Evaluation of FeNO During and Following Acute COPD Exacerbation

This study is currently recruiting participants.
Verified March 2013 by Wake Forest School of Medicine
Sponsor:
Collaborator:
Aerocrine AB
Information provided by (Responsible Party):
Jill Ohar MD, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01761006
First received: December 19, 2012
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: NIOX MINO®

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Secondary Endpoint: Change in the responses on the CAT


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    • 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


Estimated Enrollment: 35
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected based on the fact that they are currently experiencing an acute COPD exacerbation. The study will be conducted at a single-center COPD Clinic at Wake Forest University Baptist Medical Center, Winston-Salem NC, USA. It is anticipated that approximately 35 Patients age 40 years and above will participate in the study.

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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761006

Contacts
Contact: Jill Ohar, MD 336-716-4328 johar@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jill Ohar, MD    336-716-4328    johar@wakehealth.edu   
Sponsors and Collaborators
Wake Forest School of Medicine
Aerocrine AB
Investigators
Principal Investigator: Jill Ohar, MD Wake Forest School of Medicine
  More Information

Publications:

Responsible Party: Jill Ohar MD, Professor of Medicine, Wake Forest University
ClinicalTrials.gov Identifier: NCT01761006     History of Changes
Other Study ID Numbers: IRB00021832
Study First Received: December 19, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
COPD
Chronic Obstructive Pulmonary Disease
Exhaled Nitric Oxide
NIOX MINO
Acute COPD exacerbation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014