← Back to Search

Combination Therapy

PT010 Inhaler for Asthma (KALOS Trial)

Verified Trial
Phase 3
Recruiting
Led By Andrew Menzies-Gow, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Participants ≥ 18 years of age: < 80%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

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.

Who is the study for?
This trial is for adults and adolescents aged 12-80 with severe asthma that isn't well-controlled by their current treatment. They must have a BMI under 40, not be pregnant or breastfeeding, and use effective birth control if applicable. Participants should have been on a stable dose of inhaled corticosteroids and long-acting beta agonists for at least four weeks.Check my eligibility
What is being tested?
The study tests different doses of an inhaler containing budesonide/glycopyrronium/formoterol (BFF/BGF) to see how safe and effective they are compared to standard care for severe asthma. The trial will randomly assign participants to receive one of the various dosages.See study design
What are the potential side effects?
Potential side effects may include sore throat, headache, sinusitis, upper respiratory infection, thrush in the mouth and throat (candidiasis), coughing, muscle cramps, nausea or vomiting. Some people might experience increased heart rate or changes in blood pressure.

KALOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with asthma for at least a year.
Select...
I am 18 years or older.
Select...
I am between 12 and 17 years old.
Select...
Your lung function after using albuterol needs to be at a certain level.
Select...
I can correctly use an inhaler.

KALOS 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

KALOS 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
4,265 Previous Clinical Trials
288,603,082 Total Patients Enrolled
328 Trials studying Asthma
637,434 Patients Enrolled for Asthma
Andrew Menzies-Gow, MDPrincipal InvestigatorRoyal Brompton Hospital, United Kingdom
2 Previous Clinical Trials
2,012 Total Patients Enrolled
2 Trials studying Asthma
2,012 Patients Enrolled for Asthma

Media Library

Budesonide/Glycopyrronium/Formoterol Inhaler (Combination Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04609878 — Phase 3
Asthma Research Study Groups: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg, Symbicort®, BGF MDI 320/14.4/9.6 μg, Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
Asthma Clinical Trial 2023: Budesonide/Glycopyrronium/Formoterol Inhaler Highlights & Side Effects. Trial Name: NCT04609878 — Phase 3
Budesonide/Glycopyrronium/Formoterol Inhaler (Combination Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04609878 — Phase 3
Asthma Patient Testimony for trial: Trial Name: NCT04609878 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Medicus Alliance Clinical Research
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

Seeing if something works better. Hopefully something new wood work better.
PatientReceived no prior treatments
To further medical research and find better medication for asthma issues. I have had issues with my asthma since I was a kid. It has gotten more severe over the years. I find myself making trips to the ER 5 or more times a year due to asthma flare ups. I have tried several medications to try to control it, but nothing seems to be able to get it controlled for very long. I also have a nebulizer I have to use quite often. Asthma attacks are scary and painful and I would love to find a medicine that works to reduce mine.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Medicus Alliance Clinical Research: < 24 hours
~475 spots leftby Mar 2025