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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
Drug Has Already Been Approved
Pivotal Trial
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Oxygen Consumption (Max VO2)
Secondary study objectives
Airflow Limitation
Association between respiratory abnormalities and HRQOL outcomes.
Change in level of physical activity over time
+4 moreAwards & Highlights
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.
Trial 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
2,583 Previous Clinical Trials
15,179,071 Total Patients Enrolled
Flight Attendant Medical Research InstituteOTHER
12 Previous Clinical Trials
2,565 Total Patients Enrolled
Mehrdad Arjomandi, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
140 Total Patients Enrolled
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.
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