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PT010 Inhaler for Severe Asthma (LOGOS Trial)
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.
LOGOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLOGOS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LOGOS Trial Design
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Who is running the clinical trial?
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- I am aged 12-17 and have shown a health improvement of 12% before or during the study visits.Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1.I have not used any biologic treatments like omalizumab in the last 3 months.I am allergic to certain asthma or COPD medications.I've been hospitalized for severe asthma needing a breathing tube.I have used an oral beta2-agonist in the last 3 months.I have not used immunosuppressive drugs in the last 3 months.My lung function improved by at least 12% and 200 mL after taking albuterol.I am between 12 and 80 years old, with a BMI under 40. If female, I cannot have children or am using effective birth control.I have been diagnosed with asthma for over a year.I have been hospitalized for asthma in the last 2 months.My cancer is inoperable and has not been in complete remission for 5 years.I have been on a stable asthma medication like Advair or Symbicort for over 4 weeks.I have used a long-acting muscarinic antagonist in the last 12 weeks.I use a nebulizer for asthma regularly, but haven't used it for an acute attack in the last 4 weeks.I haven't taken corticosteroids for asthma or respiratory infections in the last 4 weeks.I have used steroids like Prednisone in the last 4 weeks.I have not used a depot corticosteroid in the last year.I currently smoke, or I used to smoke a lot, or I quit smoking less than 6 months ago.I have been diagnosed with asthma for at least a year.I am 18 years old or older.I have been on a stable daily asthma medication regimen for at least 4 weeks.I am between 12 and 17 years old.
- Group 1: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
- Group 2: BGF MDI 320/14.4/9.6 μg
- Group 3: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
- Group 4: Symbicort®
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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"
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