Clinical trial NCT00859404: A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma
Keywords: Mild to moderate persistent asthma
Lead sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1
timeFrame: Days 8, 36, 64
measure: 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%)
timeFrame: days 8, 36 and 64
measure: Change from baseline in morning and evening PEF (based on patient diary)
timeFrame: 12 weeks
measure: Change in asthma day time symptom score from baseline at day 85
timeFrame: 12 weeks
measure: Change in asthma night time symptom score from baseline at day 85
timeFrame: 12 weeks
measure: Change in number of night time awakenings from baseline at day 85
timeFrame: 12 weeks
measure: Frequency and the use of rescue (reliever) medication (salbutamol)
timeFrame: 12 weeks
measure: Frequency and severity of asthma exacerbations
timeFrame: 12 weeks
measure: Investigator global impression of change from baseline to day 85
timeFrame: 12 weeks
measure: Patient global impression of change from baseline to day 85
timeFrame: 12 weeks
measure: Pharmacokinetic parameters of oglemilast
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mumbai, Bangalore etc
country: India
facility: Glenmark investigational sites (28)
Study officials:
References: