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Completed

NCT Number: NCT01344655

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Airway Disease Section, NHLI, Imperial College London

London, SW3 6LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atimos®

Drug

Formoterol 12 μg pMDI

Serevent™

Drug

Salmeterol 25 µg pMDI

Placebo

Drug

placebo

Primary outcomes

  1. Respiratory Impedance by Impulse oscillometry

    Time frame: from 5 minutes to 8 hours post dose

Secondary outcomes

  1. Exhaled Nitric Oxide

    Time frame: from 30 minutes to 8 hours post dose

  2. Multiple Breath Nitrogen Washout

    Time frame: from 30 minutes to 8 hours post dose

  3. Forced Expiratory Volume in the 1st second

    Time frame: from 30 minutes to 8 hours post dose

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: Imperial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2011
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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