Chronic Obstructive Pulmonary Disease (COPD)NCT01634620
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Aerocrine AB at 2 sites in United States.
Trial summary
Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease Number of participants: Approximately 200 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fractional Exhaled… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- NIOX MINO® Instrument (09-1100)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Oct 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the UNC Hospital Outpatient Pulmonary Function Laboratory in Chapel Hill, NC and approximately 3 to 6 outpatient clinics associated with UNC who meet the inclusion/exclusion criteria
Who may be able to join
- Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD.
Who cannot join
- Concurrent Conditions or Disease: Subjects with other chronic obstructive lung diseases including but not limited to cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, vocal cord dysfunction, rhinosinusitis, non-eosinophilic asthma, and reactive airways dysfunction syndrome are excluded. In addition, subjects with pneumothorax, fractured rib(s), or signs of cardiac instability including but not limited to a recent myocardial infarction, unstable angina, unstable vital signs, or acute shortness of breath, chest tightness or chest pain are excluded.
- Study Participation Outside of This Protocol: Subjects 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
University of North Carolina Hospitals - Sanford Specialty Clinics
Sanford, North Carolina, 27330
About this study
Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease
Number of participants: Approximately 200 subjects will be enrolled
Read more
Reference product: NIOX MINO® Instrument (09-1100)
Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual
Safety assessments: The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time that informed consent has been provided and during the study period
Criteria for evaluations: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design subsequent studies in patients with chronic obstructive airways disease. Information collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing
Read the detailed description
INTRODUCTION
Overview:
The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical practice at the point-of-care. Airway inflammation is now recognized as the central mechanism in the pathogenesis of asthma and its symptoms. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway diseases such as asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Burden of Disease:
Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of diseases characterized by chronic airflow obstruction that interferes with normal breathing . The Centers for Disease Control and Prevention (CDC) reported that in the year 2005, approximately one in 20 deaths in the United States had COPD as the underlying cause.
Role of Exhaled Nitric Oxide (FeNO):
FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part of the inflammatory process.
COPD can coexist with asthma. However, the exact role of FeNO in patients with established COPD remains to be the defined. While COPD airway inflammation is usually associated with increased neutrophils, some patients with COPD may have features of asthma such as a mixed inflammatory pattern with increased eosinophils. However, many patients have difficulty expectorating sputum and/or can only produce poor quality sputum samples which are not adequate to accurately quantify eosinophilic cells. Since FeNO can be measured easily and reliably, it may be useful in evaluating airway inflammation in COPD and thus predicting steroid responsiveness in COPD.
Intended Use:
NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and according to guidelines for NO measurement established by the American Thoracic Society.
Rationale for Study:
While there have been a number of preliminary studies on FeNO in COPD, literature defining the role of FeNO in patients with established COPD is minimal. The purpose of the current study, therefore is to characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease. This data may be useful in determining whether or not FeNO can predict improvement in FEV1 following ICS treatment
CLINICAL INVESTIGATION OBJECTIVES To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease.
CLINICAL INVESTIGATION PLAN
This is a pilot, observational, multi-center, single-visit, outpatient study. Subjects meeting all of the Inclusion Criteria and none of the Exclusion Criteria, and who express interest in study participation, will be asked to provide the following documentation and information:
- Informed Consent
- Demographics
- Baseline Characteristics
- FeNO:
- Subjects will receive training by the study staff on use of the NIOX MINO® device to perform FeNO Measurements
- Spirometry
- Severity of COPD
Subject discharge from the study:
Once all information has been collected and all procedures have been performed, the subject will be discharged from the clinic and their study participation will be complete
Selection of investigation population:
Male and female subjects, age 40 years and above, inclusive, with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema and/or a mixed diagnosis of asthma/COPD will be recruited. A subject should be withdrawn from the clinical investigation if, in the opinion of the Investigator, it is medically necessary, or if it is the expressed wish of the subject.
Medical device:
The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation. The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in adults 18 years of age or older in the initial assessment and management of asthma.
The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate. Results are provided at the point of care within 2 minutes after the successful completion of the breath test. The test cannot be influenced by patient effort or variations in the clinician's test technique.
Definitions:
Adverse event: Any incident where the use of a medical device (including in vitro diagnostics) is suspected to have resulted in an adverse outcome in a patient.
Serious Injury means injury or illness that:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure, or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Malfunction: the failure of a device to meet its performance specifications or otherwise perform as intended.
Caused or contributed: the death or serous injury was or may have been attributed to a medical device, or that the medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
- Failure
- Malfunction
- Improper or inadequate design
- Manufacture
- Labeling
- User error
- Being tested
- NIOX MINO® Instrument (09-1100)
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Airways Disease, Chronic Bronchitis, Chronic Emphysema, Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIOX MINO® Instrument (09-1100)Device
FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)
| Study group | Role | What they receive |
|---|---|---|
| FeNO | Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Receives: Device: NIOX MINO® Instrument (09-1100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry Results: FEV1 (L)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
Spirometry Results: FVC (L)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
Spirometry Results: FEV1 (% Predicted)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
Spirometry Results: FEF50% (L/Sec)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
Spirometry Results: FEF25-75 (L/Sec)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
Spirometry Results: PEF (L/Min)
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Measured: Single Visit
FeNO Levels by GOLD Stage of Severity
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.
Measured: Single Visit
FeNO Levels by Inhaled Corticosteroid Use
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.
Measured: Single Visit
FeNO Levels by Smoking Status
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.
