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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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).

Key facts

Study ID

NCT00801684

Run by

Alkermes, Inc.

People needed

24

Starts

2009-02-01

Expected to finish

2009-07-01

Last updated by the study team

2011-08-19

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spartanburg Medical Research — Spartanburg, South Carolina, United States

Full record on ClinicalTrials.gov

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