TracheomalaciaPhase 3TRALULALA-AZINCT06409299
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention
A Phase 3 study testing Azithromycin 40 MG/ML in people with Tracheomalacia and Bronchopulmonary Dysplasia (BPD), run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed. Read more about this study
- Who is it for?
- Ages 0 to 72 months
- Conditions the study is for
- Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring
- What is being tested?
- Azithromycin 40 MG/ML
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Phase 3
- 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 0 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations
- Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.
- At risk of or already documented respiratory infections requiring antibiotics.
- Age between 0-72 months at inclusion.
Who cannot join
- Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.
- Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.
- Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.
- Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.
- Neurological or psychiatric disorders
- Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.
- Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.
- Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.
About this study
Official title: Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention
Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.
The link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.
Read more
Experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.
To address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.
- Conditions
- Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring, Cystic Lung Disease, Bronchiectasis, Chronic Atelectasis
- Being tested
- Azithromycin 40 MG/ML, Placebo
- Medical subject headings
- Tracheomalacia, Bronchopulmonary Dysplasia, Vascular Ring, Cystic Disease Of Lung, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 40 MG/MLDrug
Maintenance Antibiotic treatment
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Oral Suspension 40 mg/ml | Active comparator | Not described Receives: Drug: Azithromycin 40 MG/ML |
| Placebo Oral suspension | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of exacerbations
Number of exacerbations where systemic antibiotics is needed within the study period
Measured: 6 months
Secondary outcomes (1)
Severity of exacerbations
Duration of exacerbations, hospitalizations and durations of hospitalizations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheomalaciaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study comprises a multicenter, parallel-group, double-blind, randomized placebo-controlled clinical trial (RCT) with a single intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marika Nathalie Schmidt, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409299
- Sponsor's protocol ID
- p-2024-15966
- Acronym
- TRALULALA-AZI
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention
- ClinicalTrials.gov ID
- NCT06409299
- Acronym / sponsor ID
- TRALULALA-AZI / p-2024-15966
- Conditions
- Tracheomalacia, Bronchopulmonary Dysplasia (BPD), Vascular Ring, Cystic Lung Disease, Bronchiectasis, Chronic Atelectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 May 2024 (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.
Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.
The link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.
Experts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.
To address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study comprises a multicenter, parallel-group, double-blind, randomized placebo-controlled clinical trial (RCT) with a single intervention.
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Oral Suspension 40 mg/ml | Active comparator | Drug: Azithromycin 40 MG/ML |
| Placebo Oral suspension | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 0 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations
- Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.
- At risk of or already documented respiratory infections requiring antibiotics.
- Age between 0-72 months at inclusion.
Key exclusion criteria (8 listed)
- Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.
- Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.
- Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.
- Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.
- Neurological or psychiatric disorders
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 40 MG/MLMaintenance Antibiotic treatment | Drug | Azithromycin Oral Suspension 40 mg/ml |
| PlaceboPlacebo | Other | Placebo Oral suspension |
Primary outcome
Incidence of exacerbations
Time frame: 6 months
Number of exacerbations where systemic antibiotics is needed within the study period
1 secondary outcome
Severity of exacerbations
Time frame: 6 months
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 14 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin 40 MG/ML in people with Tracheomalacia and Bronchopulmonary Dysplasia (BPD), run by Copenhagen University Hospital, Rigshospitalet.
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 8 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: opening soon, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of exacerbations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.