Observational Study of Obstructive Lung Disease (NOVELTY)
Condition: Asthma; COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

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.
    

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.
    

Intervention name(s): Blood draw; Urine; Lung function measurements; Fractional Exhaled Nitric Oxide (FENO)
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Biomarkers analyses; Biomarker analyses; FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted; Measures level of exhaled nitric oxide.
Intervention MeSH terms: Nitric Oxide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
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.
      
Biospecimen description: 
      Biomarkers from blood samples including assessment of haematology and collection for storage
      of serum, plasma, deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and urine samples.
      Collection of blood and urine samples is optional and will be covered in a separate section
      of the informed consent form.
    
Keywords: asthma; COPD; chronic obstructive pulmonary disease; lung disease; chronic airways disease; obstructive lung disease