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NCT02797275 · ClinicalTrials.gov registry record · Phase 4

Secondhand Smoke Respiratory Health Study

A Phase 4 study of Tobacco and Secondhand Smoke, sponsored by University of California, San Francisco.

Active
Registry status
Phase 4
Development phase
107
Enrollment target
2
Study locations

NCT02797275: Active Phase 4 study of Tobacco and Secondhand Smoke, sponsored by University of California, San Francisco.

NCT02797275 is a Phase 4 study of Tobacco and Secondhand Smoke that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 107 participants, below the 119-participant average among 3 other Tobacco trials with a reported enrollment target (10% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02797275, a Phase 4 study of Tobacco and Secondhand Smoke, is active but no longer recruiting, sponsored by University of California, San Francisco.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
107 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

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

Interventions

  • DRUG Placebo
  • DRUG Albuterol

Study Locations (2)

California

  • VA Medical Center - San Francisco
  • University of California San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2016-06-06
Est. Completion 2025-12-31
Phase Phase 4

What the registry record for NCT02797275 still lists

NCT02797275 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 119-participant average among 3 other Tobacco trials with a reported enrollment target (10% lower).

The record links to 6 conditions, with Tobacco appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02797275 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT02797275 about?

NCT02797275 is a clinical study titled "Secondhand Smoke Respiratory Health Study". 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 ...

What is the current status of trial NCT02797275?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 107 participants. The study started on 2016-06-06. Estimated completion is 2025-12-31.

What conditions does trial NCT02797275 study?

This clinical trial studies the following conditions: Tobacco, Secondhand Smoke, Hyperinflation, Air Trapping, Airflow Limitation.

What interventions are being tested in trial NCT02797275?

The interventions under investigation include: Placebo (DRUG), Albuterol (DRUG).

Who is sponsoring clinical trial NCT02797275?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02797275 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02797275, the US trial registry maintained by the National Library of Medicine. NCT02797275 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.