Observational Study of Obstructive Lung Disease (NOVELTY)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Asthma, COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Procedure: Blood draw
* Procedure: Urine
* Procedure: Lung function measurements
* Procedure: Fractional Exhaled Nitric Oxide (FENO)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic airways disease<br>Patients with suspected or primary diagnosis of asthma or COPD | Procedure: Blood draw<br>* Biomarkers analyses<br>Procedure: Urine<br>* Biomarker analyses<br>Procedure: Lung function measurements<br>* FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted<br>Procedure: Fractional Exhaled Nitric Oxide (FENO)<br>* Measures level of exhaled nitric oxide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L]) | Lung function test | Change from baseline FEV1 at Year 1, 2 and 3 | 
| Spirometry - change in Forced Vital Capacity (FVC) (L) | Lung function test | Change from baseline FVC at Year 1, 2 and 3 | 
| Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s]) | Lung function test | Change from baseline PEF at Year 1, 2 and 3 | 
| Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s) | Lung function test | Change from baseline FEF25-75% at Year 1, 2 and 3 | 
| Spirometry - change in Inspiratory Capacity (IC) (L) | Lung function test | Change from baseline IC at Year 1, 2 and 3 | 
| Post-bronchodilator spirometry - FEV1 (L) | Bronchodilator reversibility test | Baseline | 
| Post-bronchodilator spirometry - FVC (L) | Bronchodilator reversibility test | Baseline | 
| Post-bronchodilator spirometry - PEF (L/s) | Bronchodilator reversibility test | Baseline | 
| Post-bronchodilator spirometry - FEF25-75% (L/s) | Bronchodilator reversibility test | Baseline | 
| Post-bronchodilator spirometry - IC (L) | Bronchodilator reversibility test | Baseline | 
| Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb]) | Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath | Baseline | 
| Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT) | Patient reported outcome questionnaire | Change from baseline CAAT scores at Year 1, 2, and 3 | 
| Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale | Patient reported outcome questionnaire | Baseline | 
| Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ) | Patient reported outcome questionnaire | Change from baseline RSQ scores at Year 1, 2 and 3 | 
| Change in symptoms/symptom control assessed by the Asthma Control Test (ACT) | Patient reported outcome questionnaire | Change from baseline ACT scores at Year 1, 2 and 3 | 
| COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD | Patient reported outcome questionnaire | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, COPD, chronic obstructive pulmonary disease, lung disease, chronic airways disease, obstructive lung disease