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

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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: oglemilast

• Study Type: Interventional
• Enrollment (Anticipated): 282
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Mumbai, Bangalore etc, India
    • Glenmark investigational sites (28)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. oglemilast	Drug: oglemilast; Tablet oglemilast or placebo once a day, for 12 weeks
Experimental: 2. oglemilast	Drug: oglemilast; Tablet oglemilast or placebo once a day, for 12 weeks
Experimental: 3. oglemilast	Drug: oglemilast; Tablet oglemilast or placebo once a day, for 12 weeks
Placebo Comparator: 4. placebo	Drug: oglemilast; Tablet oglemilast or placebo once a day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 10, 2009
• First Posted (Estimate): March 11, 2009

Study Record Updates

• Last Update Posted (Estimate): September 24, 2009
• Last Update Submitted That Met QC Criteria: September 23, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Mild to moderate persistent asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GRC 3886-201