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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study 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.Check my eligibility
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).See study design
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit.

Side effects data

From 2015 Phase 2 trial • 155 Patients • NCT01825122
27%
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

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

Nadolol (Beta-adrenoceptor Inverse Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT01804218 — Phase 2
Asthma Research Study Groups: Active, nadolol, Placebo
Asthma Clinical Trial 2023: Nadolol Highlights & Side Effects. Trial Name: NCT01804218 — Phase 2
Nadolol (Beta-adrenoceptor Inverse Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01804218 — Phase 2

Frequently Asked Questions

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

What is the aggregate participant count of this research endeavor?

"Unfortunately, this clinical trial is no longer accepting patients. Initially posted on March 1st 2013 and updated August 5th 2016, it has been retired from the list of active research studies. However, if you are still seeking medical trials for asthma, 318 options remain open to you and 3 studies exist that require Nadolol participants."

Answered by AI

Does this research endeavor accept participants over a quarter-century of age?

"According to the requirements of this clinical trial, only individuals aged 18 through 60 are eligible for participation. There are 112 trials specifically targeting those younger than 18 years old and 200 applicable to senior citizens over 65."

Answered by AI

Are there other precedent studies that have assessed the efficacy of Nadolol?

"Presently, there are 3 ongoing investigations into the effects of Nadolol and none have entered Phase 3. Notably, Houston has a number of research sites conducting trials with 5 in total."

Answered by AI

What is the most common application of Nadolol?

"Nadolol has proven to be a successful medication for treating migraine, but it can also offer relief from other medical issues, such as atrial fibrillation, gastroesophageal variceal hemorrhage prophylaxis and thyrotoxicosis."

Answered by AI

Are there any specific prerequisites for being eligible to join this clinical trial?

"This medical trial is seeking 60 participants aged 18 to 60 years old who have been diagnosed with asthma. To be considered, applicants must satisfy the following criteria: demonstrate a negative pregnancy test (for females of childbearing age), register an Asthma Control Questionnaire Score of less than 1.25, maintain a pulse rate of at least sixty beats per minute, not smoked for more than one year and had no history smoking exceeding ten pack-years as well as being willing to record daily diary entries and comply with protocol procedures throughout the study's duration."

Answered by AI

Is this a pioneering clinical trial?

"Since 2013, there has been an increasing body of research into nadolol. After the first trial involving 60 patients and funded by Invion, Inc., it was greenlit to move onto its Phase 2 drug approval process. Currently 3 studies are being conducted across 4 cities in 1 country."

Answered by AI

Does Nadolol present any potent hazards to users?

"After assessing the clinical data, our team has assigned Nadolol a safety rating of 2. This Phase 2 trial provides evidence that this medication is safe to use in humans but there are no studies yet confirming its efficacy."

Answered by AI

Is this medical trial currently recruiting participants?

"According to the information published on clinicaltrials.gov, this research is not actively recruiting patients; it was first posted in March of 2013 and last updated in August 2016. Nevertheless, there are currently 321 other trials searching for enrollees at present."

Answered by AI
~5 spots leftby Apr 2025