Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients

NCT ID: NCT01344655

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Detailed Description

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A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formoterol 12 μg pMDI (Atimos®)

Group Type EXPERIMENTAL

Atimos®

Intervention Type DRUG

Formoterol 12 μg pMDI

Salmeterol 25 µg pMDI HFA (Serevent™)

Group Type ACTIVE_COMPARATOR

Serevent™

Intervention Type DRUG

Salmeterol 25 µg pMDI

Matched Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Atimos®

Formoterol 12 μg pMDI

Intervention Type DRUG

Serevent™

Salmeterol 25 µg pMDI

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a clinical diagnosis of COPD
* Post bronchodilator FEV1 between 30% and 80% predicted values at screening
* Post-bronchodilator FEV1/FVC \< 0.7

Exclusion Criteria

* Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
* History of another medical condition contraindicating participation in the study
* Clinical evidence of heart failure
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omar S Usmani, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Airway Disease Section, NHLI, Imperial College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-008656-16

Study Record on EU Clinical Trials Register including results

Other Identifiers

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2008-008656-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-0901-PR-0012

Identifier Type: -

Identifier Source: org_study_id

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