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Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274573
First received: January 9, 2006
Last updated: November 20, 2013
Last verified: November 2013

January 9, 2006
November 20, 2013
March 2002
October 2002   (final data collection date for primary outcome measure)
  • Change from baseline in trough FEV1 (Forced expiratory volume in one second) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in FEV1 2 hours post inhalation [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
Two primary endpoints were examined: o change from baseline in trough (pre does) FEV1 after 12 weeks of treatment, o change from baseline in FEV1 2 hours post inhalation after 12 weeks of treatment
Complete list of historical versions of study NCT00274573 on ClinicalTrials.gov Archive Site
  • Change from baseline in FEV1 2 hours post inhalation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation [ Time Frame: Day 1 and 85 ] [ Designated as safety issue: No ]
  • Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation [ Time Frame: Day 1 and 85 ] [ Designated as safety issue: No ]
  • Number of patients having a COPD exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients being hospitalised due to a COPD exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of COPD exacerbations per patient [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number hospitalisations due to COPD exacerbations per patient [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of COPD exacerbations per patient [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of hospitalisations due to a COPD exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in FEV1 two hours post first inhalation at the beginning of the study, as well as changes from baseline at trough and 2 hours post inhalation in FVC, IVC; exazerbations; adverse events
Not Provided
Not Provided
 
Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

The primary objective of this study is to investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium bromide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1639
Not Provided
October 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:

    • Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %.
    • Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
  2. Male or female patients 40 years of age or older.
  3. Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
  4. Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol.
  5. Patients must be able to inhale medication from the HandiHaler.
  6. All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications.

Exclusion Criteria:

  1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
  2. Patients with a recent history (i.e., one year or less) of myocardial infarction.
  3. Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
  4. Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
  5. Patients with known active tuberculosis.
  6. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
  7. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
  8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
  9. Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
  10. Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week 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 prostate hypertrophy or bladder neck obstruction.
  13. Patients with known narrow-angle glaucoma.
  14. Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
  15. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
  16. Patients with a history of asthma, allergic rhinitis or atopy.
  17. Patients with a history of and/or active significant alcohol or drug abuse.
  18. Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00274573
205.257
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim KG
Boehringer Ingelheim
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP