ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Formoterol Fumarate; Triptorelin Pamoate; Trospium chloride

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