Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT06307665
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • BDA MDI — COMBINATION_PRODUCT
    Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
  • AS MDI — COMBINATION_PRODUCT
    Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

Study Details

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Key Dates

Start date
May 20, 2024
Status verified
Jun 2026
Primary completion
Oct 13, 2027
Completion
Oct 13, 2027

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Budesonide/albuterol metered -dose inhaler (BDA MDI)
    Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
  • Active Comparator: Albuterol sulfate metered-dose inhaler (AS MDI)
    Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.

Primary Outcome Measure

Annualized rate of severe asthma exacerbations (AAER) [ Time Frame: From Randomization (Day 1) to Week 52 (EOT) ]

Central Contacts

Locations (105)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SiteGilbertArizona85234-
Research SitePhoenixArizona85016-
Research SiteLittle RockArkansas72202-
Research SiteHuntington BeachCalifornia92647-
Research SiteHuntington BeachCalifornia92648-
Research SiteLong BeachCalifornia90806-
Research SiteLong BeachCalifornia90815-
Research SiteMaderaCalifornia93636-
Research SiteMission ViejoCalifornia92691-
Research SiteMoreno ValleyCalifornia92553-
Research SiteOrangeCalifornia92868-
Research SiteRedondo BeachCalifornia90277-
Research SiteRiversideCalifornia92506-
Research SiteSan DiegoCalifornia92123-
Research SiteSan DiegoCalifornia92123-
Research SiteSan FranciscoCalifornia94143-
Research SiteWestminsterCalifornia92683-
Research SiteDenverColorado80206-
Research SiteWilmingtonDelaware19803-
Research SiteDestinFlorida32541-
Research SiteJacksonvilleFlorida32207-
Research SiteKendallFlorida33176-
Research SiteLargoFlorida33777-
Research SiteMiamiFlorida33145-
Research SitePembroke PinesFlorida33026-
Research SiteTampaFlorida33613-
Research SiteAtlantaGeorgia30329-
Research SiteColumbusGeorgia31904-
Research SiteFayettevilleGeorgia30214-
Research SiteSnellvilleGeorgia30078-
Research SiteMeridianIdaho83646-
Research SiteNormalIllinois61761-
Research SiteRiver ForestIllinois60305-
Research SiteIndianapolisIndiana46202-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40202-
Research SiteLafayetteLouisiana70508-
Research SiteNew OrleansLouisiana70121-
Research SiteEllicott CityMaryland21043-
Research SiteSilver SpringMaryland20902-
Research SiteWhite MarshMaryland21162-
Research SiteBostonMassachusetts02114-
Research SiteDetroitMichigan48201-
Research SiteMankatoMinnesota56001-
Research SiteKansas CityMissouri64108-
Research SiteKansas CityMissouri64118-
Research SiteMissoulaMontana59804-
Research SiteLincolnNebraska68510-
Research SiteLincolnNebraska68516-
Research SiteOmahaNebraska68114-
Research SiteNewarkNew Jersey07103-
Research SiteNorthfieldNew Jersey08225-
Research SiteOcean CityNew Jersey07712-
Research SiteParamusNew Jersey07652-
Research SiteAlbuquerqueNew Mexico87106-
Research SiteAlbanyNew York12208-
Research SiteCortlandNew York13045-
Research SiteHawthorneNew York10532-
Research SiteHollisNew York11423-
Research SiteNew YorkNew York10019-
Research SiteNew YorkNew York10032-
Research SiteRochesterNew York14607-
Research SiteThe BronxNew York10459-
Research SiteThe BronxNew York10461-
Research SiteVestalNew York13850-
Research SiteVestalNew York13850-
Research SiteWatertownNew York13601-
Research SiteCharlotteNorth Carolina28277-
Research SiteCincinnatiOhio45229-
Research SiteColumbusOhio43205-
Research SiteColumbusOhio43228-
Research SiteDaytonOhio45424-
Research SiteFindlayOhio45840-
Research SiteToledoOhio43617-
Research SiteOklahoma CityOklahoma73104-
Research SiteOklahoma CityOklahoma73120-
Research SiteYukonOklahoma73099-
Research SitePittsburghPennsylvania15241-
Research SiteCharlestonSouth Carolina29425-
Research SiteRock HillSouth Carolina29730-
Research SiteSioux FallsSouth Dakota57105-
Research SiteNashvilleTennessee37232-
Research SiteAustinTexas78759-
Research SiteBaytownTexas77521-
Research SiteBeaumontTexas77701-
Research SiteBeaumontTexas77702-
Research SiteBellaireTexas77401-
Research SiteCorsicanaTexas75110-
Research SiteDallasTexas75231-
Research SiteEl PasoTexas79912-
Research SiteFriscoTexas75034-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77065-
Research SiteHoustonTexas77099-
Research SiteKerrvilleTexas78028-
Research SiteMcKinneyTexas75069-
Research SiteSan AntonioTexas78215-
Research SiteSan AntonioTexas78229-
Research SiteTylerTexas75708-
Research SiteWest JordanUtah84088-
Research SiteBurlingtonVermont05405-
Research SiteBurkeVirginia22015-
Research SiteBellinghamWashington98225-
Research SiteVancouverWashington98664-

Find similar trials in Anchorage, AK

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
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