Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00975195
First received: September 10, 2009
Last updated: November 21, 2013
Last verified: November 2013

September 10, 2009
November 21, 2013
February 2009
July 2013   (final data collection date for primary outcome measure)
Time to first moderate or severe on-treatment COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is time to first COPD exacerbation. [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00975195 on ClinicalTrials.gov Archive Site
  • Number of moderate or severe on-treatment COPD exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Severity of on-treatment COPD exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment exercise capacity measured by six-minute walk test (6-MWT) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores. [ Time Frame: up tp 52 weeks ] [ Designated as safety issue: No ]
  • Changes in on-treatment serum biomarkers adiponectin, leptin, C-reactive protein, IL-6, IL-8, TNF-α, fibrinogen, sICAM-1, serum amyloid A and B-type BNP, procalcitonin [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in sputum cellularity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one moderate or severe on-treatment COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first severe on-treatment COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of severe on-treamtent COPD exacerbation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one severe on-treatment COPD exacerbation. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to first on-treatment COPD exacerbation (any severity). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Number of on-treatment COPD exacerbations (any severity). [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one on-treatment COPD exacerbation (any severity) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes in on-treatment physical health status as determined by body mass index (BMI) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment BODE index [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment lung function (FEV1, FVC and and peak expiratory flow rate (PEFR)) as measured by home based spirometry [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Changes in on-treatment physician global evaluation [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Change in total lung capacity (TLC), functional residual capacity (FRC) and inspiratory capacity (IC) as determined by body plethysmograph [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Changes in exhaled nitric oxide (NO). [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Changes in arterialised blood gases (PaO2 and PaCO2). [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Changes in diffusing capacity of carbon monoxide (DLCO). [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Major Adverse Cardiovascular Events (MACE) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Fatal MACE [ Time Frame: up uo 52 weeks ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Pneumonia [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Vital status [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
Breathlessness, exercise endurance, health related quality of life Number and severity of COPD exacerbations Changes in inflammatory markers [ Time Frame: 48 weeks ]
Not Provided
Not Provided
 
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Tiotropium +salmeterol+ fluticasone high dose
  • Drug: Tiotropium+salmeterol+ fluticasone high,med, low, placebo
  • Active Comparator: Fluticasone maintenance
    Intervention: Drug: Tiotropium +salmeterol+ fluticasone high dose
  • Placebo Comparator: Fluticasone withdrawal
    Intervention: Drug: Tiotropium+salmeterol+ fluticasone high,med, low, placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2488
July 2013
July 2013   (final data collection date for primary outcome measure)

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 rehabilitation program
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Bulgaria,   China,   Denmark,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   New Zealand,   Philippines,   Poland,   Russian Federation,   South Africa,   Spain,   Taiwan,   Tunisia,   Turkey,   Ukraine,   United Kingdom
 
NCT00975195
352.2046, 2007-002522-29
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2013

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