Prevalence of Hyperventilation Syndrome in Difficult Asthma (PRESH)
Primary Purpose
Difficult Asthma, Severe Persistent Asthma, Hyperventilation Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic of chronic hyperventilation syndrome
Sponsored by
About this trial
This is an interventional diagnostic trial for Difficult Asthma focused on measuring difficult asthma, hyperventilation syndrome, prevalence
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
Sites / Locations
- Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Severe uncontrolled asthma
Arm Description
Asthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome.
Outcomes
Primary Outcome Measures
Diagnostic of the hyperventilation syndrome
value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET
Secondary Outcome Measures
Assess the diagnosis value of the nijmegen questionnaire.
Assess the diagnosis value of the blod gases at rest.
Assess the diagnosis value of the hyperventilation challenge.
Assess the diagnosis value of the CPET.
Full Information
NCT ID
NCT01862289
First Posted
May 22, 2013
Last Updated
April 27, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01862289
Brief Title
Prevalence of Hyperventilation Syndrome in Difficult Asthma
Acronym
PRESH
Official Title
Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 28, 2013 (Actual)
Primary Completion Date
October 18, 2016 (Actual)
Study Completion Date
October 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Asthma, Severe Persistent Asthma, Hyperventilation Syndrome
Keywords
difficult asthma, hyperventilation syndrome, prevalence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe uncontrolled asthma
Arm Type
Experimental
Arm Description
Asthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome.
Intervention Type
Other
Intervention Name(s)
Diagnostic of chronic hyperventilation syndrome
Other Intervention Name(s)
Exploration to sarch a chronic hyperventilation syndrome
Intervention Description
Nijmegen questionnaire, Hyperventilation challenge and blood gases
Primary Outcome Measure Information:
Title
Diagnostic of the hyperventilation syndrome
Description
value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET
Time Frame
Up to 4 hours
Secondary Outcome Measure Information:
Title
Assess the diagnosis value of the nijmegen questionnaire.
Time Frame
Up to 4 hours
Title
Assess the diagnosis value of the blod gases at rest.
Time Frame
up to 4 hours
Title
Assess the diagnosis value of the hyperventilation challenge.
Time Frame
Up to 4 hours
Title
Assess the diagnosis value of the CPET.
Time Frame
Up to 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Garcia, MD, PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
City
Le Kremlin-bicetre
ZIP/Postal Code
94 275
Country
France
12. IPD Sharing Statement
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Prevalence of Hyperventilation Syndrome in Difficult Asthma
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