Spiriva® Assessment of FEV1 (SAFE)

NCT00277264 | Completed Phase 3

• 1 other identifier: 205.259
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 96

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment.

  after 48 weeks of treatment

Secondary Outcomes (12)

• 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

Interventions

Tiotropium (Spiriva®) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (96)

Respiratory Research, Room 1742

Calgary, Alberta, T1Y 6J4, Canada

Location

Boehringer Ingelheim Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

4A-185, 7007-14 Street SW

Calgary, Alberta, T2V 1P9, Canada

Location

Boehringer Ingelheim Investigational Site

Edmonton, Alberta, T5G 3G6, Canada

Location

Boehringer Ingelheim Investigational Site

Lethbridge, Alberta, T1J 0Z2, Canada

Location

Boehringer Ingelheim Investigational Site

Medicine Hat, Alberta, T1A 4E4, Canada

Location

301-131 First Ave.

Spruce Grove, Alberta, T7X 2Z8, Canada

Location

Boehringer Ingelheim Investigational Site

Wetaskiwin, Alberta, T9A 3N3, Canada

Location

Boehringer Ingelheim Investigational Site

Abbotsford, British Columbia, V2S 6R6, Canada

Location

Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, V2P 4M9, Canada

Location

Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, V1W 3T1, Canada

Location

Boehringer Ingelheim Investigational Site

Maple Ridge, British Columbia, V2X 2L5, Canada

Location

220 Royal Avenue

New Westminster, British Columbia, V3L 1H6, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

Boehringer Ingelheim Investigational Site

Surrey, British Columbia, V3V 1N1, Canada

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, V5Z 3J5, Canada

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, V6Z !Y6, Canada

Location

Boehringer Ingelheim Investigational Site

Victoria, British Columbia, V8R 6V4, Canada

Location

Boehringer Ingelheim Investigational Site

Steinbach, Manitoba, R0A 2T3, Canada

Location

1095 Concordia Avenue

Winnipeg, Manitoba, R2K 3S8, Canada

Location

Boehringer Ingelheim Investigational Site

Saint John, New Brunswick, E2M 3W5, Canada

Location

Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada

Location

262 Newfoundland Drive

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

300 Prince Philip Drive

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Boehringer Ingelheim Investigational Site

New Glasgow, Nova Scotia, B2H 1K1, Canada

Location

Boehringer Ingelheim Investigational Site

Sydney, Nova Scotia, B1P 1P3, Canada

Location

Boehringer Ingelheim Investigational Site

Ajax, Ontario, L1S 2J5, Canada

Location

Boehringer Ingelheim Investigational Site

Corunna, Ontario, N0N 1G0, Canada

Location

Boehringer Ingelheim Investigational Site

Courtice, Ontario, L1E 3C3, Canada

Location

169 Main Street East

Grimsby, Ontario, L3M 1P3, Canada

Location

237 Barton Street East

Hamilton, Ontario, L8L 2X2, Canada

Location

HGH McMaster Clinic

Hamilton, Ontario, L8L 2X2, Canada

Location

Boehringer Ingelheim Investigational Site

Hamilton, Ontario, L8M 1K7, Canada

Location

50 Charlton Avenue East

Hamilton, Ontario, L8N 4A6, Canada

Location

Boehringer Ingelheim Investigational Site

Hamilton, Ontario, L8V 1C1, Canada

Location

Boehringer Ingelheim Investigational Site

Kingston, Ontario, K7L 5E4, Canada

Location

Boehringer Ingelheim Investigational Site

Kitchener, Ontario, N2C 2N9, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N5W 6A2, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N6A 4G5, Canada

Location

Haemolology Division

London, Ontario, N6A 4G5, Canada

Location

St Joseph's Healthcare

London, Ontario, N6A 4V2, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, N6A 5R9, Canada

Location

Boehringer Ingelheim Investigational Site

Markham, Ontario, L6B 1A1, Canada

Location

Boehringer Ingelheim Investigational Site

Mississauga, Ontario, L4W 1N2, Canada

Location

300-2338 Hurontario Street

Mississauga, Ontario, L5B 1N1, Canada

Location

Boehringer Ingelheim Investigational Site

Mississauga, Ontario, L5M 2V8, Canada

Location

Boehringer Ingelheim Investigational Site

Niagara Falls, Ontario, L2G 1J4, Canada

Location

Boehringer Ingelheim Investigational Site

North York, Ontario, M2K 2W2, Canada

Location

Boehringer Ingelheim Investigational Site

North York, Ontario, M2K 2Z3, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

1053 Carling Avenue

Ottawa, Ontario, K1Y 4E9, Canada

Location

Boehringer Ingelheim Investigational Site

Ottawa, Ontario, K1Y 4G2, Canada

Location

Boehringer Ingelheim Investigational Site

Ottawa, Ontario, K1Y 4P6, Canada

Location

Boehringer Ingelheim Investigational Site

Peterborough, Ontario, K9J 7H8, Canada

Location

Boehringer Ingelheim Investigational Site

Richmond Hill, Ontario, L4C 2N9, Canada

Location

Boehringer Ingelheim Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, M1B 4Z8, Canada

Location

Boehringer Ingelheim Investigational Site

Thunder Bay, Ontario, P7E 1G6, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M1P 2T3, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M1S 4V5, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M1W 2R6, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M3C 3G8, Canada

Location

825 Coxwell Avenue

Toronto, Ontario, M4C 3E7, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M4M 1J5, Canada

Location

600 Sherbourne Street, Suite 402

Toronto, Ontario, M4X 1W4, Canada

Location

Boehringer Ingelheim Investigational Site

Toronto, Ontario, M5G 1E2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

76 Grenville Street

Toronto, Ontario, M5S 1B2, Canada

Location

Boehringer Ingelheim Investigational Site

Trenton, Ontario, K8V 6H9, Canada

Location

Boehringer Ingelheim Investigational Site

Windsor, Ontario, N9A 1C9, Canada

Location

Boehringer Ingelheim Investigational Site

York, Ontario, M9N 1J4, Canada

Location

91 Thomas-Chapais

Boucherville, Quebec, J4B 6P3, Canada

Location

305 rue Saint-Vallier

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Boehringer Ingelheim Investigational Site

Gatineau, Quebec, J8P 7H2, Canada

Location

4 rue Robinson

Granby, Quebec, J2G 8Z9, Canada

Location

Boehringer Ingelheim Investigational Site

Greenfield Park, Quebec, J4V 2G8, Canada

Location

Boehringer Ingelheim Investigational Site

La Malbaie, Quebec, G5A 1W7, Canada

Location

Boehringer Ingelheim Investigational Site

Laval, Quebec, H7V 3Y7, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H1V 1X4, Canada

Location

2180 rue Fleury E

Montreal, Quebec, H2B 1K3, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H3H 1V4, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Hop du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Boehringer Ingelheim Investigational Site

Montreal, Quebec, H4N 2W2, Canada

Location

Boehringer Ingelheim Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

1401-18 Rue

Québec, Quebec, G1J 1Z4, Canada

Location

Boehringer Ingelheim Investigational Site

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

3001 12e ave Nord

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Boehringer Ingelheim Investigational Site

St-Jean Richelieu, Quebec, J3A 1C3, Canada

Location

Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7H 5M3, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, S7L 2W1, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Canada Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 16, 2006
• Study Start: January 1, 2002
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

CA (96)