Investigation of steroid responsiveness in patients with chronic obstructive pulmonary disease

Not Applicable

Completed

Conditions: Chronic obstructive pulmonary disease
Respiratory
Chronic obstructive pulmonary disease, unspecified

Registration Number: ISRCTN11017699

Lead Sponsor: niversity Hospital Basel

Brief Summary: 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37385657/ (added 25/07/2023) 2024 Results article in https://doi.org/10.1007/s00408-024-00680-8 (added 22/04/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38812021/ (added 30/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 190

Inclusion Criteria

1. Age =40 years
2. COPD, as defined by the GOLD Guidelines and categorization in groups B-D
3. No acute exacerbation of COPD or any respiratory infection requiring medical attention or leading to a change in medication within the last 4 weeks
4. Unchanged respiratory medication regimen within the last 8 weeks
5. At least one exacerbation in the previous year
6. Current or ex-smokers with smoking history of = 10 pack-years
7. Willingness to participate in a longitudinal, cohort study
8. Capability to provide written informed consent

Exclusion Criteria

1. Rapid fatal disease (with life expectancy less than 3 months)
2. Pulmonary condition other than COPD as the main respiratory disease
3. Current diagnosis of bronchial asthma
4. Severe immune-suppression including HIV, organ transplantation, ongoing chemotherapy for cancer
5. Pregnancy or breastfeeding
6. Chronic use of oral steroids (> 10 mg per day) for COPD
7. Intolerance or contraindication to aclidinium, formoterol or budesonide

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the differences in the mean decrease of post-bronchodilator FEV1 in milliliters measured using a spirometer at 12 months, between patients with low (=20%) and high (>20%) ASMC area and according to whether they received ICS or not

Secondary Outcome Measures

Name	Time	Method
Immediately after the run-in phase, at 3, 6, 9 and 12 months after randomization to compare changes in:<br>1. Modified Medical Research Council (MMRC) dyspnea scale<br>2. COPD assessment test (CAT)<br>3. Health-related quality of life, measured using SF-36, SGRQ<br>4. Pre and post bronchodilator body plethysmography/DLCO<br>5. Expiratory FeNO<br>6. Single and multiple-breath N2 wash-out<br>7. Forced impulse oscillometry<br>8. 6-minute walking distance (6MWD)<br>9. Movement patterns, measured using accelerometry<br>10. Therapy-related side effects (oral candidiasis, tachycardia, tremor, hoarseness, pneumonia)<br>11. Exacerbations rate<br>12. Serum biomarkers<br>between patients with low (=20%) and high (>20%) ASMC area and according to whether they received ICS or not