Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Verified date | May 2011 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 disease (COPD).
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Spartanburg Medical Research | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) | Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 µg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 µg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 µg TrCl) Dose E = TrIP-2SS (100 µg TrCl) + Foradil (12 µg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose. |
15 minutes to 24 hours post-treatment | No |
Secondary | FEV1 Response to Treatment | Response was defined as the number of subjects reporting a post-treatment FEV1 of =12% (or 200 mL) above baseline. | Up to 24 hours post-treatment | No |
Secondary | Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP | Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma. | up to 24 hours post-treatment | No |
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