Efficacy of Inhaling Bronchodilator Medications in Patients With Chronic Obstructive Pulmonary Disease Who Have a Low Peak Inspiratory Flow Rate
Overview
- Phase
- Not Applicable
- Intervention
- arformoterol
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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 forced expiratory volume in 1 second (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.
Investigators
Eligibility 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
Arms & Interventions
arformoterol
beta-2 agonist bronchodilator
Intervention: arformoterol
salmeterol
beta-2 agonist bronchodilator
Intervention: salmeterol
Outcomes
Primary Outcomes
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication
Time Frame: 2 hours
FEV1