Spiriva® Assessment of FEV1 (SAFE)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00277264
- Lead Sponsor
- Boehringer Ingelheim
- 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 placebo in patients with COPD, is affected by smoking status.
- 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 screening visit consisted of medical history, clinical assessment, safety laboratory assessments and complete pulmonary function testing. The screening period was followed by a randomised treatment period where patients received tiotropium (Spiriva) or placebo in a ratio of 2:1. During the treatment period there were a total of 5 clinic visits (including randomisation and EOT visit). Each visit included lung function measurements and clinical assessments (SQRQ, COPD Symptom scores, physician's global assessment, COPD exacerbations/hospitalisations, vital signs and rescue medication use) in addition to adverse event reporting. The final visit consisted of a telephone contact 2 weeks after the patient completed their trial medication.
Study Hypothesis:
The primary purpose of this trial was to evaluate whether the effect of inhaled tiotropium (Spiriva®) on the change in trough FEV1, compared to placebo, was affected by smoking status. The primary endpoint was defined as the change in trough FEV1 after 48 weeks of treatment. The primary analysis was performed in a sequential fashion; firstly, the analysis was performed for all patients and if a positive signal was seen in this group, the analysis was then performed for both the smoking and ex-smoking groups separately. Patients were defined as smokers or ex-smokers at the screening visit.
Comparison(s):
Tiotropium (Spiriva®) vs placebo
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 914
- 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®
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment. after 48 weeks of treatment
- Secondary Outcome Measures
Name Time Method Number of short courses of steroids/antibiotics during treatment period week 1 until week 48 The change from baseline FEV1 at interim visits at Week 2, 11, 30 and 48 The change from baseline FVC at Week 2, 11, 30 and 48 The change from baseline FEV6 (at selected sites) at Week 2, 11, 30 and 48 Incidence, severity and duration of COPD exacerbations at Week 2, 11, 30, 48 and 50 Incidence and duration of hospitalisations due to COPD exacerbations at Week 2, 11, 30, 48 and 50 Use of rescue medication (day-time and night-time) during treatment period week 1 until week 48 Assessment of COPD symptoms at Week 2, 11, 30 and 48 Physician's Global Evaluation baseline and week 48 Vital Signs 27 months Quality of life questionnaire (SGRQ) at week 30 and 48 Adverse events 27 months
Trial Locations
- Locations (31)
Penticton Regional Hospital
🇨🇦Penticton, British Columbia, Canada
220 Royal Avenue
🇨🇦New Westminster, British Columbia, Canada
825 Coxwell Avenue
🇨🇦Toronto, Ontario, Canada
2180 rue Fleury E
🇨🇦Montreal, Quebec, Canada
UHRESS, Pavillon L-C Simard, 10th Floor, Z10904
🇨🇦Montreal, Quebec, Canada
Hop du Sacre-Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
1401-18 Rue
🇨🇦Quebec, Canada
4A-185, 7007-14 Street SW
🇨🇦Calgary, Alberta, Canada
237 Barton Street East
🇨🇦Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
🇨🇦Saskatoon, Saskatchewan, Canada
Respiratory Research, Room 1742
🇨🇦Calgary, Alberta, Canada
HGH McMaster Clinic
🇨🇦Hamilton, Ontario, Canada
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
300 Prince Philip Drive
🇨🇦St. John's, Newfoundland and Labrador, Canada
300-2338 Hurontario Street
🇨🇦Mississauga, Ontario, Canada
600 Sherbourne Street, Suite 402
🇨🇦Toronto, Ontario, Canada
169 Main Street East
🇨🇦Grimsby, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
305 rue Saint-Vallier
🇨🇦Chicoutimi, Quebec, Canada
Hopital Laval
🇨🇦Ste-Foy, Quebec, Canada
Haemolology Division
🇨🇦London, Ontario, Canada
50 Charlton Avenue East
🇨🇦Hamilton, Ontario, Canada
301-131 First Ave.
🇨🇦Spruce Grove, Alberta, Canada
91 Thomas-Chapais
🇨🇦Boucherville, Quebec, Canada
St Joseph's Healthcare
🇨🇦London, Ontario, Canada
1095 Concordia Avenue
🇨🇦Winnipeg, Manitoba, Canada
1053 Carling Avenue
🇨🇦Ottawa, Ontario, Canada
76 Grenville Street
🇨🇦Toronto, Ontario, Canada
3001 12e ave Nord
🇨🇦Sherbrooke, Quebec, Canada
4 rue Robinson
🇨🇦Granby, Quebec, Canada
262 Newfoundland Drive
🇨🇦St. John's, Newfoundland and Labrador, Canada