A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma - Full Text View

Sponsor:	Glenmark Pharmaceuticals Europe Ltd. (R&D)
Information provided by:	Glenmark Pharmaceuticals Europe Ltd. (R&D)
ClinicalTrials.gov Identifier:	NCT00859404

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: oglemilast	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):

Primary Outcome Measures:

Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1 [ Time Frame: Days 8, 36, 64 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from baseline in morning and evening PEF (based on patient diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in asthma day time symptom score from baseline at day 85 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in asthma night time symptom score from baseline at day 85 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change in number of night time awakenings from baseline at day 85 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Frequency and the use of rescue (reliever) medication (salbutamol) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Frequency and severity of asthma exacerbations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Investigator global impression of change from baseline to day 85 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Patient global impression of change from baseline to day 85 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetic parameters of oglemilast [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	282
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859404

Locations

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

Sponsors and Collaborators

Glenmark Pharmaceuticals Europe Ltd. (R&D)

More Information

No publications provided

Responsible Party:	Dr Narendra Maharaj, Glenmark Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:	NCT00859404 History of Changes
Other Study ID Numbers:	GRC 3886-201
Study First Received:	March 10, 2009
Last Updated:	September 23, 2009
Health Authority:	India: Drugs Controller General of India; India: Institutional Review Board

Keywords provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):

Mild to moderate persistent asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012