Evaluation of FeNO During and Following Acute COPD Exacerbation - Full Text View

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:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

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 (Adult, Senior)
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

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, see Learn About Clinical Studies.

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 University

Aerocrine AB

Investigators


Principal Investigator:	Jill Ohar, MD	Wake Forest School of Medicine

More Information

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.


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 Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016