Evaluation of FeNO During and Following Acute COPD Exacerbation

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01761006
• Other study ID #: IRB00021832
• Status: Terminated
• Phase: N/A
• First received: December 19, 2012
• Last updated: November 3, 2017
• Start date: March 2013
• Est. completion date: September 23, 2014

Study information

• Verified date: May 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 23, 2014
• Est. primary completion date: September 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NIOX MINO®

Locations

Country	Name	City	State
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Aerocrine AB

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rennard SI. COPD: overview of definitions, epidemiology, and factors influencing its development. Chest. 1998 Apr;113(4 Suppl):235S-241S. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.