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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Genetic Susceptibility to Ozone in Mild Asthmatic Volunteers

Short name Glutoz

NCTNCT00287365 (opens ClinicalTrials.gov in a new tab)Other idGCRC-2371Other idNCCAM 1PO1AT002620
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Not applicable
Enrollment
25 participants (actual)
Sponsor
University of North Carolina, Chapel Hill · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jan 2006
Primary completion
Nov 2015
Completion
Nov 2015
First posted
6 Feb 2006 (estimated)
Last update posted
13 Oct 2017
Conditions
Mild Asthma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620082010201220142016
  1. N/A

    Glutoz

    NCT00287365

    Jan 2006 to Nov 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Recent reports have shown that people with asthma who have a particular gene, known as the GSTM1 null gene, are more susceptible to the effect of air pollutants. The purpose of this research study is to learn if volunteers who have asthma and have a GSTM1 null gene have increased response (change in lung function and increase in lung cells collected from sputum) compared to volunteers with asthma who have the GSTM1 sufficient gene when challenged with 0.4 ppm ozone during intermittent exercise. The principal purpose of this study is to identify hyper-responsive, responsive and non-responsive groups of human subjects with mild asthma based on their airway neutrophilic response to ozone exposure, and to perform analyses on DNA from airway cells to explore possible differences in genetic profiles between the three groups. An additional pilot aim is to compare expression of a small number of specific genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects with mild asthma.

Interventions

  • ozoneDrug

Arms1

  • Experimental

    1-ozone

    Mildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

    Time frame · 6 hours post exposure

Secondary outcomes(2)

  1. Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

    Time frame · 6 hours post exposure

  2. % Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

    Time frame · 6 hours post exposure

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 hours post exposure

Post Ozone Change in Lung Function (FEV1) Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

GroupValue (percentage of FEV1 predicted)Spread
GSTM1 Null856
GSTM1 Sufficient796
Secondary and other outcome results(2)
Secondary outcomeMean· 6 hours post exposure

Secondary Endpoints Include Post Ozone Airway PMN Influx Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

GroupValue (percentage of cells)Spread
GSTM1 Null48
GSTM1 Sufficient816
Secondary outcomeMean· 6 hours post exposure

% Decrease in FVC in Asthmatics Between Subjects With GSTM1 Null Genotype Compared to GSTM1 Sufficient Subjects

GroupValue (percentage of FVC predicted)Spread
GSTM1 Null935
GSTM1 Sufficient854

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Mildly Asthmatic Subjects With GSTM1 Null Genotype Compared toMildly asthmatic subjects with GSTM1 null genotype compared to GSTM1 sufficient subjects ozone: 2 hour exposure to 0.4 ppm ozone–0 / 252 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * healthy volunteers with mild asthma * Normal lung function, * Oxygen saturation of \> 94 % * Normal blood pressure Exclusion Criteria: * A history of significant chronic illnesses * Allergy to any medications which may be used or prescribed in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol) * Positive pregnancy test within 48 hours of the time of challenge * Subjects currently taking medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics). * Mega doses of vitamins and supplements, homeopathic/naturopathic medicines * Any acute, non-chronic, medical conditions occurring in the prior two weeks. Such illnesses must be totally resolved symptomatically for 2 weeks and documentation of normal lung function must be obtained. * Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with ozone inhalation challenge, will be a basis for exclusion. * Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. * Use of systemic steroid therapy within the preceding 12 months. * \> 0.5 pack year history of tobacco use * Use of inhaled steroids, cromolyn or leukotriene inhibitors initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy. * Use of daily theophylline within the past month. * Pregnancy or nursing a baby. * Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. * Exacerbation of asthma more than 2x/week which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. * Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). * Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Use of inhaled steroid at doses typically used for moderate or severe asthma will result in exclusion of that individual from the protocol. * Students or staff members who work directly for the PI, Dr David Peden, are excluded from study participation

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