Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: tiotropium inhalation; Drug: salmeterol xinafoate; Drug: placebo matched for fluticasone propionate; Drug: fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975195

2007-002522-29 (EudraCT Number)

352.2046

Details and patient eligibility

About

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.

Enrollment: 2,488 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,488 participants in 2 patient groups

fluticasone high dose

Experimental group

Description:

fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate

Treatment:

Drug: salmeterol xinafoate

Drug: fluticasone propionate

Drug: tiotropium inhalation

fluticasone medium & low doses

Experimental group

Description:

fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate

Treatment:

Drug: placebo matched for fluticasone propionate

Drug: salmeterol xinafoate

Drug: fluticasone propionate

Drug: tiotropium inhalation