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Spiriva® Assessment of FEV1 (SAFE)

NCT ID: NCT00277264

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-05-31

Brief Summary

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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

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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

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tiotropium (Spiriva®)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Canada Ltd.

Locations

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Respiratory Research, Room 1742

Calgary, Alberta, Canada

Site Status

Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

4A-185, 7007-14 Street SW

Calgary, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Lethbridge, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Medicine Hat, Alberta, Canada

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301-131 First Ave.

Spruce Grove, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Wetaskiwin, Alberta, Canada

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Boehringer Ingelheim Investigational Site

Abbotsford, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Maple Ridge, British Columbia, Canada

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220 Royal Avenue

New Westminster, British Columbia, Canada

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Penticton Regional Hospital

Penticton, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

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Boehringer Ingelheim Investigational Site

Steinbach, Manitoba, Canada

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1095 Concordia Avenue

Winnipeg, Manitoba, Canada

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Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, Canada

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Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

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262 Newfoundland Drive

St. John's, Newfoundland and Labrador, Canada

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300 Prince Philip Drive

St. John's, Newfoundland and Labrador, Canada

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Boehringer Ingelheim Investigational Site

New Glasgow, Nova Scotia, Canada

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Boehringer Ingelheim Investigational Site

Sydney, Nova Scotia, Canada

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Boehringer Ingelheim Investigational Site

Ajax, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Courtice, Ontario, Canada

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169 Main Street East

Grimsby, Ontario, Canada

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237 Barton Street East

Hamilton, Ontario, Canada

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HGH McMaster Clinic

Hamilton, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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50 Charlton Avenue East

Hamilton, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Kitchener, Ontario, Canada

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Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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Haemolology Division

London, Ontario, Canada

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St Joseph's Healthcare

London, Ontario, Canada

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Boehringer Ingelheim Investigational Site

London, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

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300-2338 Hurontario Street

Mississauga, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Niagara Falls, Ontario, Canada

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Boehringer Ingelheim Investigational Site

North York, Ontario, Canada

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Boehringer Ingelheim Investigational Site

North York, Ontario, Canada

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Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

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1053 Carling Avenue

Ottawa, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Peterborough, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Richmond Hill, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Thunder Bay, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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825 Coxwell Avenue

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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600 Sherbourne Street, Suite 402

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

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Toronto General Hospital

Toronto, Ontario, Canada

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76 Grenville Street

Toronto, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Trenton, Ontario, Canada

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Boehringer Ingelheim Investigational Site

Windsor, Ontario, Canada

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Boehringer Ingelheim Investigational Site

York, Ontario, Canada

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91 Thomas-Chapais

Boucherville, Quebec, Canada

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305 rue Saint-Vallier

Chicoutimi, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Gatineau, Quebec, Canada

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4 rue Robinson

Granby, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Greenfield Park, Quebec, Canada

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Boehringer Ingelheim Investigational Site

La Malbaie, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Laval, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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2180 rue Fleury E

Montreal, Quebec, Canada

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UHRESS, Pavillon L-C Simard, 10th Floor, Z10904

Montreal, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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Hop du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Pointe-Claire, Quebec, Canada

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1401-18 Rue

Québec, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Saint-Jérôme, Quebec, Canada

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3001 12e ave Nord

Sherbrooke, Quebec, Canada

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Boehringer Ingelheim Investigational Site

St-Jean Richelieu, Quebec, Canada

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Hopital Laval

Ste-Foy, Quebec, Canada

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Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

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Countries

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Canada

Other Identifiers

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205.259

Identifier Type: -

Identifier Source: org_study_id