NCT04584034

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

September 3, 2020

Last Update Submit

July 16, 2021

Conditions

Wheezing

Keywords

WheezeViral respiratory illnessesPre-school age childrenPrimary careGeneral practiceSalbutamolBronchodilatorsTherapeutic trial

Outcome Measures

Primary Outcomes (1)

  • Course of the parent reported respiratory symptom score

    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.

    5 days

Secondary Outcomes (8)

  • Time to recovery

    28 days

  • Adverse effects

    7 days

  • Health care resource use

    28 days

  • Persistent wheezing on auscultation on day 5

    on day 5

  • Day of parent reported recovery

    28 days

  • +3 more secondary outcomes

Study Arms (2)

Salbutamol

ACTIVE COMPARATOR

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

Drug: Salbutamol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SalbutamolDRUG

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

Also known as: Ventolin, β2-adrenoceptor agonist, Bronchodilator, Salbutamol sulfate
Salbutamol
PlaceboDRUG

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

Also known as: Mock inhaler
Placebo

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Matricardi PM, Illi S, Gruber C, Keil T, Nickel R, Wahn U, Lau S. Wheezing in childhood: incidence, longitudinal patterns and factors predicting persistence. Eur Respir J. 2008 Sep;32(3):585-92. doi: 10.1183/09031936.00066307. Epub 2008 May 14.

    PMID: 18480107BACKGROUND

  • Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.

    PMID: 7800004BACKGROUND

  • Mallol J, Garcia-Marcos L, Sole D, Brand P; EISL Study Group. International prevalence of recurrent wheezing during the first year of life: variability, treatment patterns and use of health resources. Thorax. 2010 Nov;65(11):1004-9. doi: 10.1136/thx.2009.115188. Epub 2010 Sep 20.

    PMID: 20855440BACKGROUND

  • Chavasse R, Seddon P, Bara A, McKean M. Short acting beta agonists for recurrent wheeze in children under 2 years of age. Cochrane Database Syst Rev. 2002;2002(3):CD002873. doi: 10.1002/14651858.CD002873.

    PMID: 12137663BACKGROUND

MeSH Terms

Conditions

Respiratory Sounds

Interventions

AlbuterolBronchodilator Agents

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAutonomic AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Asthmatic AgentsRespiratory System AgentsTherapeutic Uses

Study Officials

  • Roger AMJ Damoiseaux, Professor

    Julius Center, UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Ann van den Bruel, Professor

    KU Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individually randomised, placebo-controlled, multicentre, parallel group trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, department of General Practice

Study Record Dates

First Submitted

September 3, 2020

First Posted

October 12, 2020

Study Start

September 1, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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.