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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048333
• Other study ID #: D5127C00001
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2010
• Last updated: September 25, 2012
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 (ß2-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol
Formoterol Turbuhaler 9 µg and Placebo Diskus
• Salmeterol
Salmeterol Diskus 50 µg and Placebo Turbuhaler
• Placebo
Placebo Diskus and Placebo Turbuhaler

Locations

Country	Name	City	State
Italy	Research Site	Bussolengo
Italy	Research Site	Cassano Delle Murge
Italy	Research Site	Catanzaro
Italy	Research Site	Cava dei Tirreni
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Parma
Italy	Research Site	Pisa
Italy	Research Site	Prato
Italy	Research Site	Roma
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Sweden	Research Site	Goteborg
Sweden	Research Site	Linkoping
Sweden	Research Site	Lulea
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Italy,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse Events	Number of participants with at least 1 AE.	At baseline and at each day of treatment	No