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New treatment option for Childhood Asthma With Acute Exacerbation
Official title Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
ClinicalTrials.gov ID: NCT05028153
What this study is testing
What is Azithromycin Oral Liquid Product?
Azithromycin Oral Liquid Product is an investigational medicine, being studied as a potential treatment for childhood asthma with acute exacerbation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 71
You may be able to join if
- Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
- The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
- The child is between 12-71 months old.
- Fluent Danish skills with parents / guardians.
You likely can't join if
- Known allergy to macrolide antibiotics.
- Known impaired liver function.
- Known renal impairment.
- Known with neurological or psychiatric diseases.
- Known with congenital or documented acquired QT interval.
- Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
See the full eligibility criteria
- Previous episode(s) with asthma-like symptoms and / medical treatment with SABA as mono-therapy or SABA in combination with ICS and possibly LTRA.
- The parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial.
- The child is between 12-71 months old.
- Fluent Danish skills with parents / guardians.
- Known allergy to macrolide antibiotics.
- Known impaired liver function.
- Known renal impairment.
- Known with neurological or psychiatric diseases.
- Known with congenital or documented acquired QT interval.
- Known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure.
- Clinical signs of pneumonia (Objective findings, including severe tachypnoea: respiratory rate (RF)\> 50 and / or Fever: temperature\> 39 °C and / or C-reactive protein (CRP)\> 50).
The study team makes the final eligibility decision.
Where it's taking place
- Gentofte Municipality, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 71 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gentofte Municipality, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.