Clinical trial NCT00801684: ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Official title: Efficacy, Safety, Tolerability, and Pharmacokinetics of Trospium Inhalation Powder (TrIP) Administered to Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
pulmonary
inhalation
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 disease (COPD).

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 total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.

Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.

Eligibility criteria: 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

Primary outcomes:
measure: Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)
timeFrame: 15 minutes to 24 hours post-treatment
Secondary outcomes:
measure: FEV1 Response to Treatment
timeFrame: Up to 24 hours post-treatment
measure: Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP
timeFrame: up to 24 hours post-treatment
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References: