Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms

Completed

Conditions studied: Asthma

In brief

Overall Aim: To better understand the diagnostic process for prolonged respiratory events and determine the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology. Study Objectives: The specific objectives of this study are to: * Determine the frequency of ICS prescription for the treatment of non-specific lower respiratory symptoms. * Determine the frequency of asthma diagnosis as an etiology for the non-specific lower respiratory symptoms. * Explore the value of FeNO in identifying asthma as the etiology of the non-specific lower respiratory symptoms. Number of Subjects: It is anticipated that up to approximately 3,000 patients will be asked to complete the brief screening questionnaire that will be used to identify up to approximately 280 eligible patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6 week study enrollment period. Reference Product: NIOX MINO® Duration of the participants involvement in the investigation: Single Visit Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO® device according to "Instructions for NO measurements" which will be provided to each Investigative site prior to patient enrollment. 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 from the time of informed consent/assent and during the study period. Criteria for Evaluation: The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS will be explored by correlation, measures of concordance and logistic modeling.

Key facts

Study ID

NCT01518322

Run by

Aerocrine AB

People needed

235

Starts

2011-11-01

Expected to finish

2012-02-01

Last updated by the study team

2013-08-30

Who can join

Age: 7 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Symptoms: Must have non-specific lower respiratory symptoms, such as cough, wheeze, and/or shortness of breath
• Age: Seven (7) to 65 years, inclusive
• Sex: Males and Females
• Ability to successfully perform assessment of FeNO: Investigators should use their judgment to determine if study candidates will be able to successfully perform assessment of FeNO using the NIOX MINO®.

You may not qualify if…

• Diagnosis: No previous or current diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
• Medications: No use of inhaled or oral corticosteroids within 7 days prior to the visit.
• Study Participation Outside of This Protocol: Patients 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.

Where it is running

• Olmstead Medical Center Byron — Byron, Minnesota, United States
• Olmstead Medical Center Chatfield — Chatfield, Minnesota, United States
• Olmstead Medical Center Pine Island — Pine Island, Minnesota, United States
• Olmstead Medical Center Plainview — Plainview, Minnesota, United States
• Olmstead Medical Center Preston — Preston, Minnesota, United States
• Olmstead Medical Center Northwest — Rochester, Minnesota, United States
• Olmstead Medical Center - Allergy Department — Rochester, Minnesota, United States
• Olmstead Medical Center - Family Medicine Department — Rochester, Minnesota, United States
• Olmsted Medical Center - Internal Medicine Department — Rochester, Minnesota, United States
• Olmstead Medical Center St. Charles — Saint Charles, Minnesota, United States
• Olmstead Medical Center Spring Valley — Spring Valley, Minnesota, United States
• Olmstead Medical Center Stewartville — Stewartville, Minnesota, United States
• Olmstead Medical Center Wanamingo — Wanamingo, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.