Evaluation of FeNO During and Following Acute COPD Exacerbation

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: NIOX MINO®

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
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1/FVC from Day 0 to the end of the study	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)	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.
Change in FEV1 from Day 0 to the end of the study	Secondary Endpoint: Change in Forced Expiratory Volume at one second (FEV1)	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.
Change in FEF25-75 from Day 0 to the end of the study	Secondary Endpoint: Change in Forced Expiratory Flow at the 25% point to the 75% point (FEF25-75)	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.
Change in PEF from Day 0 to the end of the study	Secondary Endpoint: Change in Peak Expiratory Flow (PEF)	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.
Change in Inspiratory Capacity from Day 0 to the end of the study	Secondary Endpoint: Change in Inspiratory Capacity	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.
Change in Slow Vital Capacity (SVC) from Day 0 to the end of the study	Secondary Endpoint: Change in Slow Vital Capacity	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.
Change in FEV1/SVC from Day 0 to the end of the study	Secondary Endpoint: Change in the ratio of FEV1 to Slow Vital Capacity	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.
Change in COPD Assessment Test (CAT) Responses from Day 0 to the end of the study	Secondary Endpoint: Change in the responses on the CAT	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of FEV1/FVC, FEV1, FEF25-75, FEF50, PEF and Inspiratory Capacity By FeNO Level at Baseline	• 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	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.

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Aerocrine AB
• Investigators: Principal Investigator: Jill Ohar, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Rennard SI. COPD: overview of definitions, epidemiology, and factors influencing its development. Chest. 1998 Apr;113(4 Suppl):235S-241S. doi: 10.1378/chest.113.4_supplement.235s.
• 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. doi: 10.1164/rccm.200406-710ST. No abstract available.
• 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.
• 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. doi: 10.1080/15412550500218221.
• 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. doi: 10.1183/09031936.00146306. 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. doi: 10.1164/ajrccm.164.11.2006165. Erratum In: Am J Respir Crit Care Med. 2002 Oct 15;166(8):1143.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 23, 2014
• Study Completion (Actual): September 23, 2014

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: January 2, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Exhaled Nitric Oxide; NIOX MINO; Acute COPD exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IRB00021832

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No