A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB
ClinicalTrials.gov Identifier:
NCT01648920
First received: July 5, 2012
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: November 27, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Asthma
Intervention: Device: NIOX MINO® Instrument (09-1100)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
FeNO

Participants with suspected but undiagnosed asthma had 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. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests

NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate.


Participant Flow:   Overall Study
    FeNO  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
50 subjects appeared to be a representative sample to generate summary statistics to characterize the data collected.

Reporting Groups
  Description
FeNO

Participants with suspected but undiagnosed asthma had 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. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests

NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate.


Baseline Measures
    FeNO  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean ( Full Range )
  24.7  
  ( 7 to 61 )  
Gender  
[units: participants]
 
Female     23  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     50  



  Outcome Measures
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1.  Primary:   Methacholine Challenge (MCC) Results   [ Time Frame: approximately 1-hour ]

2.  Primary:   Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results   [ Time Frame: approximately 1-hour ]

3.  Primary:   FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb   [ Time Frame: approximately 1-hour ]

4.  Primary:   FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb   [ Time Frame: approximately 1-hour ]

5.  Primary:   FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb   [ Time Frame: approximately 1-hour ]

6.  Primary:   Asthma Diagnosis by MCC Results: Positive MCC Response   [ Time Frame: approximately 1-hour ]

7.  Primary:   Asthma Diagnosis by MCC Results: Negative MCC Response   [ Time Frame: approximately 1-hour ]

8.  Primary:   Asthma Diagnosis by FeNO: FeNO <25ppb   [ Time Frame: approximately 1-hour ]

9.  Primary:   Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb   [ Time Frame: approximately 1-hour ]

10.  Primary:   Asthma Diagnosis by FeNO: FeNO >50ppb   [ Time Frame: approximately 1-hour ]

11.  Primary:   Asthma Diagnosis by FeNO: Mean FeNO Value   [ Time Frame: approximately 1-hour ]

12.  Primary:   Sensitivity (%) for FeNO   [ Time Frame: approximately 1-hour ]

13.  Primary:   Specificity (%) for FeNO   [ Time Frame: approximately 1-hour ]

14.  Primary:   Positive Predictive Value (%) for FeNO   [ Time Frame: approximately 1-hour ]

15.  Primary:   Negative Predictive Value (%) for FeNO   [ Time Frame: approximately 1-hour ]

16.  Primary:   FeNO Values by ICS Use: FeNO <25ppb   [ Time Frame: approximately 1-hour ]

17.  Primary:   FeNO Values by ICS Use: FeNO >= 50ppb   [ Time Frame: approximately 1-hour ]

18.  Primary:   FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb   [ Time Frame: approximately 1-hour ]

19.  Primary:   FeNO Values by Smoking Status: FeNO <25ppb   [ Time Frame: approximately 1-hour ]

20.  Primary:   FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb   [ Time Frame: approximately 1-hour ]

21.  Primary:   FeNO Values by Smoking Status: FeNO >= 50ppb   [ Time Frame: approximately 1-hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nancy Herje, BSN, RN, MBA. Director, Clinical Development and Medical Affairs
Organization: Aerocrine, Inc.
phone: 919-449-8873
e-mail: nancy.herje@aerocrine.com


No publications provided


Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01648920     History of Changes
Other Study ID Numbers: AER-044
Study First Received: July 5, 2012
Results First Received: November 27, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board