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

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.

• 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)

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • 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, Italy
    • Research Site
• Spain
  • Barcelona, Spain
    • Research Site
  • Madrid, Spain
    • Research Site
  • Malaga, Spain
    • Research Site
• Sweden
  • Goteborg, Sweden
    • Research Site
  • Linkoping, Sweden
    • Research Site
  • Lulea, Sweden
    • Research Site
  • Lund, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formoterol, then Salmeterol, then Placebo; Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler
Experimental: Salmeterol, then Palcebo, then Formoterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler
Experimental: Placebo, then Formoterol, then Salmeterol; Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler
Experimental: Formoterol, then Placebo, then Salmeterol; Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler
Experimental: Salmeterol, then Formoterol, then Placebo; Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler
Experimental: Placebo, then Salmeterol, then Formoterol; Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus	Drug: Formoterol; Formoterol Turbuhaler 9 μg and Placebo Diskus; Drug: Salmeterol; Salmeterol Diskus 50 μg and Placebo Turbuhaler; Drug: Placebo; Placebo Diskus and Placebo Turbuhaler

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Georgios Stratelis, AstraZeneca MC Sweden; Principal Investigator: Mario Cazzola, professor, Italy

Publications and helpful links

General Publications

• Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Oxis Turbuhaler; Onset of effect
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate; Formoterol Fumarate
• Other Study ID Numbers: D5127C00001