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Withdrawal of Inhaled Corticosteroids in Primary Care Patients With COPD (WHISPER)

24 febbraio 2016 aggiornato da: Radboud University Medical Center

Withdrawal of Inhaled Corticosteroids and the Possible Effect on Exacerbation Rate in Primary Care Patients With COPD

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

620

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
      • Nijmegen, Olanda, 6500 HB
        • Reclutamento
        • Radboud University Medical Centre, Department of Primary and Community Care
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Tjard R Schermer, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ICS withdrawal
Guided ICS withdrawal combined with optimization of bronchodilator treatment
Altro: 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.
Comparatore attivo: Usual care
Optimization of bronchodilator treatment
Altro: Usual care
Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of exacerbation-free weeks (EFWs)
Lasso di tempo: 6 months
Weeks in which the patient does not experience a worsening of his respiratory condition according to accepted symptom-based definitions of an exacerbation. This outcome is measured on a weekly basis with the Telephonic Exacerbation Assessment System (TEXAS)
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Successful ICS withdrawal
Lasso di tempo: 6 months
The proportion of patients with successful cessation of ICS, i.e. a period of 26 weeks after the withdrawal date without the occurrence of a moderate or severe exacerbation or reintroduction of ICS treatment.
6 months
Time to first exacerbation
Lasso di tempo: Max. 6 months
Time (in weeks) to first exacerbation will be calculated for all subjects. The definition for an exacerbation will be comparable to the definition used for EFWs. Information on time to first exacerbation will be collected using TEXAS.
Max. 6 months
Moderate and severe exacerbations
Lasso di tempo: 6 months
A moderate exacerbation is defined as prescription of a course of oral corticosteroids and/or antibiotics related to deterioration of COPD registered as episodes in the electronic patient record. A severe exacerbation is defined as a COPD-related ER visit and/or unscheduled COPD-related hospital admission.
6 months
Health status (CCQ)
Lasso di tempo: 6 months
Health status will be measured using the Clinical COPD Questionnaire (CCQ) which has been developed as a COPD specific health status measurement. CCQ questionnaires that are filled out at the start (t=0) and end of the study period (t = 26 weeks) will be used to evaluate the difference in change in CCQ score between the intervention and control groups.
6 months
Health-related quality of life (HRQoL)
Lasso di tempo: 6 months
Disease specific HRQoL will be assessed with the Short-form Chronic Respiratory Questionnaire (SF-CRQ) at baseline and 26 weeks of follow up.
6 months
General health state (EQ-5D-3L)
Lasso di tempo: 6 months
The EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) will be used to assess the general health state of subjects at the start and after 26 weeks.
6 months
Side effects of inhaled corticosteroids
Lasso di tempo: 6 months
Side effects of inhaled corticosteroids will be measured using the Inhaled Corticosteroids Questionnaire Short form (ICQ-S).
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Radboud University Medical Center

Collaboratori

Novartis
Boehringer Ingelheim

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2015

Completamento primario (Anticipato)

1 gennaio 2017

Completamento dello studio (Anticipato)

1 giugno 2017

Date di iscrizione allo studio

Primo inviato

22 febbraio 2016

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2016

Primo Inserito (Stima)

25 febbraio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 febbraio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 febbraio 2016

Ultimo verificato

1 febbraio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL52880.091.15

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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