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Completed

NCT Number: NCT02760329

Observational Study of Obstructive Lung Disease (NOVELTY)

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.

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Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Monte Grande, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw

Procedure

Biomarkers analyses

Urine

Procedure

Biomarker analyses

Lung function measurements

Procedure

FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted

Fractional Exhaled Nitric Oxide (FENO)

Procedure

Measures level of exhaled nitric oxide.

Primary outcomes

  1. Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])

    Time frame: Change from baseline FEV1 at Year 1, 2 and 3

    Lung function test

  2. Spirometry - change in Forced Vital Capacity (FVC) (L)

    Time frame: Change from baseline FVC at Year 1, 2 and 3

    Lung function test

  3. Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])

    Time frame: Change from baseline PEF at Year 1, 2 and 3

    Lung function test

  4. Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)

    Time frame: Change from baseline FEF25-75% at Year 1, 2 and 3

    Lung function test

  5. Spirometry - change in Inspiratory Capacity (IC) (L)

    Time frame: Change from baseline IC at Year 1, 2 and 3

    Lung function test

  6. Post-bronchodilator spirometry - FEV1 (L)

    Time frame: Baseline

    Bronchodilator reversibility test

  7. Post-bronchodilator spirometry - FVC (L)

    Time frame: Baseline

    Bronchodilator reversibility test

  8. Post-bronchodilator spirometry - PEF (L/s)

    Time frame: Baseline

    Bronchodilator reversibility test

  9. Post-bronchodilator spirometry - FEF25-75% (L/s)

    Time frame: Baseline

    Bronchodilator reversibility test

  10. Post-bronchodilator spirometry - IC (L)

    Time frame: Baseline

    Bronchodilator reversibility test

  11. Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])

    Time frame: Baseline

    Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath

  12. Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)

    Time frame: Change from baseline CAAT scores at Year 1, 2, and 3

    Patient reported outcome questionnaire

  13. Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale

    Time frame: Baseline

    Patient reported outcome questionnaire

  14. Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)

    Time frame: Change from baseline RSQ scores at Year 1, 2 and 3

    Patient reported outcome questionnaire

  15. Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)

    Time frame: Change from baseline ACT scores at Year 1, 2 and 3

    Patient reported outcome questionnaire

  16. COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD

    Time frame: Baseline

    Patient reported outcome questionnaire

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study 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.

Acronym: NOVELTY

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
May 3, 2016
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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