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

NCT00859404 | Unknown Phase 2 DMC

• 1 other identifier: GRC 3886-201
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Mild to moderate persistent asthma

Outcome Measures

Primary Outcomes (1)

• Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1

  12 weeks

Secondary Outcomes (11)

• 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

Study Arms (4)

1. oglemilast

EXPERIMENTAL

Drug: oglemilast

2. oglemilast

EXPERIMENTAL

Drug: oglemilast

3. oglemilast

EXPERIMENTAL

Drug: oglemilast

4. placebo

PLACEBO COMPARATOR

Drug: oglemilast

Interventions

oglemilast DRUG

Tablet oglemilast or placebo once a day, for 12 weeks

1. oglemilast; 2. oglemilast; 3. oglemilast; 4. placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

Glenmark investigational sites (28)

Mumbai, Bangalore Etc, India

Location

MeSH Terms

Conditions

Asthma

Interventions

oglemilast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 24, 2009

Record last verified: 2009-09

Locations

IN (1)