Withdrawal of Inhaled Corticosteroids in Primary Care Patients With COPD

NCT ID: NCT02691988

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-06-30

Brief Summary

Rationale: Because long-term use of ICS is associated with an increased likelihood of side-effects such as increased risk of pneumonia and loss of bone density, it is important to limit prescription of ICS to patients who have a clear indication for this treatment. In addition, avoiding unnecessary treatment with ICS could reduce the burden that chronic obstructive pulmonary disease (COPD) puts on healthcare budgets. The recently updated COPD guideline of the Dutch college of General Practitioners (NHG) emphasizes the importance of optimizing medical treatment for COPD patients with only limited room for the use of inhaled corticosteroids.

Objective: The objective of the study is to investigate whether discontinuation of inhaled corticosteroids (ICS) for patients without a clear indication for ICS according to current guidelines results in a reduction of ICS use without adverse health effects for the patients involved.

Study design: The study is a pragmatic, clustered, parallel group, non-inferiority trial in Dutch general practices with a follow-up of 26 weeks per patient.

Study population: 620 COPD patients with confirmed chronic airflow obstruction, aged ≥ 40 yrs who use ICS for at least the prior 6 months without a clear indication.

Intervention (if applicable): Guided ICS withdrawal in optimised COPD management. All study participants (of both study arms) will receive recommendations on optimal bronchodilator therapy and a personalized action plan to recognize symptom deterioration in an early stage.

Main study parameters/endpoints: Number of exacerbation-free weeks. Secondary study parameters: successful cessation of ICS, time to first exacerbation, number of moderate and severe exacerbations, health-related quality of life, health status, and pneumonias. Moreover, information on the process of care and costs will be collected.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Many COPD patients use ICS without a clear indication. Long-term use of ICS is associated with an increased likelihood of side-effects such as increased risk of pneumonia and loss of bone density and should be avoided in those who do not benefit from it. However, there is a small subgroup of COPD patients that have reduced numbers of exacerbations because of their ICS use and it is impossible to identify a priori the patients who this applies too. Therefore, it is important that the ICS discontinuation is guided to detect potential deteriorations early on.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ICS withdrawal

Guided ICS withdrawal combined with optimization of bronchodilator treatment

Group Type: EXPERIMENTAL

ICS withdrawal

Intervention Type: OTHER

Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG) and inhaled corticosteroids are withdrawn.

Usual care

Optimization of bronchodilator treatment

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG)

Interventions

ICS withdrawal

Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG) and inhaled corticosteroids are withdrawn.

Intervention Type: OTHER

Usual care

Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• COPD diagnosis in the medical record (ICPC code R95 or R91);
• Most recent spirometry result is less than three years old and shows a ratio of the Forced Expiratory Volume in 1 second (FEV1) to the Forced Vital Capacity (FVC) of less than 0.7, in short: FEV1/FVC ratio <0.7 (If no recent spirometry results are available, the patient will be scheduled for a diagnostic spirometric test);
• ICS treatment for at least the past 6 months;
• Accessible electronic medical record and prescription data history of at least one year;
• The subject's COPD is primarily managed by the general practioner (GP) (i.e., not by a chest physician); or if a subject's COPD is treated by a chest physician as well, the chest physician agrees with the invitation of the subject.
• Willing to provide written informed consent;
• Mentally competent.

Exclusion Criteria

• A spirometry test that has demonstrated airflow reversibility (i.e., post-bd FEV1 improvement of at least 12% and 200 ml compared to baseline and/or post-bd FEV1 improvement of 9% of the baseline FEV1 % predicted value) that preceded the initiation of ICS treatment;
• Diagnosis of asthma in the medical record (ICPC code R96);
• Allergic respiratory disease which has been confirmed by a positive skin prick test or specific immunoglobulin E (IgE) in serum as documented in the medical record, in combination with a documented history respiratory allergic symptoms;
• Two or more exacerbations in the previous 12 months that were treated with oral corticosteroids, antibiotics, or both; and/or required a visit to an emergency care facility or hospital admission;
• Use of oral corticosteroids on a regular basis (i.e., more than six weeks in the previous half year) for any reason;
• Currently participating in another intervention study that interferes with the current study;
• Has one or more serious other diseases that are likely to lead to study drop-out (e.g., diseases with limited life expectancy) or influence the study results; or
• Pregnancy or women who are trying to conceive a child;
• Unable to read or understand the Dutch language.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud University Medical Centre, Department of Primary and Community Care

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Tjard R Schermer, PhD

Role: CONTACT

Tjard.Schermer@radboudumc.nl

0031243614611

Lisette van den Bemt, PhD

Role: CONTACT

Lisette.vandenbemt@radboudumc.nl

0031243619588

Facility Contacts

Tjard R Schermer, PhD

Role: primary

tjard.schermer@radboudumc.nl

+31 24 3614611

Lisette van den Bemt, PhD

Role: backup

lisette.vandenbemt@radboudumc.nl

+31 24 3619588

Other Identifiers

NL52880.091.15

Identifier Type: -

Identifier Source: org_study_id