AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT00277264

Spiriva® Assessment of FEV1 (SAFE)

A Phase 3 study testing Tiotropium (Spiriva®) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 96 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium (Spiriva®)
How many people
914 participants
Where
96 sitesCanada
Study dates
Jan 2002to May 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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®

Who cannot join

  • 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)
Show all 18Show fewer
  • 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

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

Canada96 sites

  • Boehringer Ingelheim Investigational Site

    Abbotsford British Columbia, British Columbia, V2S 6R6

  • Boehringer Ingelheim Investigational Site

    Ajax, Ontario, L1S 2J5

  • 91 Thomas-Chapais

    Boucherville, Quebec, J4B 6P3

  • Respiratory Research, Room 1742

    Calgary, Alberta, T1Y 6J4

  • Boehringer Ingelheim Investigational Site

    Calgary, Alberta, T2N 4N1

  • 4A-185, 7007-14 Street SW

    Calgary, Alberta, T2V 1P9

  • 305 rue Saint-Vallier

    Chicoutimi, Quebec, G7H 5H6

  • Boehringer Ingelheim Investigational Site

    Chilliwack, British Columbia, V2P 4M9

  • Boehringer Ingelheim Investigational Site

    Corunna, Ontario, N0N 1G0

  • Boehringer Ingelheim Investigational Site

    Courtice, Ontario, L1E 3C3

  • Boehringer Ingelheim Investigational Site

    Edmonton, Alberta, T5G 3G6

  • Boehringer Ingelheim Investigational Site

    Gatineau, Quebec, J8P 7H2

  • 4 rue Robinson

    Granby, Quebec, J2G 8Z9

  • Boehringer Ingelheim Investigational Site

    Greenfield Park, Quebec, J4V 2G8

  • 169 Main Street East

    Grimsby, Ontario, L3M 1P3

  • 237 Barton Street East

    Hamilton, Ontario, L8L 2X2

  • HGH McMaster Clinic

    Hamilton, Ontario, L8L 2X2

  • Boehringer Ingelheim Investigational Site

    Hamilton, Ontario, L8M 1K7

  • 50 Charlton Avenue East

    Hamilton, Ontario, L8N 4A6

  • Boehringer Ingelheim Investigational Site

    Hamilton, Ontario, L8V 1C1

  • Boehringer Ingelheim Investigational Site

    Kelowna, British Columbia, V1W 3T1

  • Boehringer Ingelheim Investigational Site

    Kingston, Ontario, K7L 5E4

  • Boehringer Ingelheim Investigational Site

    Kitchener, Ontario, N2C 2N9

  • Boehringer Ingelheim Investigational Site

    La Malbaie, Quebec, G5A 1W7

  • Boehringer Ingelheim Investigational Site

    Laval, Quebec, H7V 3Y7

  • Boehringer Ingelheim Investigational Site

    Lethbridge, Alberta, T1J 0Z2

  • Boehringer Ingelheim Investigational Site

    London, Ontario, N5W 6A2

  • Boehringer Ingelheim Investigational Site

    London, Ontario, N6A 4G5

  • Haemolology Division

    London, Ontario, N6A 4G5

  • St Joseph's Healthcare

    London, Ontario, N6A 4V2

  • Boehringer Ingelheim Investigational Site

    London, Ontario, N6A 5R9

  • Boehringer Ingelheim Investigational Site

    Maple Ridge, British Columbia, V2X 2L5

  • Boehringer Ingelheim Investigational Site

    Markham, Ontario, L6B 1A1

  • Boehringer Ingelheim Investigational Site

    Medicine Hat, Alberta, T1A 4E4

  • Boehringer Ingelheim Investigational Site

    Mississauga, Ontario, L4W 1N2

  • 300-2338 Hurontario Street

    Mississauga, Ontario, L5B 1N1

  • Boehringer Ingelheim Investigational Site

    Mississauga, Ontario, L5M 2V8

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H1V 1X4

  • 2180 rue Fleury E

    Montreal, Quebec, H2B 1K3

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

    Montreal, Quebec, H2L 4M1

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H3H 1V4

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H3T 1E2

  • Hop du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H4N 2W2

  • Boehringer Ingelheim Investigational Site

    Mount Pearl, Newfoundland and Labrador, A1N 2C3

  • Boehringer Ingelheim Investigational Site

    New Glasgow, Nova Scotia, B2H 1K1

  • 220 Royal Avenue

    New Westminster, British Columbia, V3L 1H6

  • Boehringer Ingelheim Investigational Site

    Niagara Falls, Ontario, L2G 1J4

  • Boehringer Ingelheim Investigational Site

    North York, Ontario, M2K 2W2

  • Boehringer Ingelheim Investigational Site

    North York, Ontario, M2K 2Z3

  • Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • 1053 Carling Avenue

    Ottawa, Ontario, K1Y 4E9

  • Boehringer Ingelheim Investigational Site

    Ottawa, Ontario, K1Y 4G2

  • Boehringer Ingelheim Investigational Site

    Ottawa, Ontario, K1Y 4P6

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Boehringer Ingelheim Investigational Site

