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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight ≥ 40 kg and body mass index < 35 kg/m2
Able and willing to undertake bronchoscopy
Must not have
Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
History of malignancy other than superficial basal cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Summary
"This trial aims to see how a new medication, AZD4604, affects airway inflammation and specific signaling pathways in people with moderate-to-severe asthma, compared to a placebo. Participants will be
Who is the study for?
This trial is for adults with moderate-to-severe asthma who are interested in testing a new treatment. Participants should be available for about 10 weeks and willing to take the study medication or placebo for around 4 weeks.
What is being tested?
The trial is evaluating AZD4604, a potential new asthma medication, against a placebo. The focus is on how well AZD4604 can reduce airway inflammation compared to no active treatment over a period of four weeks.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with asthma treatments may include throat irritation, headache, coughing, and possible reactions at the site of administration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 40 kg and my BMI is under 35.
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I am willing and able to undergo a bronchoscopy procedure.
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I am a woman who cannot become pregnant due to surgery or menopause.
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I have a negative pregnancy test result.
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I've had a severe asthma attack in the last year or my asthma control score is poor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had recent hepatitis, unexplained jaundice, or been treated for hepatitis B, C, or HIV.
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I have had cancer before, but it wasn't just a minor skin cancer.
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I haven't taken any immunosuppressive drugs in the last 12 weeks.
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I haven't had immunotherapy in the last 6 months.
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I currently smoke or have smoked a lot in the past.
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A close family member had lung cancer.
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I do not have any serious heart or brain blood vessel problems.
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I have a significant lung condition that is not asthma.
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I have had blood clots in my veins before.
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I haven't used inhaled steroids or quick-relief inhalers recently.
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I am currently pregnant or breastfeeding.
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I haven't had major surgery in the last 8 weeks and don't plan any soon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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 to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings
Secondary outcome measures
Change from baseline to end of IMP administration in STAT phosphorylation in bronchial biopsies
Change in number of airway cells, including but not limited to inflammatory cells, airway smooth muscle cells, and goblet cells from baseline to end of IMP administration in bronchial biopsies (cells per mm² determined by microscopic evaluation)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD4604Experimental Treatment1 Intervention
AZD4604
Group II: Placebo to AZD4604Placebo Group1 Intervention
Placebo to AZD4604
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,761 Total Patients Enrolled
344 Trials studying Asthma
659,918 Patients Enrolled for Asthma
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