Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

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