AsthmaPhase 4NCT02003911
Azithromycin for Children Hospitalized With Asthma
A Phase 4 study testing Azithromycin in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-12 years of age
- Admission diagnosis of asthma at the Children's Hospital at Montefiore
- History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)
Who cannot join
- Concurrent bacterial infection requiring antibiotics
- Antibiotics received within previous 2 weeks
- Contraindication to azithromycin (including allergy to macrolides)
- Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis) or home oxygen requirement
- Immunodeficiency (primary or acquired)
- Chronic systemic steroid use
Show all 13Show fewer
- Invasive or non-invasive mechanical ventilation required acutely as result of current asthma admission
- Significant cardiac co-morbidity (including hemodynamically significant cardiac disease or arrhythmia)
- Liver disease (hepatitis)
- Pregnancy
- Seizure disorder, currently on anti-epileptic medication)
- Receiving albuterol every 4 hours (q4h) at the time of enrollment
- Previous enrollment in study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial of Azithromycin in Children Hospitalized With Acute Asthma Exacerbations
Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.
Read the detailed description
Asthma is a chronic lung condition that accounts for over 130,000 pediatric hospitalizations nationally at a cost of almost 1.4 billion dollars. Atypical pathogens have been implicated both in initiating asthma and triggering acute asthma exacerbations. Azithromycin, a macrolide antibiotic, is known to have antibacterial activity against atypical pathogens and gram positive bacteria. More recently, macrolides have been increasingly used and effective against gram negative bacteria and inflammation in the lungs of patients with chronic respiratory illnesses. This effect may be secondary to the immunomodulatory effects macrolides possess, in addition to their anti-bacterial effects. In long-term therapy with macrolides, patients with asthma have shown improved bronchiolar hyperreactivity, spirometry, symptoms, and quality of life. However, studies of short-term treatment in the acute setting and in children are limited. Some practitioners use azithromycin in the treatment of acute asthma, despite limited data.
The investigators propose a double-blind, randomized, placebo-controlled trial of azithromycin in children aged 4-12 years with persistent asthma hospitalized with acute asthma exacerbations. Children will be enrolled within 12 hours of admission and will be randomized to receive three days of either azithromycin or placebo suspension (10mg/kg/dose, max of 500mg). The primary outcome measure will be length of stay (LOS). Secondary outcome measures will include: days of school/work missed, readmission rates, return to medical care rates, recurrence of symptoms, and steroid courses. In the future, patients may also be approached to enroll in the "Mechanism Subset Study" a separate pilot and feasibility study which will require two blood samples and two nasal aspirate samples and will test for atypical pathogens, interleukin-8 levels, and neutrophil/eosinophil counts. The average length of stay for patients in this age range with asthma in 2011 at our institution was 3.0 days. The investigators will enroll to achieve a power of 80%, with an alpha of 0.05, which will require 107 patients in each group to detect a 16 hour (0.67 day) difference in the primary outcome, LOS. This study hypothesizes that azithromycin treatment in children hospitalized with acute asthma will decrease LOS.
- Conditions
- Asthma
- Being tested
- Azithromycin, Placebo
- Keywords
- Asthma, Acute asthma exacerbation, Pediatric, Azithromycin, Macrolide, Length of Stay, Hospital Medicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Azithromycin suspension (200mg/5mL)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin suspension | Experimental | Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days Receives: Drug: Azithromycin |
| Placebo suspension | Placebo comparator | Same volume as active drug
Once daily for 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Hospital length of stay
Measured: Admission time to discharge time (average LOS is 3 days)
Secondary outcomes (7)
Readmission Rate
Number of hospital readmissions for asthma at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
School Missed
Days of school missed by patient at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
Work Missed
Days of work missed by parent/guardian at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
Emergency Room Visits
Number of emergency room visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
Physician Office Visits
Number of physician office visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
Recurrence of Asthma Symptoms
Number of recurrences of asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Measured: One month after discharge
Steroid Courses
Number of courses of oral steroids since discharge at telephone follow-up phone call 1-month after discharge
Measured: One month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsey C Douglas, MD, Principal investigator, Montefiore Medical CenterKatherine O'Connor, MD, Study director, Montefiore Medical CenterDiana S. Lee, MD, Study director, Montefiore Medical CenterAlyssa H Silver, MD, Study director, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003911
- Sponsor's protocol ID
- 12-05-187
- Status last verified
- Aug 2020
- First submitted
- 21 Nov 2013
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Trial of Azithromycin in Children Hospitalized With Acute Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT02003911
- Acronym / sponsor ID
- 12-05-187
- Conditions
- Asthma
- Keywords
- Asthma, Acute asthma exacerbation, Pediatric, Azithromycin, Macrolide, Length of Stay, Hospital Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a chronic lung condition in children, and often requires hospitalization for acute exacerbations. Azithromycin has been used successfully in other chronic lung diseases, including cystic fibrosis. Despite limited clinical evidence, some pediatricians use azithromycin in children hospitalized with asthma, citing either treatment of atypical pathogens or its proposed anti-inflammatory properties. This study proposes a clinical trial to determine if azithromycin will shorten length of stay in children hospitalized with acute asthma exacerbations.
