Albuterol for Secondhand Smoke Exposure

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Cardiac disease, Hypertension, Respiratory diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if albuterol, a medication often used for asthma, can improve lung function in flight attendants exposed to secondhand smoke before smoking was banned on planes. The researchers seek to find out if albuterol can alleviate breathing problems in those who have never smoked but still show signs of lung issues. Eligible participants should be former flight attendants who worked in smoky airplane cabins for over a year and have never smoked more than 100 cigarettes in their lifetime. Participants will receive both albuterol and a placebo (a non-active substance) to compare effects. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how albuterol benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Albuterol?

Research shows that albuterol, the treatment under study, has been used for many years to help with breathing problems and is generally considered safe. Some studies indicate it can cause minor side effects, but these are usually not serious. Albuterol improves airflow and breathing, especially in people exposed to secondhand smoke. Since this trial is in Phase 4, albuterol has already received FDA approval for other uses, indicating that its safety is well understood. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for issues related to secondhand smoke exposure focus on minimizing exposure or managing symptoms with general medications. However, researchers are exploring albuterol, typically used for asthma, as a direct treatment option. Albuterol is unique because it acts as a bronchodilator, helping to open up airways and improve breathing by relaxing the muscles in the lungs. This mechanism could offer a more targeted approach to alleviate breathing difficulties caused by secondhand smoke. Researchers are excited about its potential to provide rapid relief compared to standard symptom management options, which often don't address the specific respiratory effects of secondhand smoke.

What evidence suggests that albuterol might be an effective treatment for secondhand smoke exposure?

Research has shown that albuterol can aid individuals with breathing problems caused by secondhand smoke. In studies, albuterol improved breathing and exercise capacity in those with lung issues from secondhand smoke, even without severe lung disease. This trial will assess albuterol's effectiveness in enhancing airflow and reducing trapped air in the lungs. Participants will receive albuterol in one phase and a placebo in another, enabling researchers to compare the effects. Albuterol may help open the airways, making breathing easier. Thus, even without serious lung damage, albuterol could improve breathing and activity levels for those exposed to secondhand smoke. ^{1 2 3 6 7}

Who Is on the Research Team?

Mehrdad Arjomandi, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion Criteria

You have a body mass index (BMI) higher than 30, which is considered obese.

You have used more than 100 marijuana joints in your lifetime, and have not used any in the past year.

You have smoked more than 100 cigarettes in your life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either albuterol or placebo treatment for 4 weeks, followed by a crossover to the alternate treatment after a 2-week washout period

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in physical activity, respiratory function, and quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Albuterol
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo & Albuterol Experimental Treatment 2 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 & Placebo Experimental Treatment 2 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.

Albuterol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Albuterol for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchospasm

Approved in European Union as Salbutamol for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchospasm

Approved in Canada as Salbutamol for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Exercise-induced bronchospasm

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Flight Attendant Medical Research Institute

Collaborator

Trials

13

Recruited

2,700+

Published Research Related to This Trial

A study involving 10 healthy volunteers found no significant differences in lung bioavailability between generic (Salamol, Salbulin) and innovator (Ventolin) formulations of inhaled salbutamol, indicating similar effectiveness in delivering the medication to the lungs.

All formulations produced comparable plasma salbutamol levels and urinary excretion rates, suggesting that both generic and innovator inhalers can be used interchangeably without loss of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung bioavailability of generic and innovator salbutamol metered dose inhalers. Clark, DJ., Gordon-Smith, J., McPhate, G., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10799390/

Effect of twice daily inhaled albuterol on cardiopulmonary ... Albuterol may improve ventilation and exercise capacity in secondhand tobacco-exposed persons with preserved spirometry and lung volumes suggestive of air ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38245665/

Effect of twice daily inhaled albuterol on cardiopulmonary ... Conclusions: Albuterol may improve exercise capacity in the subgroup of SHS tobacco-exposed persons with preserved spirometry and substantial ...

3. withpower.com withpower.com/trial/phase-4-lung-diseases-6-2014-9d6d0

Albuterol for Secondhand Smoke Exposure A study involving 10 healthy volunteers found no significant differences in lung bioavailability between generic (Salamol, Salbulin) and innovator (Ventolin) ...

4. pulmonologyadvisor.com pulmonologyadvisor.com/news/secondhand-smoke-exposure-exercise-capacity-albuterol/

Albuterol May Improve VO 2 in Some People With ... Albuterol may improve ventilation and exercise capacity in individuals exposed to secondhand tobacco smoke (SHS) who have preserved spirometry and lung volumes.

5. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02808-7

Effect of twice daily inhaled albuterol on cardiopulmonary ... Albuterol may improve exercise capacity in the subgroup of SHS tobacco-exposed persons with preserved spirometry and substantial air trapping.

6. uc.edu uc.edu/news/articles/n20943607/uc-study-secondhand-smoke-sends-more-kids-to-the-hospital.html

UC study: Secondhand smoke sends more kids to the ... Children exposed to tobacco smoke were 24 times more likely to be admitted to the hospital than unexposed children, which Merianos says ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524002572

Secondhand smoke exposure and asthma status among ... This study compares the prevalence of secondhand tobacco and marijuana smoke exposure, overall and by asthma status, among middle and high school students.