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

Glenmark Pharmaceuticals Europe Ltd. (R&D)282 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

282

Conditions

Asthma

Interventions

oglemilastDRUG

Tablet oglemilast or placebo once a day, for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Glenmark investigational sites (28)

Mumbai, Bangalore Etc, India

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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%)

Time frame: days 8, 36 and 64

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Frequency and severity of asthma exacerbations

Time frame: 12 weeks

Investigator global impression of change from baseline to day 85

Time frame: 12 weeks

Patient global impression of change from baseline to day 85

Data from ClinicalTrials.gov

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