Prevalence of Hyperventilation Syndrome in Difficult Asthma (PRESH)

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Persistent Asthma; Hyperventilation Syndrome; Difficult Asthma
• Intervention / Treatment: Other: Diagnostic of chronic hyperventilation syndrome

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Kremlin-bicetre, France, 94 275
    • Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Diagnostic of chronic hyperventilation syndrome; Nijmegen questionnaire, Hyperventilation challenge and blood gases; Other Names: Exploration to sarch a chronic hyperventilation syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Gilles Garcia, MD, PhD, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2013
• Primary Completion (ACTUAL): October 18, 2016
• Study Completion (ACTUAL): October 18, 2016

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (ESTIMATE): May 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: prevalence; difficult asthma; hyperventilation syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Disease; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Syndrome; Asthma; Hyperventilation
• Other Study ID Numbers: P110904; CRC 11093 (OTHER: APHP - Clinical research department)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No