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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00859404
• Other study ID #: GRC 3886-201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 10, 2009
• Last updated: September 23, 2009
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2009
• Source: Glenmark Pharmaceuticals Europe Ltd. (R&D)
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 282
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks

Locations

Country	Name	City	State
India	Glenmark investigational sites (28)	Mumbai, Bangalore etc

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Europe Ltd. (R&D)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1		12 weeks	No
Secondary	Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1		Days 8, 36, 64	No
Secondary	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	No
Secondary	Change from baseline in morning and evening PEF (based on patient diary)		12 weeks	No
Secondary	Change in asthma day time symptom score from baseline at day 85		12 weeks	No
Secondary	Change in asthma night time symptom score from baseline at day 85		12 weeks	No
Secondary	Change in number of night time awakenings from baseline at day 85		12 weeks	No
Secondary	Frequency and the use of rescue (reliever) medication (salbutamol)		12 weeks	No
Secondary	Frequency and severity of asthma exacerbations		12 weeks	No
Secondary	Investigator global impression of change from baseline to day 85		12 weeks	Yes
Secondary	Patient global impression of change from baseline to day 85		12 weeks	Yes
Secondary	Pharmacokinetic parameters of oglemilast		12 weeks	No