Overview

This trial is active, not recruiting.

Condition asthma
Treatment oglemilast
Phase phase 2
Sponsor Glenmark Pharmaceuticals Europe Ltd. (R&D)
Start date October 2008
End date December 2009
Trial size 282 participants
Trial identifier NCT00859404, GRC 3886-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
(Experimental)
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
(Experimental)
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
(Placebo Comparator)
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks

Primary Outcomes

Measure
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1
time frame: 12 weeks

Secondary Outcomes

Measure
Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1
time frame: 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%)
time frame: days 8, 36 and 64
Change from baseline in morning and evening PEF (based on patient diary)
time frame: 12 weeks
Change in asthma day time symptom score from baseline at day 85
time frame: 12 weeks
Change in asthma night time symptom score from baseline at day 85
time frame: 12 weeks
Change in number of night time awakenings from baseline at day 85
time frame: 12 weeks
Frequency and the use of rescue (reliever) medication (salbutamol)
time frame: 12 weeks
Frequency and severity of asthma exacerbations
time frame: 12 weeks
Investigator global impression of change from baseline to day 85
time frame: 12 weeks
Patient global impression of change from baseline to day 85
time frame: 12 weeks
Pharmacokinetic parameters of oglemilast
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Glenmark Pharmaceuticals Europe Ltd. (R&D).