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

This study is currently recruiting participants.
Verified February 2012 by Chiesi Farmaceutici S.p.A.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01344655
First received: November 29, 2010
Last updated: November 23, 2012
Last verified: February 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Respiratory Impedance by Impulse oscillometry [ Time Frame: from 5 minutes to 8 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exhaled Nitric Oxide [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
  • Multiple Breath Nitrogen Washout [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]
  • Forced Expiratory Volume in the 1st second [ Time Frame: from 30 minutes to 8 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formoterol 12 μg pMDI (Atimos®) Drug: Atimos®
Formoterol 12 μg pMDI
Other Name: Atimos®
Active Comparator: Salmeterol 25 µg pMDI HFA (Serevent™) Drug: Serevent™
Salmeterol 25 µg pMDI
Other Name: Serevent™
Placebo Comparator: Matched Placebo Drug: Placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344655

Contacts
Contact: Ana Carolina Fernandez, M.Sc +39 0521 279199 C.Fernandez@chiesi.com

Locations
United Kingdom
Airway Disease Section, NHLI, Imperial College London Recruiting
London, United Kingdom, SW3 6LY
Contact: Omar S Usmani, MD     +44 (0) 207 351 8051     o.usmani@imperial.ac.uk    
Principal Investigator: Omar S Usmani, MD            
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Omar S Usmani, MD Imperial College London
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01344655     History of Changes
Other Study ID Numbers: CCD-0901-PR-0012
Study First Received: November 29, 2010
Last Updated: November 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Formoterol
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013