Asthma
Conditions
Keywords
Mild to moderate persistent asthma
Brief summary
The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
Interventions
DRUGoglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
Sponsors
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: * Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value). The following criteria must be met at the randomisation visit: * At least 80% compliance during the single-blind placebo run-in period * FEV1 between 60% and 85% of the predicted value * Without asthma exacerbation during the run-in period * Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer * Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in * Use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%) | days 8, 36 and 64 |
| Change from baseline in morning and evening PEF (based on patient diary) | 12 weeks |
| Change in asthma day time symptom score from baseline at day 85 | 12 weeks |
| Change in asthma night time symptom score from baseline at day 85 | 12 weeks |
| Change in number of night time awakenings from baseline at day 85 | 12 weeks |
| Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1 | Days 8, 36, 64 |
| Frequency and severity of asthma exacerbations | 12 weeks |
| Investigator global impression of change from baseline to day 85 | 12 weeks |
| Patient global impression of change from baseline to day 85 | 12 weeks |
| Pharmacokinetic parameters of oglemilast | 12 weeks |
| Frequency and the use of rescue (reliever) medication (salbutamol) | 12 weeks |
Countries
India
Outcome results
None listed