Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age

NCT01729247 | Completed Results

• 1 other identifier: AER-043
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions. Secondary objectives: Evaluate the ability of physicians to correctly assess airway inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement). Estimate the cost consequences of changes in asthma management following FeNO determinations Number of participants: Approximately 40 to 50 subjects will participate in the study during an (approximately) 8-12 week study enrollment period. Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4) FeNO has been measured and seen by the Physician/Health Care Practitioner. Safety assessments: The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan (CIP) from the time that informed consent has been provided and during the study period Criteria for evaluation: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may be used to design subsequent studies in subjects with asthma. Data collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• FeNO Values by ACT Score

  Scores on an asthma control test (ACT) of \<=19 indicates less well controlled asthma, scores \>19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.

  Study Visit (single visit study). Approximately 1 hour.

• FeNO Categorical Levels by ICS Use

  Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (\<25 ppb), intermediate (\>=25 to \<=50 ppb) and high (\>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.

  Study visit (single visit study). Approximately1 hour.

Secondary Outcomes (3)

• Physician Assessment of Airway Inflammation

  Study visit (single visit study) approximately 1 hour

• Number of Participants Correctly Categorized by True Level of Airway Inflammation

  Study visit (single visit study) approximately 1 hour.

• Asthma Management Changes After FeNO Results Were Considered

  Study visit (single visit study). Approximately1 hour.

Study Arms (1)

FeNO

Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.

Device: NIOX MINO® Instrument (09-1100)

Interventions

NIOX MINO® Instrument (09-1100) DEVICE

FeNO

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects, 7 to 60 years of age, inclusive, with asthma will be recruited

You may qualify if:

• Age: 7 to 60 years of age, inclusive
• Sex: Males and Females
• Diagnosis: Asthma

You may not qualify if:

• Concurrent Conditions or Disease: Subjects with an established diagnosis of chronic, obstructive pulmonary disease (COPD) cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, or vocal cord dysfunction are excluded from participation
• Cigarette Smoking: Subjects with greater than a 10 pack-year history of cigarette smoking are excluded from participation
• Study Participation Outside of This Protocol: Subjects currently enrolled in studies of Investigational or Non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded from participation

Sponsors & Collaborators

• Aerocrine AB: lead

Study Sites (1)

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Related Publications (1)

• LaForce C, Brooks E, Herje N, Dorinsky P, Rickard K. Impact of exhaled nitric oxide measurements on treatment decisions in an asthma specialty clinic. Ann Allergy Asthma Immunol. 2014 Dec;113(6):619-23. doi: 10.1016/j.anai.2014.06.013. Epub 2014 Jul 22.

  PMID: 25060819 DERIVED

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

Results Point of Contact

• Title: Nancy Herje, BSN, RN, MBA
• Organization: Aerocrine, Inc.

Nancy.Herje@aerocrine.com

919-449-8873

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 20, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-01

Locations

US (1)