Withdrawal of corticosteroids in COPD

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2016-001876-31-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

1) known diagnosis of mild or moderate COPD (forced expiratory volume in first second (FEV1) =50% predicted and FEV1/forced vital capacity (FVC) <0.7) obtained from spirometry within the past 12 months and confirmed at interview
2) prescribed and have used high-dose ICS (alone or in combination with a long-acting bronchodilator) at a dose of fluticasone propionate =250mcg/day, fluticasone furoate =92mcg/day, budesonide >400mcg/day or beclomethasone dipropionate >400mcg/day on most days for at least 3 months
3) aged =45 years
4) <2 exacerbations in the previous year and no admissions to hospital with an exacerbation since the diagnosis of COPD was made
5) BMI of less than 35.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 106

Exclusion Criteria

1) a history (stated in the patient record) of asthma, lung cancer or breathlessness secondary to cardiac disease
2) current severe mental illness (severe depression or psychosis)
3) current alcohol dependence (patient report or entry in medical record as alcohol dependence or alcohol induced disease)
4) Patients diagnosed with dementia
5) Patients who use continuous oral corticosteroids
6) Patients who are unwilling or unable to follow the study protocol
7) Patients who are participating in another clinical trial
8) Pregnant females or females of childbearing age not using effective contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified