Evaluation of FeNO During and Following Acute COPD Exacerbation

• ClinicalTrials.gov Identifier: NCT01761006
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Last Update Posted: November 7, 2017
• Sponsor: Wake Forest University
• 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

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 *

• American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30.
• Barnes PJ, Dweik RA, Gelb AF, Gibson PG, George SC, Grasemann H, Pavord ID, Ratjen F, Silkoff PE, Taylor DR, Zamel N. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010 Sep;138(3):682-92. doi: 10.1378/chest.09-2090. Review.
• Centers for Disease Control and Prevention (CDC). Deaths from chronic obstructive pulmonary disease--United States, 2000-2005. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1229-32.
• Dweik RA, Boggs PB, Erzurum SC, Irvin CG, Leigh MW, Lundberg JO, Olin AC, Plummer AL, Taylor DR; American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011 Sep 1;184(5):602-15. doi: 10.1164/rccm.9120-11ST.
• Miller JD, Foster T, Boulanger L, Chace M, Russell MW, Marton JP, Menzin J. Direct costs of COPD in the U.S.: an analysis of Medical Expenditure Panel Survey (MEPS) data. COPD. 2005 Sep;2(3):311-8.
• Rennard SI. COPD: overview of definitions, epidemiology, and factors influencing its development. Chest. 1998 Apr;113(4 Suppl):235S-241S. Review.
• Siva R, Green RH, Brightling CE, Shelley M, Hargadon B, McKenna S, Monteiro W, Berry M, Parker D, Wardlaw AJ, Pavord ID. Eosinophilic airway inflammation and exacerbations of COPD: a randomised controlled trial. Eur Respir J. 2007 May;29(5):906-13. Epub 2007 Feb 14.
• van den Toorn LM, Overbeek SE, de Jongste JC, Leman K, Hoogsteden HC, Prins JB. Airway inflammation is present during clinical remission of atopic asthma. Am J Respir Crit Care Med. 2001 Dec 1;164(11):2107-13. Erratum in: Am J Respir Crit Care Med. 2002 Oct 15;166(8):1143.

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

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