Prevalence of Hyperventilation Syndrome in Difficult Asthma

Severe Persistent Asthma Clinical Trial

— PRESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862289
• Other study ID #: P110904
• Secondary ID: CRC 11093
• Status: Completed
• Phase: N/A
• Start date: April 28, 2013
• Est. completion date: October 18, 2016

Study information

• Verified date: April 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 18, 2016
• Est. primary completion date: October 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Difficult Asthma
• Hyperventilation
• Hyperventilation Syndrome
• Severe Persistent Asthma
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital	Le Kremlin-bicetre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic of the hyperventilation syndrome	value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET	Up to 4 hours
Secondary	Assess the diagnosis value of the nijmegen questionnaire.		Up to 4 hours
Secondary	Assess the diagnosis value of the blod gases at rest.		up to 4 hours
Secondary	Assess the diagnosis value of the hyperventilation challenge.		Up to 4 hours
Secondary	Assess the diagnosis value of the CPET.		Up to 4 hours