Withdrawal of corticosteroids in COPD

Feasibility of the safe withdrawal of inhaled corticosteroids in patients with mild to moderate COPD prescribed outside guidelines (SWAP) - SWAP

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001876-31-GB

Enrollment

106

Registered

2016-08-05

Start date

2016-10-26

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: fluticasone propionate Pharmaceutical Form: Inhalation powder INN or Proposed INN: Flucticason CAS Number: 80474-14-2 Othe

Eligibility

Sex/Gender

All

Inclusion criteria

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) 400mcg/day or beclomethasone dipropionate >400mcg/day on most days for at least 3 months 3) aged =45 years 4) =65 years) yes F.1.3.1 Number of subjects for this age range 106

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Can high dose inhaled corticosteroids (ICS) be safely withdrawn from patients with COPD to whom they are prescribed outside guidelines?; Secondary Objective: 1. What are the perceptions of COPD patients with mild or moderate disease of the proposed withdrawal of high dose inhaled corticosteroids (ICS) prescribed outside guidelines? 2. Is the experimental withdrawal (randomisation to withdrawal or continuation) of high dose ICS acceptable to COPD patients with mild or moderate disease and to their general practices? 3. Are the investigations of the impact of the experimental withdrawal of high dose ICS acceptable to COPD patients with mild or moderate disease? 4. What is the impact of high dose ICS withdrawal in mild or moderate COPD on quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive and how are these outcomes distributed in mild or moderate COPD? 5. How safe is withdrawal of high dose ICS in mild or moderate COPD? 6. In the withdrawal of high dose ICS in mild or moderate COPD how many patients show evidence of benefit from the drugs? ;Primary end point(s): - Proportion of patients who attend the baseline interview who find the invitation to participate acceptable and are willing to submit to randomisation.;Timepoint(s) of evaluation of this end point: As above	—

Measure

Time frame

Main Objective: Can high dose inhaled corticosteroids (ICS) be safely withdrawn from patients with COPD to whom they are prescribed outside guidelines?; Secondary Objective: 1. What are the perceptions of COPD patients with mild or moderate disease of the proposed withdrawal of high dose inhaled corticosteroids (ICS) prescribed outside guidelines? 2. Is the experimental withdrawal (randomisation to withdrawal or continuation) of high dose ICS acceptable to COPD patients with mild or moderate disease and to their general practices? 3. Are the investigations of the impact of the experimental withdrawal of high dose ICS acceptable to COPD patients with mild or moderate disease? 4. What is the impact of high dose ICS withdrawal in mild or moderate COPD on quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive and how are these outcomes distributed in mild or moderate COPD? 5. How safe is withdrawal of high dose ICS in mild or moderate COPD? 6. In the withdrawal of high dose ICS in mild or moderate COPD how many patients show evidence of benefit from the drugs? ;Primary end point(s): - Proportion of patients who attend the baseline interview who find the invitation to participate acceptable and are willing to submit to randomisation.;Timepoint(s) of evaluation of this end point: As above

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: As above; Secondary end point(s): 1. proportion of patients who accept the investigations of the effect of high dose ICS withdrawal (acceptability of the main trial for which this is a feasibility study) 2. proportion of practices that agreed to participate 3. the distribution of the change in quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive between baseline and six months in patients from whom high dose ICS were withdrawn (allow the setting of sample sizes for the main trial) 4. frequency of exacerbations (assessing the safety of the main trial) 5. the proportion of participants in whom evidence of the effectiveness of high dose ICS was evident from a deterioration in quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive (assessing sample size for detection of ICS benefits for the main trial)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: As above; Secondary end point(s): 1. proportion of patients who accept the investigations of the effect of high dose ICS withdrawal (acceptability of the main trial for which this is a feasibility study) 2. proportion of practices that agreed to participate 3. the distribution of the change in quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive between baseline and six months in patients from whom high dose ICS were withdrawn (allow the setting of sample sizes for the main trial) 4. frequency of exacerbations (assessing the safety of the main trial) 5. the proportion of participants in whom evidence of the effectiveness of high dose ICS was evident from a deterioration in quality of life, lung function, exacerbation frequency, cellular and molecular biomarkers, and neural respiratory drive (assessing sample size for detection of ICS benefits for the main trial)

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Countries

United Kingdom

Contacts

Public ContactDr Patrick White

King's College London

patrick.white@kcl.ac.uk44207848 8679

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026