Study Summary
This trial will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo.
Eligible Conditions
- Asthma
- Wheezing
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 72 hours after randomization
21 days after randomization
Development of Azithromycin resistant organisms
Azithromycin
Day 5
Asthma
72 hours after randomization
Length of Stay
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Treatment - Active
1 of 2
Treatment - Placebo
1 of 2
Active Control
Non-Treatment Group
1476 Total Participants · 2 Treatment Groups
Primary Treatment: Treatment - Active · Has Placebo Group · Phase 3
Treatment - Active
Drug
ActiveComparator Group · 1 Intervention: Azithromycin · Intervention Types: DrugTreatment - Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours after randomization
Who is running the clinical trial?
University of ArizonaLead Sponsor
468 Previous Clinical Trials
151,735 Total Patients Enrolled
8 Trials studying Asthma
1,986 Patients Enrolled for Asthma
University of UtahOTHER
1,008 Previous Clinical Trials
1,785,906 Total Patients Enrolled
5 Trials studying Asthma
175,069 Patients Enrolled for Asthma
Emory UniversityOTHER
1,523 Previous Clinical Trials
2,712,043 Total Patients Enrolled
11 Trials studying Asthma
1,639 Patients Enrolled for Asthma
Morgan Stanley Children's HospitalOTHER
4 Previous Clinical Trials
9,840 Total Patients Enrolled
University of PittsburghOTHER
1,634 Previous Clinical Trials
16,306,389 Total Patients Enrolled
14 Trials studying Asthma
3,582 Patients Enrolled for Asthma
Children's Hospital and Health System Foundation, WisconsinOTHER
53 Previous Clinical Trials
94,673 Total Patients Enrolled
2 Trials studying Asthma
136 Patients Enrolled for Asthma
Children's Hospital Medical Center, CincinnatiOTHER
763 Previous Clinical Trials
5,420,363 Total Patients Enrolled
15 Trials studying Asthma
1,385 Patients Enrolled for Asthma
Children's Hospital of PhiladelphiaOTHER
661 Previous Clinical Trials
7,853,120 Total Patients Enrolled
13 Trials studying Asthma
3,303 Patients Enrolled for Asthma
Boston Children's HospitalOTHER
718 Previous Clinical Trials
5,322,954 Total Patients Enrolled
17 Trials studying Asthma
6,305 Patients Enrolled for Asthma
Fernando D Martinez, MDPrincipal InvestigatorUniversity of Arizona
2 Previous Clinical Trials
1,429 Total Patients Enrolled
2 Trials studying Asthma
1,429 Patients Enrolled for Asthma
Kurt Denninghoff, MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
32 Total Patients Enrolled
Charlie Casper, PhDPrincipal InvestigatorUniversity of Utah
Eligibility Criteria
Age 18 - 60 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a breathing difficulty score (PRAM) of 4 or more during your emergency room visit.
You are experiencing wheezing when you exhale, which was confirmed by a doctor or nurse when you arrived at the emergency room.
References
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- Castro-Rodriguez JA, J Rodrigo G, E Rodriguez-Martinez C. Principal findings of systematic reviews of acute asthma treatment in childhood. J Asthma. 2015;52(10):1038-45. doi: 10.3109/02770903.2015.1033725. Epub 2015 Aug 24. Erratum In: J Asthma. 2016;53(3):339.
- Demenais F, Margaritte-Jeannin P, Barnes KC, Cookson WOC, Altmuller J, Ang W, Barr RG, Beaty TH, Becker AB, Beilby J, Bisgaard H, Bjornsdottir US, Bleecker E, Bonnelykke K, Boomsma DI, Bouzigon E, Brightling CE, Brossard M, Brusselle GG, Burchard E, Burkart KM, Bush A, Chan-Yeung M, Chung KF, Couto Alves A, Curtin JA, Custovic A, Daley D, de Jongste JC, Del-Rio-Navarro BE, Donohue KM, Duijts L, Eng C, Eriksson JG, Farrall M, Fedorova Y, Feenstra B, Ferreira MA; Australian Asthma Genetics Consortium (AAGC) collaborators, Freidin MB, Gajdos Z, Gauderman J, Gehring U, Geller F, Genuneit J, Gharib SA, Gilliland F, Granell R, Graves PE, Gudbjartsson DF, Haahtela T, Heckbert SR, Heederik D, Heinrich J, Heliovaara M, Henderson J, Himes BE, Hirose H, Hirschhorn JN, Hofman A, Holt P, Hottenga J, Hudson TJ, Hui J, Imboden M, Ivanov V, Jaddoe VWV, James A, Janson C, Jarvelin MR, Jarvis D, Jones G, Jonsdottir I, Jousilahti P, Kabesch M, Kahonen M, Kantor DB, Karunas AS, Khusnutdinova E, Koppelman GH, Kozyrskyj AL, Kreiner E, Kubo M, Kumar R, Kumar A, Kuokkanen M, Lahousse L, Laitinen T, Laprise C, Lathrop M, Lau S, Lee YA, Lehtimaki T, Letort S, Levin AM, Li G, Liang L, Loehr LR, London SJ, Loth DW, Manichaikul A, Marenholz I, Martinez FJ, Matheson MC, Mathias RA, Matsumoto K, Mbarek H, McArdle WL, Melbye M, Melen E, Meyers D, Michel S, Mohamdi H, Musk AW, Myers RA, Nieuwenhuis MAE, Noguchi E, O'Connor GT, Ogorodova LM, Palmer CD, Palotie A, Park JE, Pennell CE, Pershagen G, Polonikov A, Postma DS, Probst-Hensch N, Puzyrev VP, Raby BA, Raitakari OT, Ramasamy A, Rich SS, Robertson CF, Romieu I, Salam MT, Salomaa V, Schlunssen V, Scott R, Selivanova PA, Sigsgaard T, Simpson A, Siroux V, Smith LJ, Solodilova M, Standl M, Stefansson K, Strachan DP, Stricker BH, Takahashi A, Thompson PJ, Thorleifsson G, Thorsteinsdottir U, Tiesler CMT, Torgerson DG, Tsunoda T, Uitterlinden AG, van der Valk RJP, Vaysse A, Vedantam S, von Berg A, von Mutius E, Vonk JM, Waage J, Wareham NJ, Weiss ST, White WB, Wickman M, Widen E, Willemsen G, Williams LK, Wouters IM, Yang JJ, Zhao JH, Moffatt MF, Ober C, Nicolae DL. Multiancestry association study identifies new asthma risk loci that colocalize with immune-cell enhancer marks. Nat Genet. 2018 Jan;50(1):42-53. doi: 10.1038/s41588-017-0014-7. Epub 2017 Dec 22.
- Demenais F, Margaritte-Jeannin P, Barnes KC, Cookson WOC, Altmuller J, Ang W, Barr RG, Beaty TH, Becker AB, Beilby J, Bisgaard H, Bjornsdottir US, Bleecker E, Bonnelykke K, Boomsma DI, Bouzigon E, Brightling CE, Brossard M, Brusselle GG, Burchard E, Burkart KM, Bush A, Chan-Yeung M, Chung KF, Couto Alves A, Curtin JA, Custovic A, Daley D, de Jongste JC, Del-Rio-Navarro BE, Donohue KM, Duijts L, Eng C, Eriksson JG, Farrall M, Fedorova Y, Feenstra B, Ferreira MA; Australian Asthma Genetics Consortium (AAGC) collaborators; Freidin MB, Gajdos Z, Gauderman J, Gehring U, Geller F, Genuneit J, Gharib SA, Gilliland F, Granell R, Graves PE, Gudbjartsson DF, Haahtela T, Heckbert SR, Heederik D, Heinrich J, Heliovaara M, Henderson J, Himes BE, Hirose H, Hirschhorn JN, Hofman A, Holt P, Hottenga J, Hudson TJ, Hui J, Imboden M, Ivanov V, Jaddoe VWV, James A, Janson C, Jarvelin MR, Jarvis D, Jones G, Jonsdottir I, Jousilahti P, Kabesch M, Kahonen M, Kantor DB, Karunas AS, Khusnutdinova E, Koppelman GH, Kozyrskyj AL, Kreiner E, Kubo M, Kumar R, Kumar A, Kuokkanen M, Lahousse L, Laitinen T, Laprise C, Lathrop M, Lau S, Lee YA, Lehtimaki T, Letort S, Levin AM, Li G, Liang L, Loehr LR, London SJ, Loth DW, Manichaikul A, Marenholz I, Martinez FJ, Matheson MC, Mathias RA, Matsumoto K, Mbarek H, McArdle WL, Melbye M, Melen E, Meyers D, Michel S, Mohamdi H, Musk AW, Myers RA, Nieuwenhuis MAE, Noguchi E, O'Connor GT, Ogorodova LM, Palmer CD, Palotie A, Park JE, Pennell CE, Pershagen G, Polonikov A, Postma DS, Probst-Hensch N, Puzyrev VP, Raby BA, Raitakari OT, Ramasamy A, Rich SS, Robertson CF, Romieu