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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

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 more

Awards & 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