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12 Week Efficacy of Tiotropium(S Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144196
  Purpose

To show that treatment with tiotropium(Spiriva) inhalation capsules (18 ?g q.d.) via HandiHaler? improves lung function in patients with mild COPD according to Swedish guidelines.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium (Spiriva)
Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Tiotropium Tiotropium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A 12-Week, Double-Blind,Randomised, Parallel-Group,, Multi-Centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment.

Estimated Enrollment: 250
Estimated Study Completion Date: July 2005
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 have to record their daily use of it on the Patient's Diary. Patients who meet all inclusion and none of the exclusion criteria at the check at Visit 2 will be randomised thereafter into the randomised treatment period of the study during which they will receive either tiotropium(Spiriva) or placebo in blinded fashion.

On Day 0 (Visit 2), the first administration of blinded study medication (tiotropium(Spiriva) or matching placebo) will be performed at the study site, after a pre-dose pulmonary function test (PFT) has been carried out. First administration of blinded study medication will be monitored by the investigator. Post dose PFTs will be performed at 30 min, 1 and 2 hours.

On Days 1 to 83 except Day 14, the blinded study medication will be self-administered by the patients at home. The patients will inhale one capsule (tiotropium)(Spiriva) or matching placebo) using the HandiHaler device once daily in the morning. The morning dose of the blinded study medication should be taken at approximately the same time each morning between 7:00 a.m. and 10:00 a.m.

At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes, 1 and 2 hours

Study Hypothesis:

The rationale of the study is to show that treatment with tiotropium (Spiriva) 18 ?g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines, i.e., a post-bronchodilator FEV1 < 60% of predicted normal and FEV1 < 70% of FVC.

Comparison(s):

One group will be treated with inhalation powder capsules of tiotropium (Spiriva), 18 micrograms once daily. The other group will be treated with matching placebo. Randomisation is 1:1

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
  2. 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.
  3. Patients 40 years of age or older without any restriction to sex.
  4. Patients who currently smoke or who are ex-smokers with a cigarette smoking history of >10 pack-years.
  5. 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 Criteria:

  1. 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
  2. Patients with known moderate or severe renal insufficiency.
  3. Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
  4. 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.
  5. Patients who regularly use oxygen therapy.
  6. Patients with known active tuberculosis.
  7. Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
  8. Patients with a history of life threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis.
  9. Patients who have undergone thoracotomy with pulmonary resection.
  10. 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).
  11. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
  12. 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.
  13. Patients with known narrow-angle glaucoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144196

Locations
Sweden
Boehringer Ingelheim Investigational Site
Uppsala, Sweden, 754 27
KvartersAkuten, Timmermansgatan 26
Lule?, Sweden, 972 31
Halsocentralen, Hans?kervagen 1A
Stugun, Sweden, 830 76
Boehringer Ingelheim Investigational Site
Sunne, Sweden, 686 22
Alno V?rdcentral, Raholmsvagen 24
Sundsvall, Sweden, 865 31
Boehringer Ingelheim Investigational Site
Hasselby, Sweden, 165 55
Boehringer Ingelheim Investigational Site
Stockholm, Sweden, 114 86
Boehringer Ingelheim Investigational Site
Motala, Sweden, 591 36
Boehringer Ingelheim Investigational Site
?tvidaberg, Sweden, 597 26
Boehringer Ingelheim Investigational Site
Goteborg, Sweden, 411 53
Boehringer Ingelheim Investigational Site
Dalum, Sweden, 520 25
Boehringer Ingelheim Investigational Site
Ulricehamn, Sweden, 523 26
Boehringer Ingelheim Investigational Site
Kalmar, Sweden, 393 50
Boehringer Ingelheim Investigational Site
Gislaved, Sweden, 332 30
Boehringer Ingelheim Investigational Site
Kristianstad, Sweden, 291 38
Boehringer Ingelheim Investigational Site
Helsingborg, Sweden, 254 43
Boehringer Ingelheim Investigational Site
Hollviken, Sweden, 236 51
Boehringer Ingelheim Investigational Site
Skarholmen, Sweden, 127 37
Jakobsbergs sjukhus, Birgittavagen 4
Jarfalla, Sweden, 17731
Boehringer Ingelheim Investigational Site
Karlstad, Sweden, 65224
Boehringer Ingelheim Investigational Site
Helsingborg, Sweden, 254 67
Boehringer Ingelheim Investigational Site
Linkoping, Sweden, 581 88
Boehringer Ingelheim Investigational Site
Lund, Sweden, 221 85
Boehringer Ingelheim Investigational Site
Boden, Sweden, 961 44
Boehringer Ingelheim Investigational Site
Lule?, Sweden, 971 89
Boehringer Ingelheim Investigational Site
Goteborg, Sweden, 416 65
Boehringer Ingelheim Investigational Site
Alvesta, Sweden, 342 36
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Sweden AB
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: 205.281
Study First Received: September 2, 2005
Last Updated: November 28, 2008
ClinicalTrials.gov Identifier: NCT00144196  
Health Authority: Sweden: Medical Products Agency

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009