Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
The primary efficacy endpoint is time to first COPD exacerbation. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00975195 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 10, 2009)
Breathlessness, exercise endurance, health related quality of life Number and severity of COPD exacerbations Changes in inflammatory markers [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEInhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Official Title  ICMJEInhaled Corticosteroid Withdrawal Study
Brief Summary

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Tiotropium
  • Drug: Salmeterol
  • Drug: Fluticasone

Recruitment Information

Estimated Enrollment  ICMJE2192
Completion Date 
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female aged 40 years or more
  2. Severe to very severe chronic obstructive pulmonary disease (COPD)
  3. Current or ex-smoker with smoking history of at least 10 pack years
  4. At least one documented exacerbation of COPD in previous year

Exclusion Criteria:

  1. Significant diseases other than COPD; significant alcohol or drug abuse
  2. Current clinical diagnosis of asthma requiring steroid treatment
  3. History of thoracotomy with pulmonary resection
  4. Regular use of daytime oxygen
  5. Recent history (within 3 months) of myocardial infarction
  6. Recent (within 6 weeks) respiratory infection or COPD exacerbation
  7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of 5milligram / day
  8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring intervention
  9. Recent (within 1 year) hospitalisation for cardiac failure
  10. Malignancy requiring chemotherapy or radiotherapy
  11. Clinical diagnosis of bronchiectasis
  12. Pregnant or nursing women
  13. Known hypersensitivity to study drugs
  14. Current or recent (within 30 days) participation in another clinical study
  15. Current participation in or recent completion (within 4 weeks) of a pulmonary rehabiliation program
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study
Location Countries  ICMJEAustralia,   Belgium,   Brazil,   Bulgaria,   China,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   New Zealand,   Philippines,   Poland,   Russian Federation,   South Africa,   Spain,   Switzerland,   Taiwan,   Tunisia,   Turkey,   Ukraine,   United Kingdom

Administrative Information

Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE352.2046, EUDRACT2007-002522-29
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals