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Mucolytic Agent
Hypertonic Saline for Asthma
N/A
Recruiting
Led By David Peden, MD, MS
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe asthma at baseline (determined by Step 3 therapy or greater or by asthma impairment) and well-controlled asthma at the time of enrollment, as determined by NHLBI Expert Panel Report 3 guidelines for diagnosis and treatment of asthma.
Age 18-60 of both genders-
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post-hs
Awards & highlights
Study Summary
This trial is testing whether a saltwater solution can help clear mucus from the airways of people with asthma.
Who is the study for?
This trial is for adults aged 18-60 with moderate to severe, well-controlled asthma. Participants must have an FEV1 of at least 70% of predicted without recent bronchodilator use and be vaccinated against Covid-19. Exclusions include allergies to study drugs, significant other medical conditions, recent acute infections or vaccinations, current smokers or those with a heavy smoking history, and certain medication uses.Check my eligibility
What is being tested?
The trial is testing whether inhaling hypertonic saline solutions (3% or 7%) can improve mucociliary clearance in asthmatics. It's designed to see if this treatment could help manage asthma symptoms by accelerating the removal of mucus from the airways.See study design
What are the potential side effects?
Potential side effects may include coughing, throat irritation, increased mucus production, and a salty taste following inhalation. There might also be temporary changes in lung function tests due to the saltiness of the inhaled solution.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate to severe asthma but it's well-controlled now.
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I am between 18 and 60 years old.
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I am between 18 and 60 years old.
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I am not pregnant or have had a hysterectomy with oophorectomy.
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My lung function test shows at least 70% of the expected value for someone my age, sex, height, and race.
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I am not pregnant or have had a hysterectomy with oophorectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes post-hs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post-hs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MCC from Baseline to Post Hypertonic Saline Inhalation
Secondary outcome measures
Effects of HS on MCC by testing
The proportion of moderate to severe asthmatics who are deemed 'intolerant' to HS
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hypertonic SalineExperimental Treatment2 Interventions
Subjects will inhale hypertonic saline before having a Mucociliary Clearance (MCC) scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3% Hypertonic Saline
2013
N/A
~60
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,010 Total Patients Enrolled
30 Trials studying Asthma
2,197 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,603 Total Patients Enrolled
276 Trials studying Asthma
112,527 Patients Enrolled for Asthma
David Peden, MD, MSPrincipal InvestigatorCEMALB
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been intubated for asthma in the past.I have moderate to severe asthma that is currently well-controlled.I haven't taken any anti-inflammatory drugs in the last 4 days.I have taken theophylline daily in the last month.I haven't taken any immune system altering drugs in the last year.I am taking beta blocker medications.My lung function test shows I can breathe out well without recent medication.I am not taking medications that could affect the study results.I am not willing to use birth control or condoms if I'm sexually active.I had a cold or similar virus in the last 4 weeks.I have not taken antibiotics for an infection in the last 4 weeks.I am not pregnant and I am 18 years or older.I am not allergic to albuterol, diphenhydramine, or corticosteroids.I have moderate to severe asthma but it's well-controlled now.I can skip my morning lung medication on treatment days.I am between 18 and 60 years old.I am not allergic to the drugs used in this study.I have not been exposed to radiation levels above safety guidelines in the past year.I have not had the FluMist or any vaccine in the last 30 days.I am between 18 and 60 years old.I am not pregnant or have had a hysterectomy with oophorectomy.You have a mental illness or a history of drug or alcohol abuse that might make it hard for you to follow the study rules.Your blood pressure is too high (above 150/90) or too low (below 90/50).Any unusual sounds when the doctor listens to your lungs.I do not have chronic conditions that my doctor thinks would make the study unsafe for me.My lung function test shows at least 70% of the expected value for someone my age, sex, height, and race.I have not taken multivitamins, Vitamin C or E, or herbal medications in the last 4 days.I am not pregnant or have had a hysterectomy with oophorectomy.I have smoked or used e-cigarettes within the last year or have a history of heavy smoking.I do not rely on systemic corticosteroids for asthma.Your body temperature is higher than 37.8 degrees Celsius.Your blood oxygen level is less than 93%.You tested positive for Covid-19 in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Hypertonic Saline
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for individuals to join this investigation?
"As per records on clinicaltrials.gov, the current recruitment phase of this medical trial has been ongoing since it was first published in October 2018 and last updated in January 2022."
Answered by AI
Am I eligible to partake in this experimental research?
"Eligible participants for this trial must have asthma and be in between 18-60 years old. The researchers are aiming to recruit a total of 24 members."
Answered by AI
Is the eligibility criteria for this trial limited to those under eighty years of age?
"The parameters for taking part in this trial are that applicants must be at least 18 and no older than 60 years of age."
Answered by AI
How many individuals are being selected to partake in this experiment?
"Affirmative. The clinicaltrial.gov portal indicates that this research project is currently searching for participants; it was originally listed on October 1st 2018 and its details were most recently revised on April 1st 2022. There are 24 slots available at one site of the study's location plan."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Center for Environmental Medicine, Asthma and Lung Biology
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Center for Environmental Medicine, Asthma and Lung Biology: < 24 hours
Average response time
- < 1 Day
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