Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Endo Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: trospium chloride inhalation powder (TrIP); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465959

IP631-024

Details and patient eligibility

About

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

Enrollment: 24 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female COPD patients between the ages of 40 and 80 years
• Smoking history of at least 10 pack years
• Not currently using (or able to wash out of) any long acting bronchodilators

Exclusion criteria

• Candidate on a waiting list for surgery while on study
• Using long-term oxygen therapy
• Hospitalization for COPD exacerbation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

400 mg TrIP

Experimental group

Treatment:

Drug: trospium chloride inhalation powder (TrIP)

800 mg TrIP

Experimental group

Treatment:

Drug: trospium chloride inhalation powder (TrIP)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo