Spiriva® Assessment of FEV1 (SAFE)

November 5, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

914

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • 1401-18 Rue
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Respiratory Research, Room 1742
      • Calgary, Alberta, Canada, T2N 4N1
        • Boehringer Ingelheim Investigational Site
      • Calgary, Alberta, Canada, T2V 1P9
        • 4A-185, 7007-14 Street SW
      • Edmonton, Alberta, Canada, T5G 3G6
        • Boehringer Ingelheim Investigational Site
      • Lethbridge, Alberta, Canada, T1J 0Z2
        • Boehringer Ingelheim Investigational Site
      • Medicine Hat, Alberta, Canada, T1A 4E4
        • Boehringer Ingelheim Investigational Site
      • Spruce Grove, Alberta, Canada, T7X 2Z8
        • 301-131 First Ave.
      • Wetaskiwin, Alberta, Canada, T9A 3N3
        • Boehringer Ingelheim Investigational Site
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 6R6
        • Boehringer Ingelheim Investigational Site
      • Chilliwack, British Columbia, Canada, V2P 4M9
        • Boehringer Ingelheim Investigational Site
      • Kelowna, British Columbia, Canada, V1W 3T1
        • Boehringer Ingelheim Investigational Site
      • Maple Ridge, British Columbia, Canada, V2X 2L5
        • Boehringer Ingelheim Investigational Site
      • New Westminster, British Columbia, Canada, V3L 1H6
        • 220 Royal Avenue
      • Penticton, British Columbia, Canada, V2A 3G6
        • Penticton Regional Hospital
      • Surrey, British Columbia, Canada, V3V 1N1
        • Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, Canada, V6Z !Y6
        • Boehringer Ingelheim Investigational Site
      • Victoria, British Columbia, Canada, V8R 6V4
        • Boehringer Ingelheim Investigational Site
    • Manitoba
      • Steinbach, Manitoba, Canada, R0A 2T3
        • Boehringer Ingelheim Investigational Site
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • 1095 Concordia Avenue
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2M 3W5
        • Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 2C3
        • Boehringer Ingelheim Investigational Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • 262 Newfoundland Drive
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • 300 Prince Philip Drive
    • Nova Scotia
      • New Glasgow, Nova Scotia, Canada, B2H 1K1
        • Boehringer Ingelheim Investigational Site
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Boehringer Ingelheim Investigational Site
      • Corunna, Ontario, Canada, N0N 1G0
        • Boehringer Ingelheim Investigational Site
      • Courtice, Ontario, Canada, L1E 3C3
        • Boehringer Ingelheim Investigational Site
      • Grimsby, Ontario, Canada, L3M 1P3
        • 169 Main Street East
      • Hamilton, Ontario, Canada, L8M 1K7
        • Boehringer Ingelheim Investigational Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • 237 Barton Street East
      • Hamilton, Ontario, Canada, L8L 2X2
        • HGH McMaster Clinic
      • Hamilton, Ontario, Canada, L8N 4A6
        • 50 Charlton Avenue East
      • Hamilton, Ontario, Canada, L8V 1C1
        • Boehringer Ingelheim Investigational Site
      • Kingston, Ontario, Canada, K7L 5E4
        • Boehringer Ingelheim Investigational Site
      • Kitchener, Ontario, Canada, N2C 2N9
        • Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada, N5W 6A2
        • Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Boehringer Ingelheim Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Haemolology Division
      • London, Ontario, Canada, N6A 4V2
        • St Joseph's Healthcare
      • London, Ontario, Canada, N6A 5R9
        • Boehringer Ingelheim Investigational Site
      • Markham, Ontario, Canada, L6B 1A1
        • Boehringer Ingelheim Investigational Site
      • Mississauga, Ontario, Canada, L4W 1N2
        • Boehringer Ingelheim Investigational Site
      • Mississauga, Ontario, Canada, L5B 1N1
        • 300-2338 Hurontario Street
      • Mississauga, Ontario, Canada, L5M 2V8
        • Boehringer Ingelheim Investigational Site
      • Niagara Falls, Ontario, Canada, L2G 1J4
        • Boehringer Ingelheim Investigational Site
      • North York, Ontario, Canada, M2K 2W2
        • Boehringer Ingelheim Investigational Site
      • North York, Ontario, Canada, M2K 2Z3
        • Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital - General Campus
      • Ottawa, Ontario, Canada, K1Y 4E9
        • 1053 Carling Avenue
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4P6
        • Boehringer Ingelheim Investigational Site
      • Peterborough, Ontario, Canada, K9J 7H8
        • Boehringer Ingelheim Investigational Site
      • Richmond Hill, Ontario, Canada, L4C 2N9
        • Boehringer Ingelheim Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Boehringer Ingelheim Investigational Site
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Boehringer Ingelheim Investigational Site
      • Thunder Bay, Ontario, Canada, P7E 1G6
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada, M1P 2T3
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M1S 4V5
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M1W 2R6
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M3C 3G8
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M4C 3E7
        • 825 Coxwell Avenue
      • Toronto, Ontario, Canada, M4M 1J5
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M4X 1W4
        • 600 Sherbourne Street, Suite 402
      • Toronto, Ontario, Canada, M5G 1E2
        • Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada, M5S 1B2
        • 76 Grenville Street
      • Trenton, Ontario, Canada, K8V 6H9
        • Boehringer Ingelheim Investigational Site
      • Windsor, Ontario, Canada, N9A 1C9
        • Boehringer Ingelheim Investigational Site
      • York, Ontario, Canada, M9N 1J4
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Boucherville, Quebec, Canada, J4B 6P3
        • 91 Thomas-Chapais
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • 305 rue Saint-Vallier
      • Gatineau, Quebec, Canada, J8P 7H2
        • Boehringer Ingelheim Investigational Site
      • Granby, Quebec, Canada, J2G 8Z9
        • 4 rue Robinson
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Boehringer Ingelheim Investigational Site
      • La Malbaie, Quebec, Canada, G5A 1W7
        • Boehringer Ingelheim Investigational Site
      • Laval, Quebec, Canada, H7V 3Y7
        • Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada, H3H 1V4
        • Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada, H1V 1X4
        • Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada, H2B 1K3
        • 2180 rue Fleury E
      • Montreal, Quebec, Canada, H2L 4M1
        • UHRESS, Pavillon L-C Simard, 10th Floor, Z10904
      • Montreal, Quebec, Canada, H3T 1E2
        • Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Hop du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H4N 2W2
        • Boehringer Ingelheim Investigational Site
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Boehringer Ingelheim Investigational Site
      • Saint Jerome, Quebec, Canada, J7Z 5T3
        • Boehringer Ingelheim Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • 3001 12e ave Nord
      • St-Jean Richelieu, Quebec, Canada, J3A 1C3
        • Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Hôpital Laval
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Boehringer Ingelheim Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7H 5M3
        • Boehringer Ingelheim Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Boehringer Ingelheim Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7L 2W1
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment.
Time Frame: after 48 weeks of treatment
after 48 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 27 months
27 months
The change from baseline FEV1 at interim visits
Time Frame: at Week 2, 11, 30 and 48
at Week 2, 11, 30 and 48
The change from baseline FVC
Time Frame: at Week 2, 11, 30 and 48
at Week 2, 11, 30 and 48
The change from baseline FEV6 (at selected sites)
Time Frame: at Week 2, 11, 30 and 48
at Week 2, 11, 30 and 48
Incidence, severity and duration of COPD exacerbations
Time Frame: at Week 2, 11, 30, 48 and 50
at Week 2, 11, 30, 48 and 50
Incidence and duration of hospitalisations due to COPD exacerbations
Time Frame: at Week 2, 11, 30, 48 and 50
at Week 2, 11, 30, 48 and 50
Use of rescue medication (day-time and night-time) during treatment period
Time Frame: week 1 until week 48
week 1 until week 48
Number of short courses of steroids/antibiotics during treatment period
Time Frame: week 1 until week 48
week 1 until week 48
Assessment of COPD symptoms
Time Frame: at Week 2, 11, 30 and 48
at Week 2, 11, 30 and 48
Physician's Global Evaluation
Time Frame: baseline and week 48
baseline and week 48
Quality of life questionnaire (SGRQ)
Time Frame: at week 30 and 48
at week 30 and 48
Vital Signs
Time Frame: 27 months
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Canada Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

May 1, 2004

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Disease, Chronic Obstructive

Clinical Trials on Tiotropium (Spiriva®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe