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
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium bromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1639
Study Start Date: March 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274573

  Show 177 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim KG
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274573     History of Changes
Other Study ID Numbers: 205.257
Study First Received: January 9, 2006
Last Updated: November 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bromides
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 14, 2014