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Bronchodilator
Albuterol for Secondhand Smoke Exposure
Phase 4
Waitlist Available
Led By Mehrdad Arjomandi, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will test if a bronchodilator can help improve airflow in never-smoking flight attendants with long-term exposure to secondhand tobacco smoke.
Who is the study for?
This trial is for never-smoking flight attendants exposed to secondhand smoke for over a year before the smoking ban on planes. They should have airflow limitations but not be diagnosed with overt COPD, and can't have used more than 100 cigarettes or joints in their lifetime. Participants must be able to exercise and not suffer from obesity (BMI >30), active heart disease, severe autoimmune diseases, or other lung-affecting conditions.Check my eligibility
What is being tested?
The study tests if Albuterol, a bronchodilator, can improve lung function in these individuals by comparing it with a placebo. It aims to confirm obstructive lung disease presence due to chronic SHS exposure and explore treatment options.See study design
What are the potential side effects?
Albuterol may cause side effects like jitteriness, headaches, rapid heartbeat, throat irritation and muscle cramps. Placebo has no active ingredients but some participants might report symptoms due to their expectations of the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Oxygen Consumption (Max VO2)
Secondary outcome measures
Airflow Limitation
Association between respiratory abnormalities and HRQOL outcomes.
Change in level of physical activity over time
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Placebo & AlbuterolExperimental Treatment2 Interventions
Participants will be placed on the placebo treatment after the completion of the baseline screening visit. They will use placebo for 4 weeks prior to their scheduled second visit during which they will undergo testing. Subsequently, and after a minimum washout period of 2 weeks, they will be placed on the albuterol treatment (2 puffs twice a day, equivalent to 360 mcg per day) for 4 weeks prior to their scheduled third visit, after which they will come back to undergo testing.
Group II: Albuterol & PlaceboExperimental Treatment2 Interventions
Participants will be placed on the albuterol treatment (2 puffs twice a day, equivalent to 360 mcg per day) after the completion of the baseline screening visit. They will use albuterol for 4 weeks prior to their scheduled second visit during which they will undergo testing. Subsequently, and after a minimum washout period of 2 weeks, they will be placed on the placebo treatment for 4 weeks prior to their scheduled third visit, after which they will come back to undergo testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albuterol
2012
Completed Phase 4
~2190
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,448 Total Patients Enrolled
12 Trials studying Tobacco Use
1,704 Patients Enrolled for Tobacco Use
Flight Attendant Medical Research InstituteOTHER
12 Previous Clinical Trials
2,565 Total Patients Enrolled
1 Trials studying Tobacco Use
647 Patients Enrolled for Tobacco Use
Mehrdad Arjomandi, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
140 Total Patients Enrolled
1 Trials studying Tobacco Use
40 Patients Enrolled for Tobacco Use
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body mass index (BMI) higher than 30, which is considered obese.You have a normal lung function test result.You have restricted airflow during breathing tests at the start of the study.Criterion: Flight attendants who have never smoked and have been exposed to secondhand smoke.You have used more than 100 marijuana joints in your lifetime, and have not used any in the past year.You have been exposed to secondhand smoke in an airplane cabin for more than 1 year while working for an airline.You have smoked more than 100 cigarettes in your life.You are not able to do the exercise tests.You have had treatments or illnesses that could have affected your lung function, like radiation therapy for breast cancer.You have a history of lung diseases like asthma, emphysema, chronic bronchitis, or others.You have smoked fewer than 100 cigarettes in your lifetime and haven't smoked any in the last year.You have used recreational drugs in the past.Your breathing test shows restricted airflow during exercise.Your lungs have a lot of air left in them after you breathe out.You have a history of serious heart problems or uncontrolled high blood pressure.You have a history of severe long-term illnesses like lupus or rheumatoid arthritis that greatly affect your daily life.
Research Study Groups:
This trial has the following groups:- Group 1: Albuterol & Placebo
- Group 2: Placebo & Albuterol
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 still opportunities for individuals to take part in this clinical research?
"Currently, this medical trial is not enrolling patients. Initially posted on July 1st 2014 and recently updated February 22nd 2022, it appears to have ceased recruitment at present; however, there are 389 other ongoing clinical trials recruiting participants."
Answered by AI
To what extent are participants benefitting from this research?
"Currently, this trial is not seeking any more volunteers. It was initially posted in July 2014 and modified as recently February 2022. However, there are 372 clinical trials related to tobacco research that are presently recruiting participants, plus 17 additional investigations for Albuterol open for recruitment."
Answered by AI
Could you explain the most common applications for Albuterol?
"Albuterol is a common therapeutic agent for exercise-induced bronchospasm, as well as other respiratory issues such as bronchodilator agents, infections in the airway and general bronchospasms."
Answered by AI
Has Albuterol been subject to other research endeavors?
"Presently, 17 clinical trials are available for Albuterol. Currently, none of these have reached Phase 3 status yet. The majority of research is centred in San Francisco but there are also 75 other locations around the United States conducting studies involving this medication."
Answered by AI
What characteristics should a participant possess to be a suitable candidate for this research endeavor?
"To be eligible for this clinical trial, candidates must have a history of smoking tobacco and are between the ages of 40 - 80. The research team is looking to recruit up to 107 participants."
Answered by AI
Is Albuterol compliant with Food and Drug Administration regulations?
"There is a wealth of clinical evidence to suggest Albuterol's safety, so it received an admirable score of 3."
Answered by AI
Is admission to the trial restricted to individuals within a certain age range?
"This clinical trial is geared towards patients aged 40 to 80. For those over 65 or under 18, there are 369 and 35 trials respectively available for them."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
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