A Single-Center Exploratory Study to Evaluate FeNO Using the NIOX MINO® Device in COPD Patients Aged ≥40 Years During and Following Recovery From an Acute COPD Exacerbation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Wake Forest University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in FeNO from Day 0 to the end of the study
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes up during an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD) and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation.
Detailed Description
The purpose of this research study is to determine whether exhaled nitric oxide (FeNO) goes up during an acute exacerbation of COPD and whether the level of exhaled nitric oxide returns to normal in the weeks after an exacerbation. FeNO is measured with a medical device called the NIOX MINO®. The NIOX MINO® device has been cleared by the Food and Drug Administration (FDA) for use in children and adults age 7 and older to measure Fractional Exhaled Nitric Oxide (FeNO) in human breath.This information will be useful for determining whether FeNO may help predict the development of a COPD exacerbation and/or be useful for identifying patients who will have a beneficial therapeutic response to inhaled or systemic corticosteroids during a COPD exacerbation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 40 years and above, inclusive
- •Sex: Males and Females
- •Smoking History: ≥20 pack years.
- •COPD Defined as an FEV1/ FVC or FEV1/SVC ratio \<70% predicted.
- •AECOPD defined as a clinically significant worsening of COPD symptoms requiring treatment with antibiotics and/or systemic steroids and/or hospitalization for same.
Exclusion Criteria
- •Use of Systemic Corticosteroids for more than 48 hours prior to Visit
- •AECOPD requiring mechanical ventilation
- •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.
Outcomes
Primary Outcomes
Change in FeNO from Day 0 to the end of the study
Time Frame: Time points for measurement of the Primary Endpoint will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.
Secondary Outcomes
- Change in Inspiratory Capacity from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in COPD Assessment Test (CAT) Responses from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in FEV1/FVC from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in FEV1 from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in FEF25-75 from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in PEF from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in Slow Vital Capacity (SVC) from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)
- Change in FEV1/SVC from Day 0 to the end of the study(Time points for measurement of the Secondary Endpoints will be between Day 0 (considered baseline) and Visit 2/Day 14, Visit 3/Day 28 and Visit 4/Day 56.)