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Observational Study of Obstructive Lung Disease (NOVELTY) (NOVELTY)

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ClinicalTrials.gov Identifier: NCT02760329
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date April 5, 2016
First Posted Date May 3, 2016
Last Update Posted Date May 17, 2019
Actual Study Start Date July 25, 2016
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2016)
  • 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
  • Spirometry - change in Forced Vital Capacity (FVC) (L) [ Time Frame: Change from baseline FVC at Year 1, 2 and 3 ]
    Lung function test
  • 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
  • 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
  • Spirometry - change in Inspiratory Capacity (IC) (L) [ Time Frame: Change from baseline IC at Year 1, 2 and 3 ]
    Lung function test
  • Post-bronchodilator spirometry - FEV1 (L) [ Time Frame: Baseline ]
    Bronchodilator reversibility test
  • Post-bronchodilator spirometry - FVC (L) [ Time Frame: Baseline ]
    Bronchodilator reversibility test
  • Post-bronchodilator spirometry - PEF (L/s) [ Time Frame: Baseline ]
    Bronchodilator reversibility test
  • Post-bronchodilator spirometry - FEF25-75% (L/s) [ Time Frame: Baseline ]
    Bronchodilator reversibility test
  • Post-bronchodilator spirometry - IC (L) [ Time Frame: Baseline ]
    Bronchodilator reversibility test
  • Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb]) [ Time Frame: Baseline ]
    Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
  • 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
  • Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale [ Time Frame: Baseline ]
    Patient reported outcome questionnaire
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02760329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Obstructive Lung Disease (NOVELTY)
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.
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
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.
Condition
  • Asthma
  • COPD
  • Chronic Obstructive Pulmonary Disease
Intervention
  • Procedure: Blood draw
    Biomarkers analyses
  • Procedure: Urine
    Biomarker analyses
  • Procedure: Lung function measurements
    FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
  • Procedure: Fractional Exhaled Nitric Oxide (FENO)
    Measures level of exhaled nitric oxide.
Study Groups/Cohorts Chronic airways disease
Patients with suspected or primary diagnosis of asthma or COPD
Interventions:
  • Procedure: Blood draw
  • Procedure: Urine
  • Procedure: Lung function measurements
  • Procedure: Fractional Exhaled Nitric Oxide (FENO)
Publications * Reddel HK, Gerhardsson de Verdier M, Agustí A, Anderson G, Beasley R, Bel EH, Janson C, Make B, Martin RJ, Pavord I, Price D, Keen C, Gardev A, Rennard S, Sveréus A, Bansal AT, Brannman L, Karlsson N, Nuevo J, Nyberg F, Young SS, Vestbo J. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Res. 2019 Feb 1;5(1). pii: 00036-2018. doi: 10.1183/23120541.00036-2018. eCollection 2019 Feb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
11182
Original Estimated Enrollment
 (submitted: April 30, 2016)
14800
Estimated Study Completion Date May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Argentina,   Australia,   Brazil,   Canada,   China,   Colombia,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02760329
Other Study ID Numbers D2287R00103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Parexel
Investigators
Study Director: Maria Gerhardsson de Verdier AstraZeneca
Study Chair: Helen Reddel University of Sydney
Study Chair: Jorgen Vestbo University of Manchester
PRS Account AstraZeneca
Verification Date May 2019