Prevalence of Hyperventilation Syndrome in Difficult Asthma

NCT01862289 | Completed

• 2 other identifiers: P110904CRC 11093
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Asthma; Severe Persistent Asthma; Hyperventilation Syndrome

Keywords

difficult asthma; hyperventilation syndrome; prevalence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Severe uncontrolled asthma

EXPERIMENTAL

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

Interventions

Diagnostic of chronic hyperventilation syndrome OTHER

Nijmegen questionnaire, Hyperventilation challenge and blood gases

Also known as: Exploration to sarch a chronic hyperventilation syndrome

Severe uncontrolled asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

Le Kremlin-Bicêtre, 94 275, France

Location

Study Officials

• Gilles Garcia, MD, PhD

  Assistance Publique Hôpitaux de Paris - Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 24, 2013
• Study Start: April 28, 2013
• Primary Completion: October 18, 2016
• Study Completion: October 18, 2016
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

FR (1)