Childhood Asthma With Acute ExacerbationPhase 2COPSACaztNCT05028153
Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms
A Phase 2 study testing Azithromycin Oral Liquid Product in people with Childhood Asthma With Acute Exacerbation, run by Copenhagen Studies on Asthma in Childhood at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Childhood Asthma With Acute Exacerbation
- What is being tested?
- Azithromycin Oral Liquid Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Nov 2022to 13 Nov 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital of Copenhagen
Gentofte Municipality, 2820
Klaus Bønnelykke, MD, PhD, +45 3867 7360, kb@copsac.com
Ulrik Ralfkiaer, MSc, PhD, +45 3867 4164, administration@dbac.dk
About this study
Official title: Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
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.
Read the detailed description
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
The study hypothesis is:
● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
- Conditions
- Childhood Asthma With Acute Exacerbation
- Being tested
- Azithromycin Oral Liquid Product, Placebo mixture
- Keywords
- Asthma, Infections, Wheeze, Antibiotics
- Medical subject headings
- Asthma, Infections, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Oral Liquid ProductDrug
10 mg/kg for 3 consecutive days
Placebo mixtureOther
Placebo mixture containing no active substance
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Active comparator | Azithromycin (10mg/kg) administered via oral suspension for 3 consecutive days Receives: Drug: Azithromycin Oral Liquid Product |
| Placebo | Placebo comparator | Placebo with no active substance administered via oral suspension for 3 consecutive days Receives: Other: Placebo mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration in days of the asthma-like episode from the start of randomization.
Number of days based on a diary.
Measured: 1-30 days
Secondary outcomes (12)
Change in symptom score.
Using a previously validated symptom scoring model based on a diary. The score range is from 0 (no symptoms) and up to 3 (depending on presence of one or more of the followings symptoms: Cough, breathlessness and wheezing).
Measured: From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.
Effect modification in relation to the child's respiratory microbiota profile.
Airway microbiota, pathogenic bacteria and vira as measured by 16S-rRNA and whole genome sequencing.
Measured: Sample time, day 1
Effect modification in relation to the child's respiratory immunological profile.
Evaluation of immune mediator profiles (cytokine and chemokine levels) in the upper airway epithelial lining fluid.
Measured: Sample time, day 1
The length of hospitalization (days)
Determined by participants medical record.
Measured: 1-30 days
Need for SABA during the asthma-like episode
Number of days based on a diary.
Measured: 1-30 days
Need for oral corticosteroids (OCS) during the asthma-like episode.
Number of days based on a diary.
Measured: 1-30 days
Stratification of the above analyzes.
On the basis of the presence or absence of bacteria/microbiota in the respiratory tract, based on outcomes 3, 4 and 5.
Measured: Sample time, day 1
Number of days away from daycare offers.
Number of days based on a diary.
Measured: 1-30 days
Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s)
The number of days home from daycare causing parent absenteeism due to illness based on this diary registration.
Measured: 1-30 days
Gut microbiome profile
Occurrence, diversity and abundance of gut microbiota using 16S rRNA sequencing and whole genome sequencing.
Measured: 1-30 days
Resistance profiles
Occurrence, diversity and abundance of antibiotic resistance genes as assessed by metagenome sequencing.
Measured: 1-30 days
Adverse Event (AE) registration
Number of events and type of event based on a diary.
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start14 Nov 2022
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Asthma With Acute ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen Studies on Asthma in Childhood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Stokholm, MD, PhD, Principal investigator, University Hospital of Copenhagen, DK-2820 Gentofte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028153
- Sponsor's protocol ID
- H-20065249
- Acronym
- COPSACazt
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2021
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762.
PubMed 35418427
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Treatment of Hospitalized Children With Asthmatic Symptoms: A Double-blinded, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05028153
- Acronym / sponsor ID
- COPSACazt / H-20065249
- Conditions
- Childhood Asthma With Acute Exacerbation
- Keywords
- Asthma, Infections, Wheeze, Antibiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Copenhagen Studies on Asthma in ChildhoodUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2032 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with SABA as monotherapy or SABA in combination with ICS and possibly LTRA. The primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. In this study, hospitalized children who provide a more diverse group than the COPSAC2010 cohort will be included. In addition, the study aims to focus on examining the individual response to treatment. The expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. The expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these.
The study hypothesis is:
● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with SABA as monotherapy, or SABA in combination with ICS and possibly LTRA, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Active comparator | Drug: Azithromycin Oral Liquid ProductAzithromycin (10mg/kg) administered via oral suspension for 3 consecutive days |
| Placebo | Placebo comparator | Other: Placebo mixturePlacebo with no active substance administered via oral suspension for 3 consecutive days |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Oral Liquid Product10 mg/kg for 3 consecutive days | Drug | Antibiotics |
| Placebo mixturePlacebo mixture containing no active substance | Other | Placebo |
Primary outcome
Duration in days of the asthma-like episode from the start of randomization.
Time frame: 1-30 days
Number of days based on a diary.
12 secondary outcomes
Change in symptom score.
Time frame: From day 1 after randomization to completion of each randomized asthmatic episode aged 1-5 years.
Effect modification in relation to the child's respiratory microbiota profile.
Time frame: Sample time, day 1
Effect modification in relation to the child's respiratory immunological profile.
Time frame: Sample time, day 1
The length of hospitalization (days)
Time frame: 1-30 days
Need for SABA during the asthma-like episode
Time frame: 1-30 days
Need for oral corticosteroids (OCS) during the asthma-like episode.
Time frame: 1-30 days
Stratification of the above analyzes.
Time frame: Sample time, day 1
Number of days away from daycare offers.
Time frame: 1-30 days
Health economic gain based on treatment costs and lost earnings. lost earnings for parent / guardian (s)
Time frame: 1-30 days
Gut microbiome profile
Time frame: 1-30 days
Resistance profiles
Time frame: 1-30 days
Adverse Event (AE) registration
Time frame: 1-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 35418427Kyvsgaard JN, Ralfkiaer U, Folsgaard N, Jensen TM, Hesselberg LM, Schoos AM, Bonnelykke K, Bisgaard H, Stokholm J, Chawes B. Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial. BMJ Open. 2022 Apr 13;12(4):e054762. doi: 10.1136/bmjopen-2021-054762.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob Stokholm, MD, PhD principal investigator
University Hospital of Copenhagen, DK-2820 Gentofte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin Oral Liquid Product in people with Childhood Asthma With Acute Exacerbation, run by Copenhagen Studies on Asthma in Childhood at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klaus Bønnelykke, MD, PhD (+4538677360, kb@copsac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration in days of the asthma-like episode from the start of randomization. (time frame: 1-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.