Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients
A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
1 other identifier
interventional
234
1 country
12
Brief Summary
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2002
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedDecember 28, 2017
December 1, 2017
3.6 years
September 7, 2005
December 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
week 13
Secondary Outcomes (14)
Individual FEV1 measurement
week 4, 13, 25
Individual FVC measurement
week 4, 13, 25
St. George's Hospital Respiratory Questionnaire (SGRQ)
Time Frame: week 4, 13, 25
Transition dyspnea index
week 4, 13, 25
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest
week 4, 13, 25
- +9 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
You may not qualify if:
- Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Fondazione "S. Maugeri"
Bari, 70020, Italy
Azienda Sanitaria Locale
Casorate Primo (PV), 27022, Italy
Arcispedale S. Anna
Ferrara, 44100, Italy
U.O. dimedicina Preventiva del Lavoro
Genova, 16132, Italy
Fondazione Maugeri
Gussago (BS), 25064, Italy
Universita degli Studi di Pisa
Pisa, 56124, Italy
Fondazione Don Gnocchi
Pozzolatico (FI), 50020, Italy
Azienda Ospedaliera S. Camillo Forlanini
Roma, 00149, Italy
Fondazione S. Maugeri
Telese Terme (BN), 82037, Italy
Fondazione "S. Maugeri"
Tradate (VA), 21049, Italy
Ospedali Riuniti di Trieste
Trieste, 34100, Italy
Casa di Cura San Raffaele
Velletri (Roma), 00049, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
BI Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
September 1, 2002
Primary Completion
April 1, 2006
Study Completion
April 1, 2006
Last Updated
December 28, 2017
Record last verified: 2017-12