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

March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6LY
        • Airway Disease Section, NHLI, Imperial College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Formoterol 12 μg pMDI (Atimos®)
Drug: Atimos®
Formoterol 12 μg pMDI
Active Comparator: Salmeterol 25 µg pMDI HFA (Serevent™)
Drug: Serevent™
Salmeterol 25 µg pMDI
Placebo Comparator: Matched Placebo
Drug: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory Impedance by Impulse oscillometry
Time Frame: from 5 minutes to 8 hours post dose
from 5 minutes to 8 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Exhaled Nitric Oxide
Time Frame: from 30 minutes to 8 hours post dose
from 30 minutes to 8 hours post dose
Multiple Breath Nitrogen Washout
Time Frame: from 30 minutes to 8 hours post dose
from 30 minutes to 8 hours post dose
Forced Expiratory Volume in the 1st second
Time Frame: from 30 minutes to 8 hours post dose
from 30 minutes to 8 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Omar S Usmani, MD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-0901-PR-0012
  • 2008-008656-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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