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

NCT ID: NCT01048333

Last Updated: 2012-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

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)

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease Onset of effect COPD Oxis Turbuhaler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeterol

Intervention Type DRUG

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebo

Intervention Type DRUG

Placebo Diskus and Placebo Turbuhaler

Interventions

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Formoterol

Formoterol Turbuhaler 9 μg and Placebo Diskus

Intervention Type DRUG

Salmeterol

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Intervention Type DRUG

Placebo

Placebo Diskus and Placebo Turbuhaler

Intervention Type DRUG

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario Cazzola, professor

Role: PRINCIPAL_INVESTIGATOR

Italy

Georgios Stratelis

Role: STUDY_DIRECTOR

AstraZeneca MC Sweden

Locations

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Research Site

Bussolengo, , Italy

Site Status

Research Site

Cassano delle Murge, , Italy

Site Status

Research Site

Catanzaro, , Italy

Site Status

Research Site

Cava de' Tirreni, , Italy

Site Status

Research Site

Napoli, , Italy

Site Status

Research Site

Palermo, , Italy

Site Status

Research Site

Parma, , Italy

Site Status

Research Site

Pisa, , Italy

Site Status

Research Site

Prato, , Italy

Site Status

Research Site

Roma, , Italy

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Málaga, , Spain

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Countries

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Italy Spain Sweden

References

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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.

Reference Type DERIVED
PMID: 22235841 (View on PubMed)

Other Identifiers

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D5127C00001

Identifier Type: -

Identifier Source: org_study_id