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

Glenmark Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Asthma

Treatments: Drug: oglemilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00859404

GRC 3886-201

Details and patient eligibility

About

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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

282 participants in 4 patient groups, including a placebo group

1. oglemilast

Experimental group

Treatment:

Drug: oglemilast

2. oglemilast

Experimental group

Treatment:

Drug: oglemilast

3. oglemilast

Experimental group

Treatment:

Drug: oglemilast

4. placebo

Placebo Comparator group

Treatment:

Drug: oglemilast