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Completed

NCT Number: NCT01862289

Prevalence of Hyperventilation Syndrome in Difficult Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, 94 275, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic of chronic hyperventilation syndrome

Other

Nijmegen questionnaire, Hyperventilation challenge and blood gases

Other names: Exploration to sarch a chronic hyperventilation syndrome

Primary outcomes

  1. 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 outcomes

  1. Assess the diagnosis value of the nijmegen questionnaire.

    Time frame: Up to 4 hours

  2. Assess the diagnosis value of the blod gases at rest.

    Time frame: up to 4 hours

  3. Assess the diagnosis value of the hyperventilation challenge.

    Time frame: Up to 4 hours

  4. Assess the diagnosis value of the CPET.

    Time frame: Up to 4 hours

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment

Acronym: PRESH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 24, 2013
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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