Phase 2
Completed N=24
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Source: ClinicalTrials.gov NCT00801684 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) — 1.707; 1.696; 1.672; 1.676 Liters — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) |
1.707; 1.696; 1.672; 1.676; 1.508 | <0.0001 sig |
| SECONDARY FEV1 Response to Treatment |
23; 22; 22; 21; 14 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP |
0.08; 0.08; 0.08; 0.08 | — |
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
Data sourced from ClinicalTrials.gov (NCT00801684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.