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

Phase 2

• Conditions: Asthma
• Interventions: Drug: oglemilast

• Registration Number: NCT00859404
• Lead Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24
• Primary Completion: 2009-12
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. oglemilast	oglemilast	-
3. oglemilast	oglemilast	-
4. placebo	oglemilast	-
2. oglemilast	oglemilast	-

Primary Outcome Measures

Name	Time	Method
Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Glenmark investigational sites (28); 🇮🇳 Mumbai, Bangalore etc, India