Prevalence of Hyperventilation Syndrome in Difficult Asthma

NCT ID: NCT01862289

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-28
• Study Completion Date: 2016-10-18

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.

Conditions

Difficult Asthma; Severe Persistent Asthma; Hyperventilation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diagnostic of chronic hyperventilation syndrome

Intervention Type: OTHER

Nijmegen questionnaire, Hyperventilation challenge and blood gases

Interventions

Diagnostic of chronic hyperventilation syndrome

Nijmegen questionnaire, Hyperventilation challenge and blood gases

Intervention Type: OTHER

Other Intervention Names

Exploration to sarch a chronic hyperventilation syndrome

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Garcia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Locations

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

CRC 11093

Identifier Type: OTHER

Identifier Source: secondary_id

P110904

Identifier Type: -

Identifier Source: org_study_id