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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo

• Registration Number: NCT01048333
• Lead Sponsor: AstraZeneca

Brief Summary

* 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-09-09
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-25
• Last Update Submitted: 2012-09-25
• Results First Posted: 2012-10-25
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formoterol, then Salmeterol, then Placebo	Formoterol	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
Formoterol, then Salmeterol, then Placebo	Salmeterol	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
Formoterol, then Salmeterol, then Placebo	Placebo	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
Salmeterol, then Palcebo, then Formoterol	Formoterol	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Salmeterol, then Palcebo, then Formoterol	Salmeterol	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Salmeterol, then Palcebo, then Formoterol	Placebo	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Placebo, then Formoterol, then Salmeterol	Formoterol	Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Placebo, then Formoterol, then Salmeterol	Salmeterol	Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Placebo, then Formoterol, then Salmeterol	Placebo	Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Formoterol, then Placebo, then Salmeterol	Formoterol	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Formoterol, then Placebo, then Salmeterol	Salmeterol	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Formoterol, then Placebo, then Salmeterol	Placebo	Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Salmeterol, then Formoterol, then Placebo	Formoterol	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
Salmeterol, then Formoterol, then Placebo	Placebo	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
Placebo, then Salmeterol, then Formoterol	Formoterol	Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Placebo, then Salmeterol, then Formoterol	Salmeterol	Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Placebo, then Salmeterol, then Formoterol	Placebo	Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Salmeterol, then Formoterol, then Placebo	Salmeterol	Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler

Primary Outcome Measures

Name	Time	Method
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose	Pre-dose and 5 minutes post-dose	FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1

Secondary Outcome Measures

Name	Time	Method
Adverse Events	At baseline and at each day of treatment	Number of participants with at least 1 AE.
Average FEV1 During the First 15 Minutes Post Dose	Pre dose and 15 minutes post dose	Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Average FEV1 During 120 Minutes Post Dose	Pre dose and 120 minutes post dose	Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1	Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose	Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden