Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients (Imperial)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Atimos®
Serevent™
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility 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
Sites / Locations
- Airway Disease Section, NHLI, Imperial College London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Formoterol 12 μg pMDI (Atimos®)
Salmeterol 25 µg pMDI HFA (Serevent™)
Matched Placebo
Arm Description
Outcomes
Primary Outcome Measures
Respiratory Impedance by Impulse oscillometry
Secondary Outcome Measures
Exhaled Nitric Oxide
Multiple Breath Nitrogen Washout
Forced Expiratory Volume in the 1st second
Full Information
NCT ID
NCT01344655
First Posted
November 29, 2010
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01344655
Brief Title
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
Acronym
Imperial
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formoterol 12 μg pMDI (Atimos®)
Arm Type
Experimental
Arm Title
Salmeterol 25 µg pMDI HFA (Serevent™)
Arm Type
Active Comparator
Arm Title
Matched Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atimos®
Intervention Description
Formoterol 12 μg pMDI
Intervention Type
Drug
Intervention Name(s)
Serevent™
Intervention Description
Salmeterol 25 µg pMDI
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Respiratory Impedance by Impulse oscillometry
Time Frame
from 5 minutes to 8 hours post dose
Secondary Outcome Measure Information:
Title
Exhaled Nitric Oxide
Time Frame
from 30 minutes to 8 hours post dose
Title
Multiple Breath Nitrogen Washout
Time Frame
from 30 minutes to 8 hours post dose
Title
Forced Expiratory Volume in the 1st second
Time Frame
from 30 minutes to 8 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar S Usmani, MD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Airway Disease Section, NHLI, Imperial College London
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-008656-16
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
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