A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma

Study Overview
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Brief Summary
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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.

Official Title
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A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Dose Range Finding Study to Evaluate the Efficacy of Oglemilast in the Treatment of Stable Mild to Moderate Persistent Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: oglemilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. oglemilast<br> | Drug: oglemilast<br>* Tablet oglemilast or placebo once a day, for 12 weeks<br>|
| Experimental: 2. oglemilast<br> | Drug: oglemilast<br>* Tablet oglemilast or placebo once a day, for 12 weeks<br>|
| Experimental: 3. oglemilast<br> | Drug: oglemilast<br>* Tablet oglemilast or placebo once a day, for 12 weeks<br>|
| Placebo Comparator: 4. placebo<br> | Drug: oglemilast<br>* Tablet oglemilast or placebo once a day, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1 |  | Days 8, 36, 64 | 
| 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 | 
| Frequency and the use of rescue (reliever) medication (salbutamol) |  | 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to moderate persistent asthma