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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
No Placebo-Only Group
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma for at least a year.
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I am 18 years or older.
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I am between 12 and 17 years old.
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Your lung function after using albuterol needs to be at a certain level.
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I can correctly use an inhaler.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
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.
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
4,397 Previous Clinical Trials
289,119,457 Total Patients Enrolled
347 Trials studying Asthma
659,269 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
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.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.
Research Study Groups:
This trial has the following groups:- 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
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: NCT04609878 — Phase 3
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