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

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ClinicalTrials.gov Identifier: NCT01344655
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Atimos® Drug: Serevent™ Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Respiratory Impedance by Impulse oscillometry [ Time Frame: from 5 minutes to 8 hours post dose ]

Secondary Outcome Measures :
  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 ]


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

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

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): NCT01344655


Locations
United Kingdom
Airway Disease Section, NHLI, Imperial College London
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Omar S Usmani, MD Imperial College London

Additional Information:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01344655     History of Changes
Other Study ID Numbers: CCD-0901-PR-0012
2008-008656-16 ( EudraCT Number )
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
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