A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)
Overview
- Phase
- Phase 4
- Intervention
- tiotropium
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 140
- Locations
- 27
- Primary Endpoint
- Trough FEV1 After 12 Weeks on Study Drug
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
tiotropium 18mcg
active
Intervention: tiotropium
Placebo
placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Trough FEV1 After 12 Weeks on Study Drug
Time Frame: 12 weeks
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Secondary Outcomes
- Time to Recovery From Acute Respiratory Symptoms(12 weeks)
- Trough FVC (in Litres) at 12 Weeks(12 weeks)
- Responder Status at Week 4 Clinic Visit(4 weeks)
- Responder Status at Week 12 Clinic Visit(12 weeks)
- Weekly Rescue Medication Use Over the 12 Weeks of Study(12 weeks)