Bronchiolitis ObliteransPhase 4NCT05299567
Efficacy and Safety of Azithromycin in Patients With Bronchiolitis Obliterans
A Phase 4 study testing Azithromycin in people with Bronchiolitis Obliterans, run by Claudio Castanos.
Trial summary
Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2010to 21 Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with diagnosis of Bronchiolitis obliternas
- older than 5 years
- Ability to perform pulmonary function test
Who cannot join
- Not being able to perform lung function study adequately
- Other causes of chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis, primary or secondary immune deficiency)
- Previous history of portal hypertension, liver cirrhosis, splenomegaly or chang in normal values of laboratory at the start of the study.
- History of hypersensitivity to macrolides
About this study
Official title: Double-blind Placebo Trial to Determine the Efficacy and Safety of Treatment With Azithromycin for 6 Months in Patients With Post-infectious Bronchiolitis Obliterans
Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled.
Read the detailed description
Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI) with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea, tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest, persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation, atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on pulmonary function test.
Patients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to randomization to active drug or placebo. Pulmonary function and number of exacerbations were evaluated. Spirometry and plethysmography were performed at baseline and at 6 months. Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw). Patients had been clinically stable over the previous three weeks.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- Azithromycin
- Keywords
- bronchiolitis obliterans, Azithromycin
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called placebo
Placebo with the same color and size than azithromycin tree days a wek for 6 months
| Study group | Role | What they receive |
|---|---|---|
| azitrhomycin | Active comparator | Group1 Azitrhomycin 250 or 500 mg in capsuls tree days a week for 6 months if the patiens are less or more than 40 kg respectively Exposure Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Group 2 placebo Not exposure Placebo in capsuls tree days a week for 6 months Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation
- FEV1 in percentages
- Pulmonary exacerbation in numbers
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 posted29 Mar 2022
- Study start24 Aug 2010
- Primary completion21 Jul 2011
- Study completion21 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, double-blind, randomized study
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudio Castanos
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Claudio Castanos, Hospital JP Garrahan
- Investigators
- Claudio m Castaños, MD, Principal investigator, Hospital de Pediatria "juan P. Garrahan"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299567
- Sponsor's protocol ID
- 250463
- Status last verified
- Jan 2022
- First submitted
- 18 May 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo Trial to Determine the Efficacy and Safety of Treatment With Azithromycin for 6 Months in Patients With Post-infectious Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT05299567
- Acronym / sponsor ID
- 250463
- Conditions
- Bronchiolitis Obliterans
- Keywords
- bronchiolitis obliterans, Azithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Claudio CastanosOther government
- Study start
- 24 Aug 2010
- Primary completion
- 21 Jul 2011 (actual)
- Study completion
- 21 Jul 2011 (actual)
- First posted
- 29 Mar 2022 (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.
Placebo-controlled, double-blind, randomized study. Post-infectious bronchiolitis obliterans (PIBO) patients aged 5 years and older of both sexes were enrolled.
Detailed description
Bronchiolitis obliterans (BO) was defined as the presence of signs and symptoms of chronic obstructive lung disease: A) previously documented acute lower respiratory infection (ALRI) with persistence of airway obstruction and respiratory signs and symptoms, such as: dyspnea, tachypnea, retractions, persistent cough, increased antero-posterior diameter of the chest, persistent wheezing, crackles, exercise intolerance; B) findings such as: hyperinflation, atelectasis, and mosaic oligohemia on CT scan; and C) persistent obstructive pattern on pulmonary function test.
Patients were randomly assigned by pharmacy staff in blocks of 4 to receive either capsules of azithromycin 250 mg (Group 1) or placebo (Group 2) 3 days a week for 6 months. Patients whose weight was less than 40 kg received 250 mg 3 days a week (Monday, Wednesday, and Friday) and those weighing more than 40 kg received 500 mg in the same scheme, according to randomization to active drug or placebo. Pulmonary function and number of exacerbations were evaluated. Spirometry and plethysmography were performed at baseline and at 6 months. Variables analyzed were Forced vital capacity (FVC),Flow expiratory volume at the first second (FEV1), Total lung capacity (TLC),Residual volumen(RV),especific conductance (sGaw). Patients had been clinically stable over the previous three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled, double-blind, randomized study
| Arm | Type | Receives |
|---|---|---|
| azitrhomycin | Active comparator | Drug: AzithromycinGroup1 Azitrhomycin 250 or 500 mg in capsuls tree days a week for 6 months if the patiens are less or more than 40 kg respectively Exposure |
| Placebo | Placebo comparator | Drug: AzithromycinGroup 2 placebo Not exposure Placebo in capsuls tree days a week for 6 months |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of Bronchiolitis obliternas
- older than 5 years
- Ability to perform pulmonary function test
Key exclusion criteria (4 listed)
- Not being able to perform lung function study adequately
- Other causes of chronic lung disease (bronchopulmonary dysplasia, cystic fibrosis, primary or secondary immune deficiency)
- Previous history of portal hypertension, liver cirrhosis, splenomegaly or chang in normal values of laboratory at the start of the study.
- History of hypersensitivity to macrolides
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 |
|---|---|---|
| AzithromycinAlso: placeboPlacebo with the same color and size than azithromycin tree days a wek for 6 months | Drug | Placebo, azitrhomycin |
Primary outcome
Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation
Time frame: 6 months
1. FEV1 in percentages 2. Pulmonary exacerbation in numbers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Claudio m Castaños, MD principal investigator
Hospital de Pediatria "juan P. Garrahan"
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Bronchiolitis Obliterans, run by Claudio Castanos.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentages change in Forced Expiratory Volume in 1 second (FEV1) Number of Pulmonary exacerbation (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 29 Mar 2022.