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

Study Overview
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Brief Summary
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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)

Official Title
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A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Formoterol
* Drug: Salmeterol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formoterol, then Salmeterol, then Placebo<br>Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|
| Experimental: Salmeterol, then Palcebo, then Formoterol<br>Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|
| Experimental: Placebo, then Formoterol, then Salmeterol<br>Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|
| Experimental: Formoterol, then Placebo, then Salmeterol<br>Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|
| Experimental: Salmeterol, then Formoterol, then Placebo<br>Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|
| Experimental: Placebo, then Salmeterol, then Formoterol<br>Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus | Drug: Formoterol<br>* Formoterol Turbuhaler 9 μg and Placebo Diskus<br>Drug: Salmeterol<br>* Salmeterol Diskus 50 μg and Placebo Turbuhaler<br>Drug: Placebo<br>* Placebo Diskus and Placebo Turbuhaler<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average FEV1 During the First 15 Minutes Post Dose | Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1 | Pre dose and 15 minutes post dose | 
| Average FEV1 During 120 Minutes Post Dose | Average FEV1 during 120 minutes post dose, change versus pre dose FEV1 | Pre dose and 120 minutes post dose | 
| Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1 | 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 | Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose | 
| Adverse Events | Number of participants with at least 1 AE. | At baseline and at each day of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Onset of effect, COPD, Oxis Turbuhaler