Clinical trial

Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma

Name

0476-386

Description

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Trial arms

Trial start

2008-05-01

Estimated PCD

2009-02-01

Trial end

2009-02-01

Status

Completed

Phase

Early phase I

Treatment

Comparator: mometasone

mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)

Arms:

Comparator: montelukast

montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)

Arms:

Comparator: placebo (unspecified)

Placebo (Placebo once-daily, for approximately 2 weeks)

Arms:

Size

134

Primary endpoint

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)

Baseline and 2 weeks

Eligibility criteria

Inclusion Criteria: * Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler * Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator Exclusion Criteria: * Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components * Has required an oral corticosteroid rescue for worsening asthma during the screening period

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ACTUAL'}}

Updated at

2024-05-10

1 organization

2 products

1 indication

Organization

Product

Indication

Product