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PT010 Inhaler for Asthma (KALOS Trial)
KALOS Trial Summary
This trial will study how well a new inhaler works in people with severe asthma who are not well controlled with current treatments.
KALOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKALOS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KALOS Trial Design
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Who is running the clinical trial?
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- 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.I have not taken any corticosteroids in the last 4 weeks.I have had severe asthma attacks that required breathing support.I have untreated narrow angle glaucoma or vision changes in the last 3 months.You are allergic to certain medications used to treat breathing problems.I have been on a stable daily asthma medication regimen for at least 4 weeks.My lung function test after using albuterol shows my FEV1 level.Your ACQ-7 total score is 1.5 or higher at certain visits before randomization.I am a current smoker or quit smoking less than 6 months ago.I have been diagnosed with asthma for at least a year.I am between 12 and 17 years old.I was hospitalized for asthma within the last 2 months.I have been diagnosed with asthma for at least a year.I can correctly use an inhaler.Your lung function after using albuterol needs to be at a certain level.I am 18 years or older.I am between 12 and 17 years old.I have been diagnosed with COPD.I have used an oral beta2-agonist in the last 3 months.I have used a LAMA inhaler or combination therapy in the last 12 weeks.You use a nebulizer at home to take asthma medication regularly.The doctor believes that you should be treated with biological therapy for asthma.
- Group 1: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
- Group 2: Symbicort®
- Group 3: BGF MDI 320/14.4/9.6 μg
- Group 4: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
- 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
Will this research be testing the effects on patients that are over 35 years old?
"In order to be included in this clinical trial, patients must be aged 12-80. There are many other options available for younger or older patients, with 130 trials and 239 trials respectively."
How can I sign up for this testing program?
"This trial is looking for 2200 patients that suffer from asthma and meet the following additional requirements: Being between 12-80 years old, of any gender, with a BMI below 40 kg/m2. If female, they must be unable to bear children or using birth control. For participants aged 12-18, their post-albuterol FEV1 at V2 or V3 (if needed) must be under 90%. There needs to be a documented history of physician diagnosed asthma from 1 year prior to study start date. All participants much have been regularly taking ICS/LABA medication with stable doses for 4 weeks before"
How many participants are being admitted into the research project?
"That is correct. The trial, which was initially posted on December 15th 2020 and last updated September 15th 2022, is still recruiting patients according to information available on clinicaltrials.gov. There are 97 different medical centres looking for a total of 2200 individuals to participate in the study."
What ailment does BGF MDI 320/14.4/9.6 μg help patients recover from?
"BGF MDI 320/14.4/9.6 μg can be used to effectively treat patients that experience reflex, trigeminocardiac, bodily secretions, and rapid anticholinergic effect side-effects."
In how many different medical clinics is this study being run today?
"At the moment, this clinical trial is being conducted at 97 sites. Some of these locations are in Toms River, Burlington and Boerne. There are also 97 other locations. If you want to participate in this trial, it would be ideal to select a site nearest to your location to reduce travel time commitment."
Are there other examples in which BGF MDI 320/14.4/9.6 μg has been used as a medication?
"First researched in 2007 at Arthur F. Gelb Medical Corporation, BGF MDI 320/14.4/9.6 μg has completed 541 clinical trials as of now. Currently, 47 studies are ongoing with a large number of them taking place in Toms River, New jersey."
What are the primary goals of this research project?
"The primary outcome of this over a 24-week period is the rate of severe asthma exacerbations. Additionally, the study will measure the percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24, time to first moderate/severe asthma exacerbation, and the percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24."
Are we still able to enroll new participants in this research?
"Yes, you are correct. The clinicaltrials.gov website has information indicating that this study is looking for participants. The trial was first posted on December 15th 2020 and was last updated September 15th 2022. They are recruiting 2200 individuals from 97 different sites."
Are there any known dangers to BGF MDI 320/14.4/9.6 μg?
"BGF MDI 320/14.4/9.6 μg's safety is estimated to be a 3. This estimate comes from the fact that this is a Phase 3 trial, meaning there is evidence of efficacy as well as multiple rounds of data supporting safety."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Medicus Alliance Clinical Research: < 24 hours
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