Status:
COMPLETED
Spiriva® Assessment of FEV1 (SAFE)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The objective of this trial is to evaluate whether the effect of one year (48 weeks) treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in trough FEV1, compared to p...
Detailed Description
This was a multi-centre, randomised, double-blind, placebo-controlled study. The duration of subject participation was 48 weeks. There was an initial screening period of up to 2 weeks. The first scree...
Eligibility Criteria
Inclusion
- Diagnosis of COPD
- Stable airway obstruction
- FEV1 \< or equal to 65% of predicted
- Male or female
- Age \> or equal to 40 years
- \> or equal to 10 pack year smoking history
- History of exacerbations in the past year
- Able to be trained in the proper use of the HandiHaler®
Exclusion
- History of asthma
- Allergic rhinitis or atopy
- Unstable use (6 weeks) of OCS (or \> 10 mg daily use)
- History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis
- Patients who had started or stopped an exercise rehabilitation program in the past twelve months
- Thoracotomy with pulmonary resection or lobectomy (LVRS)
- Active tuberculosis
- Use of beta-blockers
- Pregnant, nursing women and women of childbearing potential not using a medically approved means of contraception
- 6 months or less history of myocardial infarction
- Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system
- History of unstable arrhythmia with a life threatening event or change of related therapy during the past year
- History of cancer, other than treated basal cell carcinoma, within the last 12 months
- Clinically relevant abnormal baseline haematology, blood chemistry or urinalysis
- Patients with narrow angle glaucoma
- Patients with symptomatic benign prostatic hypertrophy
- Patients with bladder neck obstruction
- Patients that planned to be out of the country for 8 weeks or more
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
914 Patients enrolled
Trial Details
Trial ID
NCT00277264
Start Date
January 1 2002
End Date
May 1 2004
Last Update
November 6 2013
Active Locations (96)
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1
Respiratory Research, Room 1742
Calgary, Alberta, Canada, T1Y 6J4
2
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada, T2N 4N1
3
4A-185, 7007-14 Street SW
Calgary, Alberta, Canada, T2V 1P9
4
Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada, T5G 3G6