Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, dynamics hyperinflation, Computed Tomography scan, CT scan, Functional Respiratory Imaging, FRI, Roflumilast, PRO
Brief summary
In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging. In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4. The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component. Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
Interventions
RADIATIONHRCT scan
HRCT scan of thorax, at baseline and after 3 months
Placebo, once a day in the morning during 3 months
DRUGRoflumilast
Roflumilast, once a day in the morning during 3 months
Sponsors
FLUIDDA nv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient ≥ 30 years old * Written informed consent obtained * Patient with Body mass index (BMI) ≥ 20 * Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study * COPD patient with GOLD stages C and D * Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation * Patient with smoking history of at least 10 pack-years * Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1 * Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
Exclusion criteria
* Pregnant or lactating females * Patient with severe immunological diseases and/ or severe acute infectious diseases * Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1 * Patient with diagnosis of cancer (except basal cell carcinoma) * Patient with a history of depression associated with suicidal ideation or behaviour * Patient with moderate or severe hepatic impairment. * Patient with lactose intolerance * Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. * Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit * Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aerosol deposition concentrations | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Air trapping | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Internal Lobar Airflow Distribution | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Low Attenuation or Emphysema Score | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Blood Vessel Density | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Airway Wall Thickness | 3 months | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Airway volume (iVaw) | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Airway resistance (iRaw) | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
| Changes in Lobe volumes (iVlobes) | At baseline and after 3 months of treatment | By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body plethysmography | At baseline and after 3 months of treatment | Body plethysmography is a composite outcome measure consisting of the following parameters: * Residual Volume (RV) * TLC * FRC * Airway resistance (Raw) |
| Changes in Diffusion capacity | At baseline and after 3 months of treatment | Diffusion capacity is a composite outcome measure consisting of the following parameters: * carbon monoxide transfer factor (TCO) * Alveolar volume (VA) |
| Changes in 6MWT | At baseline and after 3 months of treatment | Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test |
| Changes in Patient Related Outcome (PRO) | At baseline and after 3 months of treatment | Patient Related Outcome is a composite outcome measure consisting of the following questionnaires: * Borg CR10 Scale: measure of the present dyspnea and leg fatigue before and after exercise * COPD assessment test (CAT): measure of the impact of COPD on your life * Saint George's Respiratory Questionnaire (SGRQ): measure health related quality of life and comfort |
| Changes in Spirometry | At baseline and after 3 months of treatment | Spirometry is a composite outcome measure consisting of the following parameters: * FEV1 * Peak Expiratory Flow (PEF) * Forced Vital Capacity (FVC) * Maximum Expiratory Flow at 50% of FVC (MEF 50) * Maximum Expiratory Flow at 25% of FVC (MEF 25) |
Countries
Belgium
Outcome results
None listed