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

Primary Purpose

Asthma

Status

Unknown status

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

oglemilast

About this trial

This is an interventional treatment trial for Asthma focused on measuring Mild to moderate persistent asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Glenmark investigational sites (28)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

1. oglemilast

2. oglemilast

3. oglemilast

4. placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1

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%)

Change from baseline in morning and evening PEF (based on patient diary)

Change in asthma day time symptom score from baseline at day 85

Change in asthma night time symptom score from baseline at day 85

Change in number of night time awakenings from baseline at day 85

Frequency and the use of rescue (reliever) medication (salbutamol)

Frequency and severity of asthma exacerbations

Investigator global impression of change from baseline to day 85

Patient global impression of change from baseline to day 85

Pharmacokinetic parameters of oglemilast

Full Information

NCT ID

NCT00859404

First Posted

March 10, 2009

Last Updated

September 23, 2009

Sponsor

Glenmark Pharmaceuticals Europe Ltd. (R&D)

1. Study Identification

Unique Protocol Identification Number

NCT00859404

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Glenmark Pharmaceuticals Europe Ltd. (R&D)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Mild to moderate persistent asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1. oglemilast

Arm Type

Experimental

Arm Title

2. oglemilast

Arm Type

Experimental

Arm Title

3. oglemilast

Arm Type

Experimental

Arm Title

4. placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

oglemilast

Intervention Description

Tablet oglemilast or placebo once a day, for 12 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1

Time Frame

Days 8, 36, 64

Title

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

Title

Change from baseline in morning and evening PEF (based on patient diary)

Time Frame

12 weeks

Title

Change in asthma day time symptom score from baseline at day 85

Time Frame

12 weeks

Title

Change in asthma night time symptom score from baseline at day 85

Time Frame

12 weeks

Title

Change in number of night time awakenings from baseline at day 85

Time Frame

12 weeks

Title

Frequency and the use of rescue (reliever) medication (salbutamol)

Time Frame

12 weeks

Title

Frequency and severity of asthma exacerbations

Time Frame

12 weeks

Title

Investigator global impression of change from baseline to day 85

Time Frame

12 weeks

Title

Patient global impression of change from baseline to day 85

Time Frame

12 weeks

Title

Pharmacokinetic parameters of oglemilast

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Glenmark investigational sites (28)

City

Mumbai, Bangalore etc

Country

India

12. IPD Sharing Statement

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

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