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Secondhand Smoke Respiratory Health Study

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ClinicalTrials.gov Identifier: NCT02797275
Recruitment Status : Unknown
Verified July 2016 by University of California, San Francisco.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

Exposure to secondhand tobacco smoke (SHS) is associated with diverse health effects in nonsmokers. Flight attendants 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 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.


Condition or disease Intervention/treatment Phase
Secondhand Smoke Air Trapping Tobacco Airflow Limitation Hyperinflation Obstructive Lung Disease Drug: Albuterol Drug: Placebo Phase 4

Detailed Description:

The objective of this research plan is to investigate the hypothesis that subclinical airflow limitation and air trapping in never-smoking SHS-exposed individuals with preserved ratio impaired spirometry (PRISm) causes reduced exercise capacity . This in turn will adversely affect their symptoms and quality of life. Furthermore, we hypothesize that exercise capacity, symptoms, and quality of life will improve with the use of inhaled bronchodilators.

We proposed to investigate the above hypotheses through the following specific aims:

Aim 1- Determine whether airflow limitation in never-smoking SHS-exposed individuals with airflow limitation or air trapping is associated with reduced exercise capacity and adverse health and health-related quality of life (HRQL). We propose to measure (1) maximum level of exercise (watts) and maximum oxygen uptake (VO2) in the laboratory setting, (2) level of physical activity during the subjects' routine daily life using an activity monitor, and (3) measure HRQL using survey tools. We propose to then explore associations between these measures and indices of air trapping at rest (RV/TLC) and progressive airflow limitation with exercise (end expiratory lung volume [EELV] and dynamic hyperinflation [DH]).

Aim 2: Determine whether relief of airflow limitation using bronchodilators could improve exercise capacity in never-smoking SHS-exposed individuals with airflow limitation or air trapping in a double blind crossover placebo-controlled randomized clinical trial. We propose to examine the effect of bronchodilators on airflow limitation and air trapping and their effects in turn on exercise capacity, daily level of physical activity, and HRQL to show a cause-and-effect relationship. In this way, we plan to explore the utility of bronchodilators as a treatment option for the observed reduced exercise capacity.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lung Anatomic, Physiologic, and Inflammatory Changes With Chronic Exposure to Secondhand Tobacco Smoke
Study Start Date : March 2013
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Albuterol & Placebo
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
Other Name: ProAir

Drug: Placebo
Other Name: Placebo obtained from Teva

Experimental: Placebo & Albuterol
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
Other Name: ProAir

Drug: Placebo
Other Name: Placebo obtained from Teva




Primary Outcome Measures :
  1. Maximum Oxygen Consumption (Max VO2) [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Airflow Limitation [ Time Frame: 4 weeks ]
    After 30 minutes period of rest, the subject will perform exercise at increasing work rates corresponding to 20%, 40%, 60%, and 80% of the maximum oxygen uptake attained in the first exercise with 2 minutes at each stage. Inspiratory capacity will be measured 2 to 3 times at each work rate while recording tidal flow-volume loops to assess for evidence of airflow limitation during exercise. Air flow limitation will be determined by calculating the percent overlap of tidal breathing over expiratory portion of maximum flow.

  2. Dynamic Hyperinflation [ Time Frame: 4 weeks ]
    After 30 minutes period of rest, the subject will perform exercise at increasing work rates corresponding to 20%, 40%, 60%, and 80% of the maximum oxygen uptake attained in the first exercise with 2 minutes at each stage. Inspiratory capacity will be measured 2 to 3 times at each work rate while recording tidal flow-volume loops to assess for evidence of airflow limitation during exercise. Dynamic hyperinflation will be measured by changes in examining end-expiratory lung volume at each stage.

  3. Respiratory symptoms [ Time Frame: 4 weeks ]
    Respiratory symptoms will be assessed using CAT, SF-12, AQ-20, and IPAQ.

  4. Health-related quality of life [ Time Frame: 4 weeks ]
    HRQL will be measured by SF-12, AQ-20, and IPAQ.

  5. Level of physical activity [ Time Frame: 4 weeks ]
    Real world (outside lab) level of physical activity will be measured using an activity monitor (Actigraph) over a period of a week starting the third week during their treatment. The Actigraph is a monitor that allows collection and analysis of daily activity information about subjects in their normal daily living environment, which records both the number of steps and the time interval during which the steps are taken.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 FEV1/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
  2. Exclusion Criteria:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797275


Contacts
Contact: Mehrdad Arjomandi, M.D. 415-221-4810 ext 4393 mehrdad.arjomandi@ucsf.edu
Contact: Wendy Ching, B.S. 415-221-4810 ext 4009 wendy.ching@ucsf.edu

Locations
United States, California
VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Wendy Ching, BS    415-221-4810 ext 24009    wendy.ching@ucsf.edu   
Principal Investigator: Mehrdad Arjomandi, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Wendy Ching, B.S.    415-221-4810 ext 24009    wendy.ching@ucsf.edu   
Principal Investigator: Mehrdad Arjomandi, MD         
Sponsors and Collaborators
University of California, San Francisco
Flight Attendant Medical Research Institute
Investigators
Principal Investigator: Mehrdad Arjomandi, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02797275     History of Changes
Other Study ID Numbers: SHS
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action