Detailed description
Asthma is a chronic lung condition that accounts for over 130,000 pediatric hospitalizations nationally at a cost of almost 1.4 billion dollars. Atypical pathogens have been implicated both in initiating asthma and triggering acute asthma exacerbations. Azithromycin, a macrolide antibiotic, is known to have antibacterial activity against atypical pathogens and gram positive bacteria. More recently, macrolides have been increasingly used and effective against gram negative bacteria and inflammation in the lungs of patients with chronic respiratory illnesses. This effect may be secondary to the immunomodulatory effects macrolides possess, in addition to their anti-bacterial effects. In long-term therapy with macrolides, patients with asthma have shown improved bronchiolar hyperreactivity, spirometry, symptoms, and quality of life. However, studies of short-term treatment in the acute setting and in children are limited. Some practitioners use azithromycin in the treatment of acute asthma, despite limited data.
The investigators propose a double-blind, randomized, placebo-controlled trial of azithromycin in children aged 4-12 years with persistent asthma hospitalized with acute asthma exacerbations. Children will be enrolled within 12 hours of admission and will be randomized to receive three days of either azithromycin or placebo suspension (10mg/kg/dose, max of 500mg). The primary outcome measure will be length of stay (LOS). Secondary outcome measures will include: days of school/work missed, readmission rates, return to medical care rates, recurrence of symptoms, and steroid courses. In the future, patients may also be approached to enroll in the "Mechanism Subset Study" a separate pilot and feasibility study which will require two blood samples and two nasal aspirate samples and will test for atypical pathogens, interleukin-8 levels, and neutrophil/eosinophil counts. The average length of stay for patients in this age range with asthma in 2011 at our institution was 3.0 days. The investigators will enroll to achieve a power of 80%, with an alpha of 0.05, which will require 107 patients in each group to detect a 16 hour (0.67 day) difference in the primary outcome, LOS. This study hypothesizes that azithromycin treatment in children hospitalized with acute asthma will decrease LOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin suspension | Experimental | Drug: AzithromycinAzithromycin suspension at 10mg/kg/dose (max 500mg) Once daily for 3 days |
| Placebo suspension | Placebo comparator | Drug: PlaceboSame volume as active drug Once daily for 3 days |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4-12 years of age
- Admission diagnosis of asthma at the Children's Hospital at Montefiore
- History of persistent asthma (as defined by National Heart, Lung, and Blood Institute)
Key exclusion criteria (13 listed)
- Concurrent bacterial infection requiring antibiotics
- Antibiotics received within previous 2 weeks
- Contraindication to azithromycin (including allergy to macrolides)
- Chronic lung disease other than asthma (including bronchopulmonary dysplasia, cystic fibrosis, bronchiectasis) or home oxygen requirement
- Immunodeficiency (primary or acquired)
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 |
|---|---|---|
| AzithromycinAzithromycin suspension (200mg/5mL) | Drug | Azithromycin suspension |
| Placebo | Drug | Placebo suspension |
Primary outcome
Length of Stay
Time frame: Admission time to discharge time (average LOS is 3 days)
Hospital length of stay
7 secondary outcomes
Readmission Rate
Time frame: One month after discharge
School Missed
Time frame: One month after discharge
Work Missed
Time frame: One month after discharge
Emergency Room Visits
Time frame: One month after discharge
Physician Office Visits
Time frame: One month after discharge
Recurrence of Asthma Symptoms
Time frame: One month after discharge
Steroid Courses
Time frame: One month after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Asthma
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.
Lindsey C Douglas, MD principal investigator
Montefiore Medical Center
Katherine O'Connor, MD study director
Montefiore Medical Center
Diana S. Lee, MD study director
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Asthma, run by Montefiore Medical Center at 1 site in United States.
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 13 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: stopped early, as of the sponsor's last update on 13 Aug 2020. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay (time frame: Admission time to discharge time (average LOS is 3 days)). 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 13 Aug 2020.