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Trial record 1 of 1 for:    NCT04584034
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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
Sponsor:
Collaborators:
KU Leuven
Maastricht University Medical Center
Universiteit Antwerpen
Université de Liège
Information provided by (Responsible Party):
prof. dr. R.A.M.J. Damoiseaux, UMC Utrecht

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individually randomised, placebo-controlled, multicentre, parallel group trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Salbutamol
Salbutamol inhalation 4x200ug daily for 7 days, delivered using a Babyhaler
Drug: Salbutamol
Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.
Other Names:
  • Ventolin
  • β2-adrenoceptor agonist
  • Bronchodilator
  • Salbutamol sulfate

Placebo Comparator: Placebo
Placebo 4 x 2 inhalations daily for 7 days, delivered using a Babyhaler
Drug: Placebo
The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.
Other Name: Mock inhaler




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to recovery [ Time Frame: 28 days ]
    Recovery defined as a respiratory symptom score of 5 or lower indicating only trivial symptoms

  2. Adverse effects [ Time Frame: 7 days ]
  3. Health care resource use [ Time Frame: 28 days ]
    Primary care physician re-consultations, medication prescriptions (e.g. antibiotics), specialist consultations and hospital admissions

  4. 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

  5. Day of parent reported recovery [ Time Frame: 28 days ]
    The number of the day on which parents felt their child was recovered

  6. 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)?

  7. 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

  8. Parent productivity losses [ Time Frame: 14 days ]
    Assessed using the iMTA Productivity Cost questionnaire (iPCQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Josi A Boeijen, MD, MSc 0031 650177145 j.a.boeijen-3@umcutrecht.nl
Contact: Alma C van de Pol, MD, PhD A.C.vandePol-11@umcutrecht.nl

Sponsors and Collaborators
UMC Utrecht
KU Leuven
Maastricht University Medical Center
Universiteit Antwerpen
Université de Liège
Investigators
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Principal Investigator: Roger AMJ Damoiseaux, Professor Julius Center, UMC Utrecht
Principal Investigator: Ann van den Bruel, Professor KU Leuven
Publications:
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Responsible Party: prof. dr. R.A.M.J. Damoiseaux, Full Professor, department of General Practice, UMC Utrecht
ClinicalTrials.gov Identifier: NCT04584034    
Other Study ID Numbers: NL72651
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will make our data accessable for verification and future research (other researchers / spin-off projects), yet these will be shared under restrictions. Data cannot be reused without consulting the research team.
Time Frame: Data will only be accessable after publication of trial results. Data will be stored for at least 25 years.
Access Criteria: On request, after approval of principle investigator.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by prof. dr. R.A.M.J. Damoiseaux, UMC Utrecht:
Wheeze
Viral respiratory illnesses
Pre-school age children
Primary care
General practice
Salbutamol
Bronchodilators
Therapeutic trial
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action