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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
Sponsor:
Collaborator:
Aerocrine AB
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date December 19, 2012
First Posted Date January 4, 2013
Last Update Posted Date November 7, 2017
Study Start Date March 2013
Actual Primary Completion Date September 23, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2013)
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. ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01761006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 4, 2013)
  • 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
Original Secondary Outcome Measures
 (submitted: January 2, 2013)
  • 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 FEF50 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 50% point (FEF 50)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Evaluation of FeNO During and Following Acute COPD Exacerbation
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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Obstructive Pulmonary Disease
Intervention Device: NIOX MINO®
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 2, 2017)
10
Original Estimated Enrollment
 (submitted: January 2, 2013)
35
Actual Study Completion Date September 23, 2014
Actual Primary Completion Date September 23, 2014   (Final data collection date for primary outcome measure)
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 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761006
Other Study ID Numbers IRB00021832
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor Wake Forest University
Collaborators Aerocrine AB
Investigators
Principal Investigator: Jill Ohar, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date May 2017