    Peterborough, Ontario, K9J 7H8

  • Boehringer Ingelheim Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • 1401-18 Rue

    Québec, Quebec, G1J 1Z4

  • Boehringer Ingelheim Investigational Site

    Richmond Hill, Ontario, L4C 2N9

  • Boehringer Ingelheim Investigational Site

    Saint John, New Brunswick, E2M 3W5

  • Boehringer Ingelheim Investigational Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • Boehringer Ingelheim Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7H 5M3

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7K 0H6

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7K 3H3

  • Boehringer Ingelheim Investigational Site

    Saskatoon, Saskatchewan, S7L 2W1

  • Boehringer Ingelheim Investigational Site

    Scarborough Village, Ontario, M1B 4Z8

  • 3001 12e ave Nord

    Sherbrooke, Quebec, J1H 5N4

  • 301-131 First Ave.

    Spruce Grove, Alberta, T7X 2Z8

  • Boehringer Ingelheim Investigational Site

    St-Jean Richelieu, Quebec, J3A 1C3

  • 262 Newfoundland Drive

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

  • 300 Prince Philip Drive

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

  • Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Boehringer Ingelheim Investigational Site

    Steinbach, Manitoba, R0A 2T3

  • Boehringer Ingelheim Investigational Site

    Surrey, British Columbia, V3V 1N1

  • Boehringer Ingelheim Investigational Site

    Sydney, Nova Scotia, B1P 1P3

  • Boehringer Ingelheim Investigational Site

    Thunder Bay, Ontario, P7E 1G6

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M1P 2T3

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M1S 4V5

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M1W 2R6

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M3C 3G8

  • 825 Coxwell Avenue

    Toronto, Ontario, M4C 3E7

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M4M 1J5

  • 600 Sherbourne Street, Suite 402

    Toronto, Ontario, M4X 1W4

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M5G 1E2

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • 76 Grenville Street

    Toronto, Ontario, M5S 1B2

  • Boehringer Ingelheim Investigational Site

    Trenton, Ontario, K8V 6H9

  • Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, V5Z 3J5

  • Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, V5Z 4E1

  • Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia, V6Z !Y6

  • Boehringer Ingelheim Investigational Site

    Victoria, British Columbia, V8R 6V4

  • Boehringer Ingelheim Investigational Site

    Wetaskiwin, Alberta, T9A 3N3

  • Boehringer Ingelheim Investigational Site

    Windsor, Ontario, N9A 1C9

  • 1095 Concordia Avenue

    Winnipeg, Manitoba, R2K 3S8

  • Boehringer Ingelheim Investigational Site

    York, Ontario, M9N 1J4

Other trials in Canada

About this study

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

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.

Read the 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

Being tested
Tiotropium (Spiriva®)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tiotropium (Spiriva®)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: after 48 weeks of treatment

Secondary outcomes (12)

  1. The change from baseline FEV1 at interim visits

    Measured: at Week 2, 11, 30 and 48

  2. The change from baseline FVC

    Measured: at Week 2, 11, 30 and 48

  3. The change from baseline FEV6 (at selected sites)

    Measured: at Week 2, 11, 30 and 48

  4. Incidence, severity and duration of COPD exacerbations

    Measured: at Week 2, 11, 30, 48 and 50

  5. Incidence and duration of hospitalisations due to COPD exacerbations

    Measured: at Week 2, 11, 30, 48 and 50

  6. Use of rescue medication (day-time and night-time) during treatment period

    Measured: week 1 until week 48

  7. Number of short courses of steroids/antibiotics during treatment period

    Measured: week 1 until week 48

  8. Assessment of COPD symptoms

    Measured: at Week 2, 11, 30 and 48

  9. Physician's Global Evaluation

    Measured: baseline and week 48

  10. Quality of life questionnaire (SGRQ)

    Measured: at week 30 and 48

  11. Adverse events

    Measured: 27 months

  12. Vital Signs

    Measured: 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2006 (estimated)
  2. Study startJan 2002
  3. Primary completionMay 2004
  4. Study completionMay 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
914 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277264
Sponsor's protocol ID
205.259
Status last verified
Nov 2013
First submitted
9 Jan 2006
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium (Spiriva®) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 96 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment. (time frame: after 48 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00277264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in