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Corticosteroid

PT010 Inhaler for Severe Asthma (LOGOS Trial)

Phase 3
Recruiting
Led By Robert Wise, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

LOGOS Trial Summary

This trial is testing an inhaler to see if it can help people with severe asthma who aren't responding to other treatments.

Who is the study for?
Adults and adolescents aged 12 to 80 with severe asthma not well-controlled by standard treatments. Must have been diagnosed with asthma for at least a year, regularly using certain inhaled medications, and meet specific lung function criteria. Excludes current smokers or those who quit recently, people on certain other asthma or immunosuppressive drugs, recent users of oral steroids, and individuals with serious allergies to trial medication components.Check my eligibility
What is being tested?
The study is testing the effectiveness of a new inhaler containing budesonide/glycopyrronium/formoterol (BGF) compared to existing therapies for severe asthma. Participants will use one of four different dose combinations of BGF or similar medications over a variable period to see if it better controls their symptoms.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with inhaled corticosteroids and bronchodilators such as throat irritation, hoarseness, coughing, headaches, increased risk of infections like pneumonia or thrush (a fungal infection in the mouth), tremors and heart palpitations.

LOGOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable daily asthma medication regimen for at least 4 weeks.
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My lung function improved by at least 12% and 200 mL after taking albuterol.
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I am aged 12-17 and have shown a health improvement of 12% before or during the study visits.
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I have been diagnosed with asthma for over a year.
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I have been hospitalized for asthma in the last 2 months.

LOGOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 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
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Rate of severe asthma exacerbations
Secondary outcome measures
Change from baseline in morning pre-dose trough FEV1 at Week 24
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
+8 more

LOGOS Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μgExperimental Treatment1 Intervention
BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Group II: BGF MDI 320/14.4/9.6 μgExperimental Treatment1 Intervention
BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Group III: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μgActive Control1 Intervention
BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)
Group IV: Symbicort®Active Control1 Intervention
Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGF MDI 320/14.4/9.6 μg
2015
Completed Phase 3
~11120

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,285 Previous Clinical Trials
288,617,809 Total Patients Enrolled
332 Trials studying Asthma
640,739 Patients Enrolled for Asthma
Robert Wise, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
5,470 Total Patients Enrolled
3 Trials studying Asthma
381 Patients Enrolled for Asthma

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04609904 — Phase 3
Asthma Research Study Groups: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg, Symbicort®
Asthma Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT04609904 — Phase 3
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609904 — Phase 3
Asthma Patient Testimony for trial: Trial Name: NCT04609904 — Phase 3

Frequently Asked Questions

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

How many individuals are associated with this clinical trial?

"Yes. The clinicaltrials.gov website has the most recent information on this trial, which is still recruiting participants. This study was originally posted on March 1st, 2021 and was last edited on October 5th, 2022. There are 83 locations where this study is taking place and 2200 participants total."

Answered by AI

If I qualify, can I take part in this research?

"Eligibility criteria for this clinical trial include being 12-80 years old and having a diagnosis of asthma. Currently, the study is looking to enroll 2200 individuals."

Answered by AI

What other medical experiments have there been with BGF MDI 320/28.8/9.6 μg?

"In 2007, the Arthur F Gelb Medical Corporation began studying BGF MDI. 541 trials have completed since then and currently, 47 more are ongoing with many of them based in Houston, Texas."

Answered by AI

What is BGF MDI 320/28.8/9.6 μg typically given to patients for?

"BGF MDI 320/28.8/9.6 μg is a medication that has been used to treat reflex, trigeminocardiac and various other conditions like bodily secretions, rapid anticholinergic effect desired, vasomotor rhinitis."

Answered by AI

Are the requirements for participants in this research project limited to those under 30 years of age?

"The age requirements to enroll in this trial are between 12 and 80 years old."

Answered by AI

Is this a global clinical trial or are the patients all in one country?

"If you are interested in participating in this study, please note that there are 83 recruitment sites. These locations include major cities such as Houston and Newark, but also smaller towns like Lewisville. To reduce the amount of travel required, patients are encouraged to choose a location near them."

Answered by AI

Are there any dangers associated with BGF MDI 320/28.8/9.6 μg inhalation?

"BGF MDI 320/28.8/9.6 μg safety is estimated to be a 3. This is due to the fact that it is a Phase 3 trial, meaning efficacy has been supported by some data with multiple rounds of safety data also collected."

Answered by AI

Are patients currently being accepted into this drug trial?

"That is correct, the online information from clinicaltrials.gov affirms that this study is still looking for patients to participate. The trial was first posted on March 1st 2021 and has been updated as recently as October 5th of this year. They are seeking 2200 individuals at 83 different hospitals or research facilities."

Answered by AI

What are the researchers seeking to discover through this clinical trial?

"The primary outcome of this study, which will be monitored over approximately 24 weeks, is the rate of severe asthma exacerbations. Secondary outcomes include change from baseline in morning pre-dose trough FEV1 at Week 24 and percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Additional analyses will be conducted using pooled data from studies D5982C00007 and D5982C00008, including the percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at"

Answered by AI

Who else is applying?

What state do they live in?
California
New York
Texas
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have asthma and shortess of breath. My shortness of breath does not seem to be helped by medications.
PatientReceived 2+ prior treatments
~412 spots leftby Mar 2025