Measured: Single Visit
FeNO Levels by ICD 9 Code Category
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
Measured: Single Visit
Mean FeNO Levels by ICD 9 Code Category
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
Measured: Single Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerocrine AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Donohue, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634620
- Sponsor's protocol ID
- AER-042
- Status last verified
- Jan 2014
- First submitted
- 3 Jul 2012
- Last updated
- 12 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
- ClinicalTrials.gov ID
- NCT01634620
- Acronym / sponsor ID
- AER-042
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Airways Disease, Chronic Bronchitis, Chronic Emphysema, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aerocrine ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Posted 12 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease
Number of participants: Approximately 200 subjects will be enrolled
Reference product: NIOX MINO® Instrument (09-1100)
Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual
Safety assessments: The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time that informed consent has been provided and during the study period
Criteria for evaluations: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design subsequent studies in patients with chronic obstructive airways disease. Information collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing
Detailed description
INTRODUCTION
Overview:
The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical practice at the point-of-care. Airway inflammation is now recognized as the central mechanism in the pathogenesis of asthma and its symptoms. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway diseases such as asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Burden of Disease:
Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of diseases characterized by chronic airflow obstruction that interferes with normal breathing . The Centers for Disease Control and Prevention (CDC) reported that in the year 2005, approximately one in 20 deaths in the United States had COPD as the underlying cause.
Role of Exhaled Nitric Oxide (FeNO):
FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part of the inflammatory process.
COPD can coexist with asthma. However, the exact role of FeNO in patients with established COPD remains to be the defined. While COPD airway inflammation is usually associated with increased neutrophils, some patients with COPD may have features of asthma such as a mixed inflammatory pattern with increased eosinophils. However, many patients have difficulty expectorating sputum and/or can only produce poor quality sputum samples which are not adequate to accurately quantify eosinophilic cells. Since FeNO can be measured easily and reliably, it may be useful in evaluating airway inflammation in COPD and thus predicting steroid responsiveness in COPD.
Intended Use:
NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and according to guidelines for NO measurement established by the American Thoracic Society.
Rationale for Study:
While there have been a number of preliminary studies on FeNO in COPD, literature defining the role of FeNO in patients with established COPD is minimal. The purpose of the current study, therefore is to characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease. This data may be useful in determining whether or not FeNO can predict improvement in FEV1 following ICS treatment
CLINICAL INVESTIGATION OBJECTIVES To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease.
CLINICAL INVESTIGATION PLAN
This is a pilot, observational, multi-center, single-visit, outpatient study. Subjects meeting all of the Inclusion Criteria and none of the Exclusion Criteria, and who express interest in study participation, will be asked to provide the following documentation and information:
- Informed Consent
- Demographics
- Baseline Characteristics
- FeNO:
- Subjects will receive training by the study staff on use of the NIOX MINO® device to perform FeNO Measurements
- Spirometry
- Severity of COPD
Subject discharge from the study:
Once all information has been collected and all procedures have been performed, the subject will be discharged from the clinic and their study participation will be complete
Selection of investigation population:
Male and female subjects, age 40 years and above, inclusive, with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema and/or a mixed diagnosis of asthma/COPD will be recruited. A subject should be withdrawn from the clinical investigation if, in the opinion of the Investigator, it is medically necessary, or if it is the expressed wish of the subject.
Medical device:
The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation. The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in adults 18 years of age or older in the initial assessment and management of asthma.
The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate. Results are provided at the point of care within 2 minutes after the successful completion of the breath test. The test cannot be influenced by patient effort or variations in the clinician's test technique.
Definitions:
Adverse event: Any incident where the use of a medical device (including in vitro diagnostics) is suspected to have resulted in an adverse outcome in a patient.
Serious Injury means injury or illness that:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure, or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Malfunction: the failure of a device to meet its performance specifications or otherwise perform as intended.
Caused or contributed: the death or serous injury was or may have been attributed to a medical device, or that the medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
- Failure
- Malfunction
- Improper or inadequate design
- Manufacture
- Labeling
- User error
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FeNO | – | Device: NIOX MINO® Instrument (09-1100)Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the UNC Hospital Outpatient Pulmonary Function Laboratory in Chapel Hill, NC and approximately 3 to 6 outpatient clinics associated with UNC who meet the inclusion/exclusion criteria
Key inclusion criteria (1 listed)
- Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD.
Key exclusion criteria (2 listed)
- Concurrent Conditions or Disease: Subjects with other chronic obstructive lung diseases including but not limited to cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, vocal cord dysfunction, rhinosinusitis, non-eosinophilic asthma, and reactive airways dysfunction syndrome are excluded. In addition, subjects with pneumothorax, fractured rib(s), or signs of cardiac instability including but not limited to a recent myocardial infarction, unstable angina, unstable vital signs, or acute shortness of breath, chest tightness or chest pain are excluded.
- Study Participation Outside of This Protocol: Subjects 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIOX MINO® Instrument (09-1100)FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) | Device | FeNO |
Primary outcome
Spirometry Results: FEV1 (L)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Spirometry Results: FVC (L)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Spirometry Results: FEV1 (% Predicted)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Spirometry Results: FEF50% (L/Sec)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Spirometry Results: FEF25-75 (L/Sec)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
Spirometry Results: PEF (L/Min)
Time frame: Single Visit
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
FeNO Levels by GOLD Stage of Severity
Time frame: Single Visit
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.
FeNO Levels by Inhaled Corticosteroid Use
Time frame: Single Visit
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.
FeNO Levels by Smoking Status
Time frame: Single Visit
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.
FeNO Levels by ICD 9 Code Category
Time frame: Single Visit
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
Mean FeNO Levels by ICD 9 Code Category
Time frame: Single Visit
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Donohue, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Aerocrine AB at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry Results: FEV1 (L) (time frame: Single Visit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.