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Prevalence of Hyperventilation Syndrome in Difficult Asthma (PRESH)

This study is currently recruiting participants.
Verified September 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862289
First Posted: May 24, 2013
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention
Difficult Asthma Severe Persistent Asthma Hyperventilation Syndrome Other: Diagnostic of chronic hyperventilation syndrome

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Diagnostic of the hyperventilation syndrome [ Time Frame: Up to 4 hours ]
    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. [ Time Frame: Up to 4 hours ]
  • Assess the diagnosis value of the blod gases at rest. [ Time Frame: up to 4 hours ]
  • Assess the diagnosis value of the hyperventilation challenge. [ Time Frame: Up to 4 hours ]
  • Assess the diagnosis value of the CPET. [ Time Frame: Up to 4 hours ]

Estimated Enrollment: 150
Study Start Date: April 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Exploration to sarch a 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862289


Contacts
Contact: Gilles Garcia, MD, PhD +33 (1) 45 21 36 63 gilles.garcia@bct.aphp.fr

Locations
France
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital Recruiting
Le Kremlin-bicetre, France, 94 275
Contact: Gilles Garcia, MD, PhD    +33 (1) 45 21 36 63    gilles.garcia@bct.aphp.fr   
Principal Investigator: Gilles Garcia, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gilles Garcia, MD, PhD Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01862289     History of Changes
Other Study ID Numbers: P110904
CRC 11093 ( Other Identifier: APHP - Clinical research department )
First Submitted: May 22, 2013
First Posted: May 24, 2013
Last Update Posted: October 10, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
difficult asthma
hyperventilation syndrome
prevalence

Additional relevant MeSH terms:
Asthma
Syndrome
Hyperventilation
Disease
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms