Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-04-30

Brief Summary

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Ten percent of infants are prescribed short-acting bronchodilators (i.e. salbutamol) for wheezing every year, yet evidence to support this treatment in children younger than two years old is scarce. The aim of this study is to evaluate the effectiveness and safety of salbutamol for treatment of wheezing in young children who present to their primary care physician.

In this study, the investigators will compare the effect of a 7-day treatment with salbutamol to the effect of 7-day treatment with a placebo. The main effect will be measured by evaluating a parent-reported symptom score. Additionally, the investigators will look at the presence of wheeze after 5 days, time to recovery, adverse events, healthcare utilisation, medication prescriptions, cost-effectiveness, and parent satisfaction with treatment.

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Detailed Description

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BACKGROUND: Worldwide, 30% of all infants and young children experience an episode of wheezing (Matricaldi et al. 2008; Mallol at al. 2010; Martinez et al. 1995). Currently, there is no evidence to underpin the management of these children. National Belgian and Dutch primary care professional guidelines propose 'a trial of treatment' with short acting bronchodilators (i.e. salbutamol) for wheezing children below the age of six years and to evaluate treatment effect after 1 to 2 weeks, but convincing evidence is lacking (Chavasse et al. 2002).

The effect of salbutamol has been studied well in children with proven asthma and is considered the first-line treatment in all patients in international asthma guidelines. However, trial findings of children with asthma are not applicable to primary care infants and young children with acute wheeze for several reasons; the anatomy and physiology in younger children differs significantly from those in older children and many infants and young children with an acute episode of wheezing do not experience further wheezing episodes later in life. As a result, it is at present unclear whether salbutamol inhalation therapy confers any benefit in young children who wheeze.

OBJECTIVE: To evaluate the (cost-)effectiveness of salbutamol inhalations (4x200μg for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing.

DESIGN: A primary care based, randomised, placebo-controlled, multicentre, parallel group trial in 40 general practices and community paediatric practices in Belgium and the Netherlands.

Conditions

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Wheezing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individually randomised, placebo-controlled, multicentre, parallel group trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Salbutamol

Salbutamol inhalation 4x200ug daily for 7 days, delivered using a Babyhaler

Group Type ACTIVE_COMPARATOR

Salbutamol

Intervention Type DRUG

Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.

Placebo

Placebo 4 x 2 inhalations daily for 7 days, delivered using a Babyhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.

Interventions

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Salbutamol

Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.

Intervention Type DRUG

Placebo

The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.

Intervention Type DRUG

Other Intervention Names

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Ventolin β2-adrenoceptor agonist Bronchodilator Salbutamol sulfate Mock inhaler

Eligibility Criteria

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Inclusion Criteria

* Presenting to their primary care physician because of wheezing as confirmed by clinical examination (chest auscultation)
* A baseline score of 7 or higher on a parent-reported respiratory symptom score

Exclusion Criteria

* Prematurity (\<37 weeks)
* Major congenital malformations
* Pre-existing pulmonary disease as diagnosed by a paediatrician
* Continuous use of inhalation medication
* Physician visit because of wheezing in previous two weeks
* Use of inhalation medication in the previous two weeks
* Wheezing as a result of upper airway obstruction (i.e. laryngitis subglottica/pseudocroup)
* Severe illness requiring inhalation medication, prescription of antibiotics, or hospital referral during the consultation of inclusion

Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No