I, Salam MT, Salomaa V, Schlunssen V, Scott R, Selivanova PA, Sigsgaard T, Simpson A, Siroux V, Smith LJ, Solodilova M, Standl M, Stefansson K, Strachan DP, Stricker BH, Takahashi A, Thompson PJ, Thorleifsson G, Thorsteinsdottir U, Tiesler CMT, Torgerson DG, Tsunoda T, Uitterlinden AG, van der Valk RJP, Vaysse A, Vedantam S, von Berg A, von Mutius E, Vonk JM, Waage J, Wareham NJ, Weiss ST, White WB, Wickman M, Widen E, Willemsen G, Williams LK, Wouters IM, Yang JJ, Zhao JH, Moffatt MF, Ober C, Nicolae DL. Multiancestry association study identifies new asthma risk loci that colocalize with immune-cell enhancer marks. Nat Genet. 2018 Jan;50(1):42-53. doi: 10.1038/s41588-017-0014-7. Epub 2017 Dec 22.
- Fernando Martinez 2021. "AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04669288.
Frequently Asked Questions
What is the cap for participators in this clinical trial?
"Correct. The information hosted on clinicaltrials.gov verifies that this medicinal experiment, which was first posted on September 22nd 2021, is still actively recruiting participants across 6 sites for a total of 1476 patients." - Anonymous Online Contributor
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Does Treatment - Active meet the regulatory standards set forth by the FDA?
"The team at Power rated the safety of Treatment - Active as a 3 due to prior clinical evidence supporting efficacy, in addition to multiple rounds of data demonstrating its safety." - Anonymous Online Contributor
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Does the protocol for this experiment require participants to be over 25 years of age?
"For this clinical study, only patients falling within the 18-month to 5 year age range are eligible. 186 trials target children younger than 18 months while 392 studies focus on seniors above 65 years of age." - Anonymous Online Contributor
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Is there a possibility for me to participate in this experiment?
"This medical study is seeking 1476 toddlers and children with asthma. The patient's age must be between 18 months old to 5 years of age, they need to have exhibited expiratory wheezing during their emergency department visit, and a Pediatric Respiratory Assessment Measurement score higher than or equal to 4 at any time during the ED stay." - Anonymous Online Contributor
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Are there any vacancies left in this trial for participants?
"Data hosted on clinicaltrials.gov verify that this medical trial is actively looking for participants, having been originally published on September 22nd 2021 and updated most recently on November 30th 2022." - Anonymous Online Contributor
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How many medical centers are currently hosting this clinical trial?
"Patients are being admitted to the Children's Hospital of New York Medical Center in Manhattan, Cincinnati Children's Hospital Medical Centre, and Boston Children's Hospital. Additionally, 6 more medical centres will be incorporated into this trial." - Anonymous Online Contributor
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Has Treatment - Active been evaluated in any prior investigations?
"Presently, there are 55 active clinical trials investigating Treatment - Active. Of which 18 of these inquiries have advanced to Phase 3 testing. Though most studies are held in Albuquerque, New Mexico, altogether 694 sites accommodate this treatment's research." - Anonymous Online Contributor
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What medical conditions have been demonstrated to respond positively to Treatment - Active?
"Administration of Treatment - Active is a typical remedy for genital ulcer disease (GUD). Moreover, it can help treat chlamydia in adults and cervicitis." - Anonymous Online Contributor
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