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Corticosteroid
Budesonide + Formoterol Inhaler for Asthma (VATHOS Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3
Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights
VATHOS Trial Summary
This trial will study whether an inhaler containing budesonide and formoterol fumarate is effective and safe in treating asthma in adults and adolescents.
Who is the study for?
Adults and adolescents aged 12-80 with poorly controlled asthma, stable on inhaled corticosteroids or combination therapy for at least 8 weeks. Must have a history of asthma for over 6 months, non-smokers or those who quit smoking more than 6 months ago, not pregnant or breastfeeding, without life-threatening asthma events or recent hospitalizations.Check my eligibility
What is being tested?
The trial is testing different doses of Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) against an open-label Symbicort inhaler to see which is better at controlling asthma symptoms over a period of 24 weeks.See study design
What are the potential side effects?
Possible side effects include throat irritation, hoarseness, headache, rapid heartbeat, tremors, nervousness. Long-term use can sometimes lead to infections like thrush in the mouth and airways.
VATHOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function improves significantly after using albuterol.
Select...
I have been on a stable asthma medication regimen for at least 8 weeks.
VATHOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Secondary outcome measures
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 24
+3 moreSide effects data
From 2019 Phase 3 trial • 8588 Patients • NCT0246556711%
Nasopharyngitis
9%
Chronic obstructive pulmonary disease
6%
Upper respiratory tract infection
3%
Pneumonia
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
BGF MDI 320/14.4/9.6 μg
BGF MDI 160/14.4/9.6 μg
GFF MDI 14.4/9.6 μg
BFF MDI 320/9.6 μg
VATHOS Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: BFF MDI 320/9.6 μgExperimental Treatment1 Intervention
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
Group II: BFF MDI 160/9.6 μgExperimental Treatment1 Intervention
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
Group III: BD MDI 320 μgExperimental Treatment1 Intervention
Budesonide MDI (BD MDI), 320 μg
Group IV: Open-label Symbicort TBH 320/9 μgActive Control1 Intervention
Open-Label Comparator Symbicort Turbuhaler 320/9 μg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BFF MDI 320/9.6 μg
2014
Completed Phase 3
~11790
BFF MDI 160/9.6 μg
2014
Completed Phase 3
~2570
BD MDI 320 μg
2014
Completed Phase 3
~2570
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,351 Total Patients Enrolled
328 Trials studying Asthma
639,004 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 12 and 80 years old, my BMI is under 40, and if female, I am not able to have children or am using effective birth control.My cancer cannot be removed by surgery and has not been fully gone for 5 years.I have been diagnosed with asthma for at least 6 months.My lung function improves significantly after using albuterol.Your lung function test shows that your breathing capacity is lower than normal.I have been diagnosed with asthma for at least 6 months.I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.I haven't used steroids or extra inhalers for asthma or lung infections in the last 8 weeks.I do not have any major health issues that could affect my safety in the study.I have been on a stable asthma medication regimen for at least 8 weeks.I was hospitalized for asthma within the last 8 weeks.I can't stop taking certain medications that are not allowed in the study.My asthma has been stable according to my doctor's assessment.I have had severe asthma attacks that required breathing support.I will be hospitalized during the study.I currently smoke or have a history of heavy smoking.I received my COVID-19 vaccine less than a week ago.I have been on a stable asthma medication regimen for at least 8 weeks.Your lung function has not changed by 20% or more from the previous visit.My lung function improves significantly after using albuterol.Show that you can use an inhaler correctly.
Research Study Groups:
This trial has the following groups:- Group 1: BFF MDI 160/9.6 μg
- Group 2: BD MDI 320 μg
- Group 3: Open-label Symbicort TBH 320/9 μg
- Group 4: BFF MDI 320/9.6 μg
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Asthma Patient Testimony for trial: Trial Name: NCT05202262 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me how many hospitals have been selected for this experiment?
"At the moment, the trial is being conducted at 46 different facilities; these locations include Moncton, Toronto, and Columbia. If you wish to participate in the study, it would be best to select a location nearest you to reduce travel time."
Answered by AI
What harmful effects does BFF MDI 320/9.6 μg typically have on patients?
"BFF MDI 320/9.6 μg is classified as a safe medication because it is a Phase 3 trial drug. This means that there is already some data supporting its efficacy, and that there have been multiple rounds of data supporting its safety."
Answered by AI
How can I become a tester for this new medication?
"This study is looking for 630 people with asthma aged 12 and 80. Most importantly, patients are required to meet the following criteria: Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants., Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for"
Answered by AI
Are we still able to include new patients in this trial?
"The most recent information available on clinicaltrials.gov suggests that this clinical trial is still looking for participants. The trial was originally posted on 27 October 2010 and last updated on 4 November 2022."
Answered by AI
Are people who are not yet 80 years old allowed to participate in this research?
"This trial's inclusion criteria allow for patients that are aged 12-80 to participate."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Arizona
Other
California
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
2
Why did patients apply to this trial?
Need asthma treatments ta\\\. Hope Trail will improve my asthma. I am currently on symbicort but still need to use Albuterol occasionally.
PatientReceived 1 prior treatment
As I've gotten older, my Asthma has gotten worse and the existing medications don't seem to work well for me.
PatientReceived 2+ prior treatments
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