Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial (KIWI)
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|ClinicalTrials.gov Identifier: NCT04584034|
Recruitment Status : Not yet recruiting
First Posted : October 12, 2020
Last Update Posted : February 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Wheezing||Drug: Salbutamol Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Individually randomised, placebo-controlled, multicentre, parallel group trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Active Comparator: Salbutamol
Salbutamol inhalation 4x200ug daily for 7 days, delivered using a Babyhaler
Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.
Placebo Comparator: Placebo
Placebo 4 x 2 inhalations daily for 7 days, delivered using a Babyhaler
The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.
Other Name: Mock inhaler
- Course of the parent reported respiratory symptom score [ Time Frame: 5 days ]Scores on an arbitrary ordinal scale of 0 to 3 (0= no symptoms, 1= a bit (mild), 2= quite bad (moderate), 3= very bad (severe)) are recorded by parents for wheeze, cough and difficulty in breathing for both day and night, giving a maximum possible symptom score of 18 for each day.
- Time to recovery [ Time Frame: 28 days ]Recovery defined as a respiratory symptom score of 5 or lower indicating only trivial symptoms
- Adverse effects [ Time Frame: 7 days ]
- Health care resource use [ Time Frame: 28 days ]Primary care physician re-consultations, medication prescriptions (e.g. antibiotics), specialist consultations and hospital admissions
- Persistent wheezing on auscultation on day 5 [ Time Frame: on day 5 ]To maximise objectivity, lung sounds will be recorded (digital stethoscope) and evaluated by an expert panel at a later date
- Day of parent reported recovery [ Time Frame: 28 days ]The number of the day on which parents felt their child was recovered
- Parent satisfaction with care [ Time Frame: on day 28 ]Single direct question "How satisfied are you with the treatment with study medication on a scale from 1 to 4 (very satisfied, satisfied, unsatisfied, very unsatisfied)?
- Out-of-pocket expenses [ Time Frame: 14 days ]Parent reported expenses for over-the-counter medication, additional travel, parking and child care, recorded in the study diary
- Parent productivity losses [ Time Frame: 14 days ]Assessed using the iMTA Productivity Cost questionnaire (iPCQ)
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): NCT04584034
|Contact: Josi A Boeijen, MD, MSc||0031 email@example.com|
|Contact: Alma C van de Pol, MD, PhD||A.C.vandePolfirstname.lastname@example.org|
|Principal Investigator:||Roger AMJ Damoiseaux, Professor||Julius Center, UMC Utrecht|
|Principal Investigator:||Ann van den Bruel, Professor||KU Leuven|