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

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ClinicalTrials.gov Identifier: NCT01048333
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : October 25, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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)

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Formoterol Drug: Salmeterol Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose [ Time Frame: 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 :
  1. Average FEV1 During the First 15 Minutes Post Dose [ Time Frame: Pre dose and 15 minutes post dose ]
    Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1

  2. Average FEV1 During 120 Minutes Post Dose [ Time Frame: Pre dose and 120 minutes post dose ]
    Average FEV1 during 120 minutes post dose, change versus pre dose FEV1

  3. Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1 [ Time Frame: 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

  4. Adverse Events [ Time Frame: At baseline and at each day of treatment ]
    Number of participants with at least 1 AE.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048333


Locations
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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, Italy
Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Sweden
Research Site
Goteborg, Sweden
Research Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Mario Cazzola, professor Italy
Study Director: Georgios Stratelis AstraZeneca MC Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01048333    
Other Study ID Numbers: D5127C00001
First Posted: January 13, 2010    Key Record Dates
Results First Posted: October 25, 2012
Last Update Posted: October 25, 2012
Last Verified: September 2012
Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
Onset of effect
COPD
Oxis Turbuhaler
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action