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Secondhand Smoke Respiratory Health Study

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ClinicalTrials.gov Identifier: NCT02797275
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
Mehrdad Arjomandi, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE July 1, 2015
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Pulmonary Function Test [ Time Frame: Baseline ]
A full pulmonary function test will be completed during the baseline visit. This will enable us to measure their lung function. The multiple variables (FEV1, FVC, FEV1/FVC, TLC, and etc.) will be assessed to determine if there are any evidence of air trapping or obstructive airway for all participants in the study.
Change History Complete list of historical versions of study NCT02797275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • 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.
  • 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.
  • Respiratory symptoms [ Time Frame: 4 weeks ]
    Respiratory symptoms will be assessed using CAT, SF-12, AQ-20, and IPAQ.
  • Health-related quality of life [ Time Frame: 4 weeks ]
    HRQL will be measured by SF-12, AQ-20, and IPAQ.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2016)
Maximum Effort Exercise Capacity [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
A full Exercise Test will be completed during the baseline visit. In addition, the same set of tests will also be completed after 4 weeks and 8 weeks. Based on the medications (placebo/albuterol) that they receive, this will enable us to measure any improvements with their heart and lung function through the measurement of the subject's blood pressure, heart rate, maximum workload completed and anaerobic threshold.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Secondhand Smoke Respiratory Health Study
Official Title  ICMJE Lung Anatomic, Physiologic, and Inflammatory Changes With Chronic Exposure to Secondhand Tobacco Smoke
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Secondhand Smoke
  • Air Trapping
  • Tobacco
  • Airflow Limitation
  • Hyperinflation
  • Obstructive Lung Disease
Intervention  ICMJE
  • Drug: Albuterol
    Beta agonist respiratory inhaler
    Other Name: ProAir
  • Drug: Placebo
    respiratory inhaler with no medication
    Other Name: Placebo obtained from Teva
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Albuterol
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Albuterol
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2016)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mehrdad Arjomandi, MD 415-221-4810 ext 4393 mehrdad.arjomandi@ucsf.edu
Contact: Melissa Nishihama, BA 415-221-4810 ext 25062 melissa.nishihama@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02797275
Other Study ID Numbers  ICMJE SHS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mehrdad Arjomandi, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Flight Attendant Medical Research Institute
Investigators  ICMJE
Principal Investigator: Mehrdad Arjomandi, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP