Bubbling therapy for dysfunctional breathing in difficult to treat asthma - a pilot study

Recruiting

Conditions: asthma
dysfunctional breathing
10006436

Registration Number: NL-OMON42399

Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 78

Inclusion Criteria

• Difficult to treat asthma
And either/or
o Chronic hypocapnia (pCO2 < 4.7 kPa and HCO3- < 23 mEq/L)
o Clinical signs of vocal cord dysfunction with PVCDI > 4
AND
• No anatomical or mechanical abnormalities in the naso-oro-hypo-pharyngeal tract

Exclusion Criteria

• Current smoking or more than 10 PY in history
• Recent exacerbation of asthma or airway infection (< 6 weeks)
• Anatomical abnormalities of the upper/lower airway tract
• Inability to perform a reproducible lung function test
• Another untreated causative factor for uncontrolled asthma
• FEV1 post-bronchodilator < 80% of predicted.
• FeNO > 50 ppb
*

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the percentage of patients with a clinically relevant<br /><br>improvement in asthma control (ACQ) after treatment (week 6), defined as ΔACQ<br /><br>>0.5. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are asthma quality of life (AQLQ), lung function (FEV1),<br /><br>use of rescue inhalation medication, FeNO, Nijmegen hyperventilation Score,<br /><br>Borg score for dyspnea and the vocal handicap index (VHI). </p><br>