Status:
COMPLETED
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Lead Sponsor:
Alkermes, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary diseas...
Detailed Description
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a tota...
Eligibility Criteria
Inclusion
- Male or female COPD subjects between the ages of 40 and 80 years
- Body mass index between 18 and 35
- Medically healthy (other than COPD)
- FEV1/FVC less than or equal to 0.70
- Current non-smoker or able to abstain from smoking for at least 8 hours postdose
- Within the previous 6 months, demonstrated improvement in FEV1 (greater than or equal to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs)
- Females of childbearing potential must agree to use an acceptable method of contraception for the duration of the study
Exclusion
- Asthma in the last 10 years
- Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis
- Bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication
- Narrow angle glaucoma
- Tachyarrhythmia
- Alcohol dependence or illicit drug abuse within the past year
- Using long-term oxygen therapy
- Female subjects who are pregnant or breastfeeding
- Participating in another clinical trial
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00801684
Start Date
February 1 2009
End Date
July 1 2009
Last Update
August 19 2011
Active Locations (1)
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1
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303