To determine the effect of bubbling therapy on asthma control in patients with difficult to treat asthma and dysfunctional breathing.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the percentage of patients with a clinically relevant
improvement in asthma control (ACQ) after treatment (week 6), defined as ΔACQ
>0.5.
Secondary outcome
Secondary endpoints are asthma quality of life (AQLQ), lung function (FEV1),
use of rescue inhalation medication, FeNO, Nijmegen hyperventilation Score,
Borg score for dyspnea and the vocal handicap index (VHI).
Background summary
Asthma is a chronic inflammatory disorder of the airways, which is
characterized by episodes of airway constriction, often provoked by different
stimuli (bronchial hyper reactivity). This results in symptoms such as chest
tightness, coughing, wheezing and chest pain. In a subset of asthma patients
symptoms persist despite optimal inhalation medication. In that case, it is
necessary to investigate other causal factors. In a proportion of this
difficult to treat asthma patients dysfunctional breathing plays a role.
Dysfunctional breathing is caused by chronic or recurrent changes in breathing
which can cause complaints of the lungs but also of the rest of the body. It is
an umbrella term that includes e.g. hyperventilation syndrome and vocal cord
dysfunction. Dysfunctional breathing affects 10% of the population. Symptoms
include shortness of breath, chest tightness, sighs and chest pain. Little is
known about dysfunctional breathing in asthma. It is often associated with
worse asthma control. Breathing training or voice exercises are recommended as
first-line treatment for people with dysfunctional breathing (with or without
asthma). Since a couple of years Vocal Bubbling Therapy (VBT) is used in voice
therapy in the Netherlands. By forming bubbles, low-frequency vibrations are
created in the hypo pharynx area. This could result in relaxation of the soft
tissue around the vocal cords and could be the reason of improvement of
symptoms in these patients. The aim of this study is to determine the effect of
bubbling therapy on asthma control in patients with coexisting asthma and
dysfunctional breathing.
Study objective
To determine the effect of bubbling therapy on asthma control in patients with
difficult to treat asthma and dysfunctional breathing.
Study design
Randomized controlled trial, based on the intention to treat principle.
Seventy-eight patients with difficult to treat asthma and dysfunctional
breathing will be randomized in two groups:
• Group A: usual asthma care (n=39)
• Group B: usual asthma care + consultation of the speech pathologist (4x), and
speech exercises using bubbling therapy (n=39)
Intervention
Group A: Usual care. Optimal treatment of asthma
Group B: As group A and Consultation of the speech pathologist and bubbling
therapy
Study burden and risks
Patients are expected to have individual treatment benefit from the study. The
study comprises 4 extra visits (see study design paragraph). All investigative
procedures are standard in the work-up of difficult-to-treat asthma and
dysfunctional breathing (e.g. spirometry, FeNO measurement, capillary blood
gas, laryngoscopy, symptom score and quality of life assessment). Both
speech-and bubbling therapy are non-invasive.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
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
*
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53240.101.15 |