Brief Summary
The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.
Brief Title
Observational Study of Obstructive Lung Disease (NOVELTY)
Detailed Description
The NOVELTY study is a multi-country, multicentre, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.
It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.
Exposure(s):
The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).
Sample Size Estimations:
The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.
Statistical Analysis:
After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.
Patients' changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.
To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.
Multivariable models will be used to assess the following: the occurrence of exacerbations and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO) and disease control with impact on daily activity and quality of life, and the relationship between healthcare resource use overall and related to respiratory diseases with disease severity, clinical outcomes, disease type, etc.
Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on biomarkers and/or clinical parameters that are associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.
It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.
Exposure(s):
The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).
Sample Size Estimations:
The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.
Statistical Analysis:
After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.
Patients' changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.
To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.
Multivariable models will be used to assess the following: the occurrence of exacerbations and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO) and disease control with impact on daily activity and quality of life, and the relationship between healthcare resource use overall and related to respiratory diseases with disease severity, clinical outcomes, disease type, etc.
Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on biomarkers and/or clinical parameters that are associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
COPD
Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
* Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
* Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
* Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
* Enrolment from an active clinical practice
Exclusion Criteria:
* Patients who participated in any respiratory interventional trial during the 12 months prior to enrolment or at enrolment
* Patients who, in the opinion of the physician, are unlikely to complete 3 years of follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity
* Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another respiratory disease such as bronchiectasis or interstitial lung disease together with asthma or COPD will be accepted)
In addition, the following are considered criteria for exclusion from the exploratory genetic research (donation of blood for DNA and RNA analysis)
* Previous allogeneic bone marrow transplant
* Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
* Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
* Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
* Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
* Enrolment from an active clinical practice
Exclusion Criteria:
* Patients who participated in any respiratory interventional trial during the 12 months prior to enrolment or at enrolment
* Patients who, in the opinion of the physician, are unlikely to complete 3 years of follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity
* Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another respiratory disease such as bronchiectasis or interstitial lung disease together with asthma or COPD will be accepted)
In addition, the following are considered criteria for exclusion from the exploratory genetic research (donation of blood for DNA and RNA analysis)
* Previous allogeneic bone marrow transplant
* Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Inclusion Criteria
Inclusion Criteria:
* Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
* Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
* Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
* Enrolment from an active clinical practice
* Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
* Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
* Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
* Enrolment from an active clinical practice
Gender
All
Gender Based
false
Keywords
asthma
COPD
chronic obstructive pulmonary disease
lung disease
chronic airways disease
obstructive lung disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
130 Years
Minimum Age
12 Years
NCT Id
NCT02760329
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D2287R00103
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A NOVEL Observational longiTudinal studY on Patients With Asthma and/or COPD to Describe Patient Characteristics, Treatment Patterns and the Burden of Illness Over Time and to Identify Phenotypes and Endotypes.
Primary Outcomes
Outcome Description
Lung function test
Outcome Measure
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
Outcome Time Frame
Change from baseline FEV1 at Year 1, 2 and 3
Outcome Description
Lung function test
Outcome Measure
Spirometry - change in Forced Vital Capacity (FVC) (L)
Outcome Time Frame
Change from baseline FVC at Year 1, 2 and 3
Outcome Description
Lung function test
Outcome Measure
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
Outcome Time Frame
Change from baseline PEF at Year 1, 2 and 3
Outcome Description
Lung function test
Outcome Measure
Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
Outcome Time Frame
Change from baseline FEF25-75% at Year 1, 2 and 3
Outcome Description
Lung function test
Outcome Measure
Spirometry - change in Inspiratory Capacity (IC) (L)
Outcome Time Frame
Change from baseline IC at Year 1, 2 and 3
Outcome Description
Bronchodilator reversibility test
Outcome Measure
Post-bronchodilator spirometry - FEV1 (L)
Outcome Time Frame
Baseline
Outcome Description
Bronchodilator reversibility test
Outcome Measure
Post-bronchodilator spirometry - FVC (L)
Outcome Time Frame
Baseline
Outcome Description
Bronchodilator reversibility test
Outcome Measure
Post-bronchodilator spirometry - PEF (L/s)
Outcome Time Frame
Baseline
Outcome Description
Bronchodilator reversibility test
Outcome Measure
Post-bronchodilator spirometry - FEF25-75% (L/s)
Outcome Time Frame
Baseline
Outcome Description
Bronchodilator reversibility test
Outcome Measure
Post-bronchodilator spirometry - IC (L)
Outcome Time Frame
Baseline
Outcome Description
Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
Outcome Measure
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
Outcome Time Frame
Baseline
Outcome Description
Patient reported outcome questionnaire
Outcome Measure
Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)
Outcome Time Frame
Change from baseline CAAT scores at Year 1, 2, and 3
Outcome Description
Patient reported outcome questionnaire
Outcome Measure
Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale
Outcome Time Frame
Baseline
Outcome Description
Patient reported outcome questionnaire
Outcome Measure
Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)
Outcome Time Frame
Change from baseline RSQ scores at Year 1, 2 and 3
Outcome Description
Patient reported outcome questionnaire
Outcome Measure
Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)
Outcome Time Frame
Change from baseline ACT scores at Year 1, 2 and 3
Outcome Description
Patient reported outcome questionnaire
Outcome Measure
COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD
Outcome Time Frame
Baseline
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients with suspected or primary diagnosis of asthma and with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
130
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509