Status:
COMPLETED
Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
Lead Sponsor:
Aerocrine AB
Conditions:
Asthma
Eligibility:
All Genders
4-65 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and C...
Detailed Description
Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and incr...
Eligibility Criteria
Inclusion
- Children, and adults.
- A history of physician-diagnosed asthma or asthma diagnosed by a physician.
- Spirometry performed parameters.
- An increased FENO value.
- Symptomatic asthma as defined on the Asthma Control Questionnaire® (ACQ).
Exclusion
- Use of oral corticosteroids.
- Use of intranasal corticosteroids.
- Use of non-steroidal anti-asthma drugs.
- Current serious conditions and/or therapies that are confounding factors.
- Pregnancy.
- Other significant respiratory diseases and/or cardiovascular diseases.
- Current participation in another interventional clinical study.
- Inability to comply with the study procedures, e.g. spirometry and FENO measurements according to standard procedures.
- Unwillingness to sign informed consent and comply with treatment and visits.
- Smoking within 6 months before the study, or a smoking history of \>10 pack years or an equivalent amount of other tobacco use.
- Known alcohol or drug abuser.
- Food and beverage (other than water) intake within 1 hour before first FENO measurement
- Nicotine (including nicotine chewing gum, nicotine patch, snuff etc) use within 1 hour before first FENO measurement.
- Strenuous exercise within 1 hour before first FENO measurement
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00388570
Start Date
October 1 2006
End Date
July 1 2007
Last Update
November 4 2011
Active Locations (2)
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1
Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken
Höllviken, Sweden, SE-23651
2
Department of General Practice & Primary Care University of Aberdeen
Aberdeen, United Kingdom, AB252AY