N/A
Completed N=20
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01391559 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication — 84; 52 mL — p=0.17
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication |
84; 52 | 0.17 |
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
Data sourced from ClinicalTrials.gov (NCT01391559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.