Status:
COMPLETED
12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.
Detailed Description
Following an initial screening at the screening visit(Visit 1), patients enter a 2 week run-in period. Patients are allowed to take salbutamol (Ventoline, Diskus, 0.2 mg) prn as rescue medication and ...
Eligibility Criteria
Inclusion
- Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
- Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible.
- Patients 40 years of age or older without any restriction to sex.
- Patients who currently smoke or who are ex-smokers with a cigarette smoking history of \>10 pack-years.
- Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 \< 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1
Exclusion
- Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 \* 109/L) of the first determination at Visit 1
- Patients with known moderate or severe renal insufficiency.
- Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
- Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1.
- Patients who regularly use oxygen therapy.
- Patients with known active tuberculosis.
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
- Patients with a history of life threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
- Patients with known symptomatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
- Patients with known narrow-angle glaucoma.
Key Trial Info
Start Date :
March 11 2004
Trial Type :
INTERVENTIONAL
End Date :
July 25 2005
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00144196
Start Date
March 11 2004
End Date
July 25 2005
Last Update
December 5 2023
Active Locations (27)
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1
Boehringer Ingelheim Investigational Site
?tvidaberg, Sweden, 597 26
2
Boehringer Ingelheim Investigational Site
Alvesta, Sweden, 342 36
3
Boehringer Ingelheim Investigational Site
Boden, Sweden, 961 44
4
Boehringer Ingelheim Investigational Site
Dalum, Sweden, 520 25