Prevalence of Hyperventilation Syndrome in Difficult Asthma

Overview

Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.

Full Title of Study: “Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 18, 2016

Detailed Description

There is only one visit. During this visit, each patient will complete self-questionnaires like Nijmegen, Hospital Anxiety and Depression Scale(HAD), Short-Form 36(SF36), and Asthma Quality of Life Questionnaire (AQLQ), The participants will have baseline spirometry and fractional exhaled nitric oxide measured at expiratory flow of 50 mL/s (FENO50), blood gases at rest, an hyperventilation challenge and Cardiopulmonary Exercise Testing(CPET) to determine accurately the presence or not of chronic hyperventilation syndrome. The diagnosis is confirmed by two positive tests (Nijmegen, Hyperventilation challenge and blood gases) and the final decision of a medical committee. The first step is to determine the prevalence oh this syndrome in this specific population. The second step is to assess the sensitivity, the specificity, the false positive rate and the false negative rate of the different parameters measured during the tests.

Interventions

  • Other: Diagnostic of chronic hyperventilation syndrome
    • Nijmegen questionnaire, Hyperventilation challenge and blood gases

Arms, Groups and Cohorts

  • Experimental: Severe uncontrolled asthma
    • Asthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome.

Clinical Trial Outcome Measures

Primary Measures

  • Diagnostic of the hyperventilation syndrome
    • Time Frame: Up to 4 hours
    • value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET

Secondary Measures

  • Assess the diagnosis value of the nijmegen questionnaire.
    • Time Frame: Up to 4 hours
  • Assess the diagnosis value of the blod gases at rest.
    • Time Frame: up to 4 hours
  • Assess the diagnosis value of the hyperventilation challenge.
    • Time Frame: Up to 4 hours
  • Assess the diagnosis value of the CPET.
    • Time Frame: Up to 4 hours

Participating in This Clinical Trial

Inclusion Criteria

  • men and women, – aged more than 18, – non smokers for two years or longer, less than 10 pack/years smoking history, – physician-diagnosed asthma, – uncontrolled asthma with Asthma control test (ACT) < 18, – historical of FEV1 reversibility, – daily inhaled steroids treatment by at least 2000microg eq beclomethasone, – Forced expiratory volume in 1 second (FEV1) > 50% predicted value Exclusion Criteria:

  • other chronic pulmonary disease, – vocal cord dysfunction, – pregnancy, – Participation in another interventional research trial, – unable to provide consent, – asthma exacerbation within the last 4 weeks

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gilles Garcia, MD, PhD, Principal Investigator, Assistance Publique Hôpitaux de Paris – Bicêtre Hospital

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