Recruiting

Breath Analyzer

Sponsor:

Ekips Technologies

Code:

NCT00386737

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

Annually, asthma is responsible for 1 million emergency room visits, 400,000 hospitalizations, and 5000 deaths according to the NHLBI. In addition, 10 million missed school-days per year and 100 million days of restricted activity are attributed to this disease. While there is no known cause or cure for asthma, recent studies have shown that hospitalizations and emergency room visits can be reduced by as much as 78% and 73%, respectively, when the disease is properly managed. According to the EPA, the occurance of children with asthma more than doubled the rate of two decades ago; in 2001 the percentage of asthmatic children was 8.7% (6.3 million children).

Properly managing asthma is nontrivial and can often require an asthma specialist. The difficulty in diagnosing and managing asthma lies primarily in the lack of available clinical technologies capable of assessing airway inflammation, an early and persistent component of asthma. Accordingly, the National Institutes of Health (NIH) guidelines for the diagnosis and management of asthma strongly recommend long term anti-inflammatory therapies, such as oral or inhaled corticosteroids, to reverse airway inflammation in an effort to prevent irreversible airway damage, termed "airway remodeling". The medical community has expressed the need for more objective and noninvasive measures of airway inflammation for diagnosing asthma and monitoring the effectiveness and compliance of anti-inflammatory therapies.

The clinical research plan is designed to evaluate airway inflammation associated with asthma. In this human subjects study, a non-invasive exhaled breath analysis sensor, called the Breathmeter, will be used to measure eNO concentrations in children and adults (ages 4-65) with a broad range of respiratory disorders as well as those with no known respiratory disorders. Breath donations will be simple and straightforward presenting little to no discomfort to volunteers.

Conditions

Asthma

Study ID

NCT00386737

Start date

Sep, 2004

Status verified date

Oct, 2006

Completion date

Feb, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy subjects (n=120)
  • Asthma (Total n=450) \[diagnosed according to NHLBI/ NAEPP Guidelines (1998)\]

  • Non-treated or B2-agonist treated asthmatics (n=150),
  • Glucocorticoid treated asthmatics, (n=150),
  • Leukotriene Antagonist treated asthmatics, (n=75),
  • Glucocorticoid and Leukotriene Antagonists treated asthmatics, (n= 75).
  • Acute respiratory illnesses (n=65

  • Sinusitis (Acute and Chronic),
  • Influenza,
  • Common cold,
  • Pneumonia,
  • Related symptoms, but no diagnosis.
  • Allergies (n=65)

  • Atopic dermatitis,
  • Allergic rhinitis,
  • Seasonal allergies.

Exclusion Criteria:

  • Younger than 4
  • Older than 65
  • Pregnant

Study Design

Enrollment

2000 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Locations

Ekips Technologies, Inc.

Recruiting

Norman, Oklahoma, United States, 73069

Contacts

More Information

Sponsor

Ekips Technologies

Last update posted

Oct 12, 2006

Last verified

Oct, 2006

Keywords

  • Asthma
  • Breath Testing
  • Laser Spectroscopy
  • eNO
  • Nitric Oxide
  • Lower Airway Inflammation
  • Carbon Dioxide
  • CO2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ekips Technologies on 2006-10-12.