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OpenTrials
Completed

NCT Number: NCT00239460

Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Attn: William C. Bailey, M.D., Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
  • Smoking history greater than or equal to 10 pack years
  • Not history of clinical diagnosis of asthma and/or atopy
  • A history of thoracotomy with pulmonary resection
  • Patients requiring the use of supplemental oxygen therapy for >12 hours per day
  • Chronic use of systemic corticosteroids in an unstable daily dose
  • Patients with a recent history of myocardial infarction
  • A known hypersensitivity to anticholinergic drugs

Treatment and study plan

Tiotropium

Drug

Primary outcomes

  1. Trough FEV1 after 12 weeks of treatment

    Time frame: 12 weeks

Secondary outcomes

  1. Trough FEV1 at Visit 3

    Time frame: week 8

  2. Trough FVC at Visits 3 and 4

    Time frame: week 8 and week 12

  3. FEV1 and FVC 90 min post study drug inhalation at all visits

    Time frame: 90 minutes post-medication

  4. Use of rescue medication

    Time frame: 12 weeks

  5. Patient's Global Evaluation

    Time frame: week 8 and week 12

  6. Physician's Global Evaluation

    Time frame: week 8 and week 12

  7. Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4

    Time frame: week 8 and week 12

  8. Adverse events

    Time frame: 12 weeks

  9. Vital signs

    Time frame: week 8 and week 12

  10. Physical Exam

    Time frame: week 12

  11. 12-lead ECG

    Time frame: week 8 and week 12

  12. 24-hour holter ECG monitoring

    Time frame: week 8 and week 12

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).

Important dates

Study start
2003
Primary completion
2004
First posted
Oct 17, 2005
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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