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NCT05111262

Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers

Active, enrolled Phase 1, PHASE2 Last updated 17 September 2025
What this trial tests

Phase 1, PHASE2 trial testing Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA in Asthma in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
16 December 2021
Primary endpoint
30 September 2025
30 November 2025

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment60
Start date16 December 2021
Primary completion30 September 2025
Estimated completion30 November 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 12 to 75, any sex, with Asthma or Nonadherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial.
    Krings JG, Wojcik KM, Chen V, Sekhar TC, et al · · 2022 · cited 4× · PMID 36471430 · DOI 10.1186/s13063-022-06916-3
  2. Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized-controlled trial
    Krings J, Wojcik KM, Chen V, Sekhar TC, et al · · 2022 · DOI 10.21203/rs.3.rs-1746526/v1

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05111262.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing