Secondhand Smoke Respiratory Health Study

NCT02797275 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: SHS13631
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Secondhand Smoke; Air Trapping; Tobacco; Airflow Limitation; Hyperinflation; Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• Maximum Oxygen Consumption (Max VO2)

  Maximum oxygen consumption (Max VO2) as determined by a symptom-limited progressively increasing cycle exercise test to determine the maximum work (watts) and oxygen uptake (VO2) achieved. The protocol consisted of 3-min rest, 1-min unloaded (freewheeling) cycling at 60 rpm, followed by increasing work rate of 20-30 Watts each 2 minutes to a maximum tolerated, and 5-min of recovery. Twelve lead ECGs were monitored continuously and were recorded along with BP every 2 min. Oxyhemoglobin saturation (O2sat) determined by pulse oximetry was recorded continuously.

  4 weeks

Secondary Outcomes (7)

• Airflow Limitation

  4 weeks

• Dynamic Hyperinflation

  4 weeks

• Change in scores on the SF-12® Health Survey Short Form (SF-12)

  Up to 12 months

• Change in scores on the Airway questionnaire (AQ20)

  Up to 12 months

• Change in scores on the International Physical Activity Questionnaires (IPAQ)

  Up to 12 months

Study Arms (2)

Albuterol & Placebo

EXPERIMENTAL

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.

Drug: Albuterol; Drug: Placebo

Placebo & Albuterol

EXPERIMENTAL

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.

Drug: Albuterol; Drug: Placebo

Interventions

Albuterol DRUG

Beta agonist respiratory inhaler

Also known as: ProAir

Albuterol & Placebo; Placebo & Albuterol

Placebo DRUG

respiratory inhaler with no medication

Also known as: Placebo obtained from Teva

Albuterol & Placebo; Placebo & Albuterol

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Never Smoking SHS-exposed Flight Attendants:
• aircraft cabin SHS exposure of \>1 year while working for airlines
• Never smoker as defined by use of \<100 cigarettes lifetime and none within the last year.
• Normal forced expiratory volume (FEV) FEV1/ forced vital capacity (FVC) ratio
• One of the following evidence of airflow obstruction:
• Presence of any airflow limitation on spirometry during the baseline visit
• Development of airflow limitation on spirometry during any stages of exercise testing
• Residual volume to total lung capacity ratio of \>0.35

You may not qualify if:

• History of active cardiac disease, uncontrolled hypertension, congestive heart failure
• History of direct tobacco use of over 100 cigarettes in their lifetime
• History of established respiratory diseases such as asthma, emphysema, chronic bronchitis, interstitial lung disease, or sarcoidosis
• History of debilitating chronic illnesses such as severe lupus or rheumatoid arthritis
• History of other illnesses or therapy for illnesses that could affect lung function such as radiation therapy for breast cancer
• Physical inability to perform exercise testing
• BMI \>30 kg/m2
• History of marijuana use of \>100 joints lifetime, and none within the last year
• History of other recreational drug use

Sponsors & Collaborators

• University of California, San Francisco: lead
• Flight Attendant Medical Research Institute: collaborator

Study Sites (2)

VA Medical Center

San Francisco, California, 94121, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Interventions

Albuterol; Procaterol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mehrdad Arjomandi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: June 13, 2016
• Study Start: June 6, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)