Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified September 2012 by Dartmouth-Hitchcock Medical Center
Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
Sunovion
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01391559
First received: July 8, 2011
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR < 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the FEV1 measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: arformoterol Drug: salmeterol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Inhaling Bronchodilator Medications in Patients With Chronic Obstructive Pulmonary Disease Who Have a Low Peak Inspiratory Flow Rate |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Formoterol fumarate
Formoterol
Salmeterol
Salmeterol xinafoate
Arformoterol Tartrate
U.S. FDA Resources
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- change in FEV1 from baseline at two hours after inhalation of the study medication [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change in breathing difficulty on bidirectional scale (-5 to +5) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: arformoterol
beta-2 agonist bronchodilator
|
Drug: arformoterol
15 mcg administered via nebulizer
Other Name: Brovana
|
|
Active Comparator: salmeterol
beta-2 agonist bronchodilator
|
Drug: salmeterol
50 mcg delivered vis Diskus
Other Name: Serevent
|
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- male or female patient 60 years of age or older; diagnosis of COPD; current or former smoker; previous or current use of Diskus device; PIFR < 60 l/min using the In-check DIAL against the resistance of the Diskus device; clinically stable.
Exclusion Criteria:
- any patient who has a concomitant disease that might interfere with study procedures or evaluation; inability to withhold short-acting and long-acting bronchodilators on the days of testing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391559
Contacts
| Contact: Donald A Mahler, M.D. | 603 650-5533 | Donald.a.mahler@hitchcock.org |
| Contact: Laurie A Waterman, MS | 603 650-5729 | Lauire.a.waterman@hitchcock.org |
Locations
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| Contact: Donald A Mahler, M.D. 603-650-5533 Donald.a.mahler@hitchcock.org | |
| Contact: Laurie A Waterman, MS 603 650-5729 Lauire.a.waterman@hitchcock.org | |
| Principal Investigator: Donald A Mahler, M.D. | |
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Sunovion
Investigators
| Principal Investigator: | Donald A Mahler, M.D. | Dartmouth-Hitchcock Medical Center |
More Information
Publications:
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT01391559 History of Changes |
| Other Study ID Numbers: | CPHS22812 |
| Study First Received: | July 8, 2011 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
breathing difficulty |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Bronchodilator Agents Formoterol Salmeterol Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013