Albuterol for Secondhand Smoke Exposure

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

107 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Albuterol for secondhand smoke exposure?

Research shows that salbutamol (another name for Albuterol) is effective in improving lung function in conditions like asthma and COPD (chronic obstructive pulmonary disease), which suggests it may help with breathing issues caused by secondhand smoke exposure. ^{1 2 3 4 5}

Is albuterol (salbutamol) generally safe for humans?

Albuterol (salbutamol) has been used for many years to help with breathing problems and is generally considered safe. Some studies have shown minor side effects like changes in heart rate and tremors, but these are usually not serious. ^{6 7 8 9 10}

How does the drug Albuterol differ from other treatments for secondhand smoke exposure?

Albuterol is unique because it is a fast-acting bronchodilator (a drug that helps open the airways) commonly used for asthma and other respiratory issues, and it may help alleviate airway constriction caused by secondhand smoke exposure. Unlike other treatments, it works by relaxing the muscles in the airways, making it easier to breathe. ^{1 5 11 12 13}

What is the purpose of this trial?

Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in nonsmokers. Flight attendants (FA) who worked on commercial aircraft before the ban on tobacco smoking (exposed FAs) had high, long-term levels of occupational exposure to SHS and are a unique population for the study of long-term health effects of chronic exposure to SHS. In previous studies, we have shown that many never-smoking SHS-exposed FAs to have curvilinear flow-volume loops, decreased airflow at mid- and low-lung volumes, and static air trapping (elevated residual volume to total lung capacity ratio \[RV/TLC\]), abnormalities that are not diagnostic of overt Chronic Obstructive Pulmonary Disease (COPD), but do implicate the presence of an obstructive ventilatory defect, and are consistent with what has been recently described as preserved ratio impaired spirometry (PRISm). The main objective of the study is to determine the effect of a bronchodilator to counter the physiologic abnormalities that are observed in the population of never-smoking SHS-exposed FAs as both proof of concept of the presence of an obstructive lung disease and as a possible therapeutic option to counteract the adverse respiratory effects of chronic exposure to SHS.

Research Team

Mehrdad Arjomandi, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-life effectiveness and safety of salbutamol Steri-Neb™ vs. Ventolin Nebules® for exacerbations in patients with COPD: Historical cohort study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Inhaled formoterol during one year in asthma: a comparison with salbutamol. [2015]

3. Serbia pubmed.ncbi.nlm.nih.gov

[Evaluation of the bronchodilator test]. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and tolerance of a 12-week treatment with inhaled formoterol in patients with reversible obstructive lung disease. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Airway responses to salbutamol after exposure to chemical warfare. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Safety outcomes of salbutamol: A systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Albuterol syrup in the treatment of the young asthmatic child. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Dose-response study with high-dose inhaled salmeterol in healthy subjects. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Experiences with large doses of beta 2-agonists inhaled from nebulizers. [2013]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Docking guided phase display to develop fusion protein with novel scFv and alkaline phosphatase for one-step ELISA salbutamol detection. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Bronchodilator effects of antiasthmatic cigarette smoke (Datura stramonium). [2019]

12. England pubmed.ncbi.nlm.nih.gov

Lung bioavailability of generic and innovator salbutamol metered dose inhalers. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Change in Oxygen Consumption Following Inhalation of Albuterol in Comparison with Levalbuterol in Healthy Adult Volunteers. [2018]