Spiriva® Assessment of FEV1 (SAFE)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Spiriva® Assessment of FEV1 (SAFE). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Long-term Treatment in Patients With COPD. A One-year Parallel Group, Double-blind, Randomised, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277264
• Other study ID #: 205.259
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: November 5, 2013
• Start date: January 2002
• Est. completion date: May 2004

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Therapeutic Products Directorate branch of Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium (Spiriva®)

Locations

Country	Name	City	State
Canada	Boehringer Ingelheim Investigational Site	Abbotsford	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Ajax	Ontario
Canada	91 Thomas-Chapais	Boucherville	Quebec
Canada	4A-185, 7007-14 Street SW	Calgary	Alberta
Canada	Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	Respiratory Research, Room 1742	Calgary	Alberta
Canada	305 rue Saint-Vallier	Chicoutimi	Quebec
Canada	Boehringer Ingelheim Investigational Site	Chilliwack	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Corunna	Ontario
Canada	Boehringer Ingelheim Investigational Site	Courtice	Ontario
Canada	Boehringer Ingelheim Investigational Site	Edmonton	Alberta
Canada	Boehringer Ingelheim Investigational Site	Gatineau	Quebec
Canada	4 rue Robinson	Granby	Quebec
Canada	Boehringer Ingelheim Investigational Site	Greenfield Park	Quebec
Canada	169 Main Street East	Grimsby	Ontario
Canada	237 Barton Street East	Hamilton	Ontario
Canada	50 Charlton Avenue East	Hamilton	Ontario
Canada	Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	HGH McMaster Clinic	Hamilton	Ontario
Canada	Boehringer Ingelheim Investigational Site	Kelowna	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Kingston	Ontario
Canada	Boehringer Ingelheim Investigational Site	Kitchener	Ontario
Canada	Boehringer Ingelheim Investigational Site	La Malbaie	Quebec
Canada	Boehringer Ingelheim Investigational Site	Laval	Quebec
Canada	Boehringer Ingelheim Investigational Site	Lethbridge	Alberta
Canada	Boehringer Ingelheim Investigational Site	London	Ontario
Canada	Boehringer Ingelheim Investigational Site	London	Ontario
Canada	Boehringer Ingelheim Investigational Site	London	Ontario
Canada	Haemolology Division	London	Ontario
Canada	St Joseph's Healthcare	London	Ontario
Canada	Boehringer Ingelheim Investigational Site	Maple Ridge	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Markham	Ontario
Canada	Boehringer Ingelheim Investigational Site	Medicine Hat	Alberta
Canada	300-2338 Hurontario Street	Mississauga	Ontario
Canada	Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	Boehringer Ingelheim Investigational Site	Mississauga	Ontario
Canada	2180 rue Fleury E	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Montreal	Quebec
Canada	Hop du Sacre-Coeur de Montreal	Montreal	Quebec
Canada	UHRESS, Pavillon L-C Simard, 10th Floor, Z10904	Montreal	Quebec
Canada	Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador
Canada	Boehringer Ingelheim Investigational Site	New Glasgow	Nova Scotia
Canada	220 Royal Avenue	New Westminster	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Niagara Falls	Ontario
Canada	Boehringer Ingelheim Investigational Site	North York	Ontario
Canada	Boehringer Ingelheim Investigational Site	North York	Ontario
Canada	1053 Carling Avenue	Ottawa	Ontario
Canada	Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Penticton Regional Hospital	Penticton	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Peterborough	Ontario
Canada	Boehringer Ingelheim Investigational Site	Pointe Claire	Quebec
Canada	1401-18 Rue	Quebec
Canada	Boehringer Ingelheim Investigational Site	Richmond Hill	Ontario
Canada	Boehringer Ingelheim Investigational Site	Saint Jerome	Quebec
Canada	Boehringer Ingelheim Investigational Site	Saint John	New Brunswick
Canada	Boehringer Ingelheim Investigational Site	Sarnia	Ontario
Canada	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	Boehringer Ingelheim Investigational Site	Scarborough	Ontario
Canada	3001 12e ave Nord	Sherbrooke	Quebec
Canada	301-131 First Ave.	Spruce Grove	Alberta
Canada	Boehringer Ingelheim Investigational Site	St-Jean Richelieu	Quebec
Canada	262 Newfoundland Drive	St. John's	Newfoundland and Labrador
Canada	300 Prince Philip Drive	St. John's	Newfoundland and Labrador
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	Boehringer Ingelheim Investigational Site	Steinbach	Manitoba
Canada	Boehringer Ingelheim Investigational Site	Surrey	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Sydney	Nova Scotia
Canada	Boehringer Ingelheim Investigational Site	Thunder Bay	Ontario
Canada	600 Sherbourne Street, Suite 402	Toronto	Ontario
Canada	76 Grenville Street	Toronto	Ontario
Canada	825 Coxwell Avenue	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Boehringer Ingelheim Investigational Site	Trenton	Ontario
Canada	Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Victoria	British Columbia
Canada	Boehringer Ingelheim Investigational Site	Wetaskiwin	Alberta
Canada	Boehringer Ingelheim Investigational Site	Windsor	Ontario
Canada	1095 Concordia Avenue	Winnipeg	Manitoba
Canada	Boehringer Ingelheim Investigational Site	York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment.		after 48 weeks of treatment	No
Secondary	The change from baseline FEV1 at interim visits		at Week 2, 11, 30 and 48	No
Secondary	The change from baseline FVC		at Week 2, 11, 30 and 48	No
Secondary	The change from baseline FEV6 (at selected sites)		at Week 2, 11, 30 and 48	No
Secondary	Incidence, severity and duration of COPD exacerbations		at Week 2, 11, 30, 48 and 50	No
Secondary	Incidence and duration of hospitalisations due to COPD exacerbations		at Week 2, 11, 30, 48 and 50	No
Secondary	Use of rescue medication (day-time and night-time) during treatment period		week 1 until week 48	No
Secondary	Number of short courses of steroids/antibiotics during treatment period		week 1 until week 48	No
Secondary	Assessment of COPD symptoms		at Week 2, 11, 30 and 48	No
Secondary	Physician's Global Evaluation		baseline and week 48	No
Secondary	Quality of life questionnaire (SGRQ)		at week 30 and 48	No
Secondary	Adverse events		27 months	No
Secondary	Vital Signs		27 months	No

External Links

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