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Corticosteroid
New Propellant Inhaler for Asthma
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a pre-dose FEV1 of ≥ 60% and < 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1
Participant must be ≥ 18 years of age at the time of signing the ICF
Must not have
Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease
Life-threatening asthma episode(s) requiring intensive care unit admission, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at day 29
Awards & highlights
Pivotal Trial
Summary
This trial aims to compare how well an approved asthma medication works when it is delivered using a new type of propellant called HFO, versus the current propellant called HFA, in people with asthma
Who is the study for?
This trial is for individuals with asthma. Participants should be stable on their current asthma medications and have a history of the disease. Specific details about inclusion or exclusion criteria are not provided, but typically these would cover age range, severity of asthma, and any other health conditions that might affect safety or results.
What is being tested?
The study is testing the effectiveness of an approved asthma medication (BDA) using a new propellant (HFO), compared to the same medication with its current propellant (HFA). The goal is to see if lung function remains consistent when switching propellants in inhalers.
What are the potential side effects?
While specific side effects are not listed for this trial, common side effects from BDA inhalers may include throat irritation, headache, coughing, and possibly an increased heart rate. The change in propellant may also bring unforeseen reactions which this trial aims to uncover.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function, measured by FEV1, is between 60% and 90% of the expected value and stable.
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I am 18 years old or older.
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My lung function, measured before using a bronchodilator, is between 60% and 90% of the expected normal.
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My lung function improves significantly after using a short-acting bronchodilator.
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I am not able to have children or I am using birth control.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with COPD or another serious lung condition.
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I've had a severe asthma attack requiring ICU care in the last 5 years.
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My asthma symptoms got worse during the trial's observation period.
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My cancer cannot be removed by surgery and has not been in complete remission for 5 years.
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I had a severe asthma attack recently.
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I haven't taken steroids for breathing, immune, or allergy issues in the last 6 months.
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I had an upper respiratory infection that needed antibiotics and it hasn't cleared up in the last 7 days.
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I have had a lung infection in the last month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at day 29
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 peak FEV1 in 0-60 minutes after dosing at Day 29
Secondary study objectives
Change from baseline in morning pre-dose trough FEV1
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: BDA MDI HFOActive Control1 Intervention
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO
Group II: BDA MDI HFAActive Control1 Intervention
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA
Group III: Placebo MDI HFAPlacebo Group1 Intervention
Placebo pressurized inhalation suspension, HFA
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,213 Total Patients Enrolled
351 Trials studying Asthma
654,903 Patients Enrolled for Asthma