Evaluation of FeNO During and Following Acute COPD Exacerbation
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ClinicalTrials.gov Identifier: NCT01761006 |
Recruitment Status :
Terminated
(Study was activated initially. However, the necessary resources were not available to complete the research.)
First Posted : January 4, 2013
Last Update Posted : November 7, 2017
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Condition or disease | Intervention/treatment |
---|---|
Chronic Obstructive Pulmonary Disease | Device: NIOX MINO® |
Study Type : | Observational |
Actual Enrollment : | 10 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | 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 |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | September 23, 2014 |
Actual Study Completion Date : | September 23, 2014 |
- 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. ]
- Change in FEV1/FVC from Day 0 to the end of the study [ Time Frame: 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 Frame: 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 Frame: 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 Frame: 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 Inspiratory Capacity from Day 0 to the end of the study [ Time Frame: 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
- Change in Slow Vital Capacity (SVC) from Day 0 to the end of the study [ Time Frame: 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 Frame: 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 Frame: 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
- Evaluation of FEV1/FVC, FEV1, FEF25-75, FEF50, PEF and Inspiratory Capacity By FeNO Level at Baseline [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761006
United States, North Carolina | |
Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Jill Ohar, MD | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT01761006 |
Other Study ID Numbers: |
IRB00021832 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | November 7, 2017 |
Last Verified: | May 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COPD Chronic Obstructive Pulmonary Disease Exhaled Nitric Oxide NIOX MINO Acute COPD exacerbation |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |