Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Exhaled Nitric Oxide, NIOX MINO, Acute COPD exacerbation
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.
Interventions
DEVICENIOX MINO®
Sponsors
Aerocrine AB
Wake Forest University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FeNO from Day 0 to the end of the study | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Secondary Endpoint: Change in proportion of a person's vital capacity that they are able to expire in the first second of expiration (FEV1/FVC) |
| 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. | Secondary Endpoint: Change in Forced Expiratory Volume at one second (FEV1) |
| 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. | Secondary Endpoint: Change in Forced Expiratory Flow at the 25% point to the 75% point (FEF25-75) |
| 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. | Secondary Endpoint: Change in Peak Expiratory Flow (PEF) |
| 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. | Secondary Endpoint: Change in Slow Vital Capacity |
| 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. | Secondary Endpoint: Change in the ratio of FEV1 to Slow Vital Capacity |
| 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. | Secondary Endpoint: Change in the responses on the CAT |
| 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. | Secondary Endpoint: Change in Inspiratory Capacity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of FEV1/FVC, FEV1, FEF25-75, FEF50, PEF and Inspiratory Capacity By FeNO Level at Baseline | 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. | • Other endpoint - the secondary endpoints will be evaluated by FeNO level at baseline as follows: * FeNO ≤ 25 ppb versus FeNO \> 25 ppb * FeNO \<50 ppb versus FeNO ≥ 50 ppb * FeNO \> 25 ppb and FeNO \< 50 ppb versus FeNO\<25 and versus FeNO ≥ 50 ppb |
Countries
United States
Outcome results
None listed