← Back to Search

Corticosteroid and Long-Acting Beta Agonist Combination

ICS/LABA Therapy for Asthma Non-adherence

Phase 1 & 2
Recruiting
Led By James G Krings, MD MSc
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial aims to improve adherence to maintenance inhalers in asthmatic patients, which could help reduce hospitalizations due to asthma.

Who is the study for?
This trial is for people aged 12-75 with mild or moderate persistent asthma who have been prescribed maintenance inhalers and as-needed SABA but are not using their inhalers regularly. They must own a smartphone, have missed at least two ICS refills in the past six months, and have partially controlled to moderately uncontrolled asthma.Check my eligibility
What is being tested?
The study compares adherence to budesonide/formoterol taken only when symptoms occur versus regular use of maintenance ICS plus symptom-driven SABA. It aims to address the issue of patients not sticking to daily inhaler routines by testing a new method that matches medication intake with symptom occurrence.See study design
What are the potential side effects?
Possible side effects include those commonly associated with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), such as throat irritation, hoarseness, coughing, headaches, and increased risk of infections like pneumonia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Secondary outcome measures
Adverse and serious adverse events
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Quality of Life Questionnaire (AQLQ)
+8 more

Trial Design

2Treatment groups
Active Control
Group I: As needed inhaled corticosteroid and long-acting beta-agonistActive Control1 Intervention
Symptom-driven ICS/LABA treatment strategy
Group II: Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonistActive Control1 Intervention
Continue maintenance ICS and SABA therapy

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,665 Total Patients Enrolled
16 Trials studying Asthma
2,987 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,479 Total Patients Enrolled
58 Trials studying Asthma
8,247 Patients Enrolled for Asthma
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,689 Total Patients Enrolled
5 Trials studying Asthma
361 Patients Enrolled for Asthma

Media Library

Budesonide/Formoterol (Corticosteroid and Long-Acting Beta Agonist Combination) Clinical Trial Eligibility Overview. Trial Name: NCT05111262 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what condition is As needed inhaled corticosteroid and long-acting beta-agonist most frequently recommended?

"Acute coryza can be managed by the use of As-needed inhaled corticosteroid and long-acting beta-agonist. This medication has also been proven to ameliorate nasal congestion, proteinuria, and Crohn's disease."

Answered by AI

Who meets the qualifications to participate in this experiment?

"This clinical trial is accommodating 60 individuals, aged 18 to 75 years old, with uncompliant medication for moderate or mild persistent asthma. To be eligible for the study, candidates must fulfill the following criteria: Be capable of comprehending and giving informed consent., Fall between age from eighteen to seventy-five when participating in the experiment., Have a provider diagnosed light or medium lasting bronchial asthma and has been given maintenance ICS treatment plus as needed SABA at least 6 months before enrollment., Inferior adherence to prescribed maintenance ICS therapy specified by missing at least anticipated two ICS refills during prior six months based on pharmacy records inspection"

Answered by AI

Is this research initiative recruiting geriatric individuals?

"In accordance with this trial's entry requirements, the minimal age of enrollment is 18 while no patient above 75 can take part."

Answered by AI

Is this research undertaking presently open to recruitment?

"Affirmative. Information available on clinicaltrials.gov attests to the fact that this medical trial, which was inaugurated on December 16th 2021 is actively recruiting participants for a 60 person cohort at one research site."

Answered by AI

What is the current enrollment capacity of this trial?

"Affirmative, the clinical trial is still accepting applications. Documents posted on clinicaltrials.gov indicate that this research opened for enrollment on December 16th 2021 and was last updated a day later. The investigators are looking to recruit 60 individuals from one medical centre."

Answered by AI

Have any other experiments been conducted to determine the efficacy of As needed inhaled corticosteroid and long-acting beta-agonist?

"Presently, 32 studies are being conducted for As needed inhaled corticosteroid and long-acting beta-agonist; 11 of which have reached the third phase. While most research is situated in Xi'an, Shaanxi, there are 998 sites across the world assessing this novel therapy."

Answered by AI
~18 spots leftby Apr 2025