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Beta-adrenoceptor Inverse Agonist
Nadolol for Asthma
Phase 2
Waitlist Available
Research Sponsored by Invion, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females with physician-diagnosed asthma between the ages of 18-60
Never-smoker or former-smoker < 10 pack.year and has not smoked within 1 year
Must not have
History of intubation for asthma
Currently taking any beta-blocker medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial will test if nadolol, a drug that blocks adrenaline, can help improve mild asthma by reducing airway hyperresponsiveness.
Who is the study for?
This trial is for adults aged 18-60 with mild asthma, who have good lung function and controlled asthma symptoms. Participants must not smoke, be pregnant or breastfeeding, and agree to use birth control if applicable. They should not have had a recent respiratory infection or hospitalization for asthma, nor should they take beta-blockers or have certain cardiovascular diseases.
What is being tested?
The study tests whether Nadolol, a beta-adrenoceptor inverse agonist, can improve airway responsiveness in patients with mild asthma over an 18-22 week period compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
Potential side effects of Nadolol may include slower heart rate, low blood pressure, fatigue, dizziness and could potentially worsen breathing problems in people with asthma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old with doctor-diagnosed asthma.
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I have never smoked or I quit smoking over a year ago and smoked less than 10 pack-years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been intubated for asthma in the past.
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I am currently taking beta-blocker medication.
Select...
I have diabetes or an overactive thyroid.
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I do not have uncontrolled high blood pressure or serious heart conditions.
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I was hospitalized for asthma in the last year.
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I have been diagnosed with COPD.
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I haven't taken any medication that is not allowed in the study recently.
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I cannot swallow pills.
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I do not have bleeding disorders and my blood clotting tests are within normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2015 Phase 2 trial • 155 Patients • NCT0182512227%
Dry mouth
9%
Diarrhoea
8%
Dysgeusia
5%
Nausea
4%
Headache
4%
Dizziness
3%
Abdominal pain upper
1%
Back pain
1%
Bipolar episode
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active, Nadolol
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active, nadololExperimental Treatment1 Intervention
Active
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nadolol
FDA approved
Find a Location
Who is running the clinical trial?
Invion, Inc.Lead Sponsor
3 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Asthma
10 Patients Enrolled for Asthma
Nicola A. Hanania, MD, MSStudy ChairBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently getting allergy shots.Your lung function is too sensitive to a test called methacholine challenge.Your blood pressure is higher than 110/65mm Hg before starting the trial.Your resting heart rate is at least 60 beats per minute.I have been intubated for asthma in the past.I am currently taking beta-blocker medication.I have diabetes or an overactive thyroid.Your asthma is not well controlled, based on a specific questionnaire score.Your blood tests must be mostly normal, but it's okay if your red blood cell count is at least 30%, platelet count is over 100,000, and liver enzyme levels are not too high.I do not have any health conditions that could affect my study participation or increase risk.I do not have uncontrolled high blood pressure or serious heart conditions.I was hospitalized for asthma in the last year.I have been diagnosed with COPD.I haven't taken any medication that is not allowed in the study recently.I am between 18 and 60 years old with doctor-diagnosed asthma.I have never smoked or I quit smoking over a year ago and smoked less than 10 pack-years.I am not pregnant, not breastfeeding, and will use birth control during the study.I cannot swallow pills.You are allergic to atropine or ipratropium bromide.You have had a bad reaction or allergy to any medication that is a beta-blocker.Your lung function (FEV1) is at least 80% of what is expected for someone your age and size before using a bronchodilator.You are currently struggling with alcoholism or drug abuse.I use my rescue inhaler more than twice a week, not counting before exercise.I haven't needed steroids for a respiratory issue or asthma in the last 6 weeks.I do not have bleeding disorders and my blood clotting tests are within normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Active, nadolol
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
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