Liter | Geometric Coefficient of Variation 23.8 |
Secondary
Time to Observed Maximum Nasal Lavage Concentration (Tmax)
Tmax of MEDI-528 in nasal lavage
Time frame: Days -6 to -1, 8, 29, and 57
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Time to Observed Maximum Nasal Lavage Concentration (Tmax) | 10.319 Day | Geometric Coefficient of Variation 169.6 |
Secondary
Time to Observed Maximum Serum Concentration (Tmax)
Tmax of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Time to Observed Maximum Serum Concentration (Tmax) | 0.028 Day | Geometric Coefficient of Variation 20.4 |
Secondary
Time to Observed Maximum Sputum Concentration (Tmax)
Tmax of MEDI-528 in sputum
Time frame: Days -21 to -7, 7, 28, and 56
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Time to Observed Maximum Sputum Concentration (Tmax) | 9.276 Day | Geometric Coefficient of Variation 99 |
Secondary
Total Body Clearance (CL)
CL of MEDI-528 in serum
Time frame: Days 0, 6, 7, 27, 55, 84, and 126
Population: All participants who were randomized and received any MEDI-528
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MEDI528 9 mg/kg | Total Body Clearance (CL) | 0.101 Liter per day | Geometric Coefficient of Variation 26.7 |