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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01344655
First received: November 29, 2010
Last updated: July 29, 2013
Last verified: July 2013
  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:


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 ]

Enrollment: 16
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: September 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

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
  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: July 29, 2013
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 April 15, 2014