Spiriva® Assessment of FEV1 (SAFE)

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Tiotropium (Spiriva®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277264

205.259

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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