NCT01761006

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2014

Completed
Last Updated

November 7, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

December 19, 2012

Last Update Submit

November 3, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDChronic Obstructive Pulmonary DiseaseExhaled Nitric OxideNIOX MINOAcute COPD exacerbation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in FEV1/FVC from Day 0 to the end of the study

    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

    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

    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

    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

    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.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Evaluation of FEV1/FVC, FEV1, FEF25-75, FEF50, PEF and Inspiratory Capacity By FeNO Level at Baseline

    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.

Interventions

NIOX MINO®DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related 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. doi: 10.1164/rccm.200406-710ST. No abstract available.

    PMID: 15817806BACKGROUND

  • 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.

    PMID: 20822990BACKGROUND

  • 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.

    PMID: 19008792BACKGROUND

  • 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.

    PMID: 21885636BACKGROUND

  • 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.

    PMID: 17146996BACKGROUND

  • 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.

    PMID: 9552012BACKGROUND

  • 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.

    PMID: 17301099BACKGROUND

  • 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.

    PMID: 11739143BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jill Ohar, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

January 4, 2013

Study Start

March 1, 2013

Primary Completion

September 23, 2014

Study Completion

September 23, 2014

Last Updated

November 7, 2017

Record last verified: 2017-05

Locations

US(1)