Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment

NCT00388570 | Completed

• 1 other identifier: AER-036
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 2

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 Children.

Conditions

Asthma

Keywords

Asthma; adult; paediatric; NIOX MINO®; NIOX®; nitric oxide; airway inflammation; open-label; single-cohort

Outcome Measures

Primary Outcomes (2)

• The primary analysis variable will be the percent change in FENO measured with

• NIOX MINO® and NIOX® between Visit 1 to Visit 2.

Secondary Outcomes (7)

• Agreement between NIOX MINO® and NIOX® will be assessed by comparing

• individual pair-wise FENO measurements from visit V1.

• The change in FENO measured with NIOX MINO following corticosteroid therapy

• in asthma will be compared with improvements in standard asthma outcome

• measures (asthma symptoms and spirometry).

Interventions

The Aerocrine NIOX MINO® Airway Inflammation Monitor DEVICE

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerocrine AB: lead

Study Sites (2)

Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken

Höllviken, SE-23651, Sweden

Location

Department of General Practice & Primary Care University of Aberdeen

Aberdeen, AB252AY, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Price, Professor

  Dept of General Practice and Primary Care, University of Aberdeen

  STUDY CHAIR

• Sven-Erik Dahlén, Professor

  Unit for Experimental Asthma and Allergy Research Division of Physiology, The National Institute of Environmental Medicine Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 4, 2011

Record last verified: 2011-11

Locations

SE (1); GB (1)