Clinical trial NCT01862289: Prevalence of Hyperventilation Syndrome in Difficult Asthma
Official title: Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Asthma
Severe Persistent Asthma
Hyperventilation Syndrome
Keywords: difficult asthma
hyperventilation syndrome
prevalence
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic of the hyperventilation syndrome
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Assess the diagnosis value of the nijmegen questionnaire.
timeFrame: Up to 4 hours
measure: Assess the diagnosis value of the blod gases at rest.
timeFrame: up to 4 hours
measure: Assess the diagnosis value of the hyperventilation challenge.
timeFrame: Up to 4 hours
measure: Assess the diagnosis value of the CPET.
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Le Kremlin-bicetre
country: France
facility: Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
name: Gilles Garcia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: