Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Salmeterol; Drug: Formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01048333

D5127C00001

Details and patient eligibility

About

• Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
• Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

Enrollment: 109 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
• A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
• Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.

Exclusion criteria

• A history and/or current diagnosis of asthma.
• Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
• A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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109 participants in 6 patient groups

Formoterol, then Salmeterol, then Placebo

Experimental group

Description:

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol

Salmeterol, then Palcebo, then Formoterol

Experimental group

Description:

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol

Placebo, then Formoterol, then Salmeterol

Experimental group

Description:

Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol

Formoterol, then Placebo, then Salmeterol

Experimental group

Description:

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol

Salmeterol, then Formoterol, then Placebo

Experimental group

Description:

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol

Placebo, then Salmeterol, then Formoterol

Experimental group

Description:

Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Treatment:

Drug: Salmeterol

Drug: Placebo

Drug: Formoterol