Observational Study of Obstructive Lung Disease (NOVELTY)

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02760329
Collaborator
Parexel (Industry)
12,257
303
82.2
40.5
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood draw
  • Procedure: Urine
  • Procedure: Lung function measurements
  • Procedure: Fractional Exhaled Nitric Oxide (FENO)

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 Design

Study Type:
Observational
Actual Enrollment :
12257 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
Jul 25, 2016
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Chronic airways disease

Patients with suspected or primary diagnosis of asthma or COPD

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.

Outcome Measures

Primary Outcome Measures

  1. Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L]) [Change from baseline FEV1 at Year 1, 2 and 3]

    Lung function test

  2. Spirometry - change in Forced Vital Capacity (FVC) (L) [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]) [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) [Change from baseline FEF25-75% at Year 1, 2 and 3]

    Lung function test

  5. Spirometry - change in Inspiratory Capacity (IC) (L) [Change from baseline IC at Year 1, 2 and 3]

    Lung function test

  6. Post-bronchodilator spirometry - FEV1 (L) [Baseline]

    Bronchodilator reversibility test

  7. Post-bronchodilator spirometry - FVC (L) [Baseline]

    Bronchodilator reversibility test

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

    Bronchodilator reversibility test

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

    Bronchodilator reversibility test

  10. Post-bronchodilator spirometry - IC (L) [Baseline]

    Bronchodilator reversibility test

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

    Patient reported outcome questionnaire

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

    Patient reported outcome questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Loma Linda California United States 92357
2 Research Site Long Beach California United States 90822
3 Research Site Roseville California United States 95819-3957
4 Research Site Aurora Colorado United States 80045
5 Research Site Colorado Springs Colorado United States 80907
6 Research Site Clearwater Florida United States 33765
7 Research Site Gainesville Florida United States 32608-1197
8 Research Site Miami Florida United States 33032
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11 Research Site Chicago Illinois United States 60612
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13 Research Site Hutchinson Kansas United States 67502
14 Research Site Shreveport Louisiana United States 71106
15 Research Site Fall River Massachusetts United States 2720
16 Research Site Ann Arbor Michigan United States 48106
17 Research Site Buckley Michigan United States 49620
18 Research Site Hamtramck Michigan United States 48212
19 Research Site Lincoln Nebraska United States 68505
20 Research Site Atco New Jersey United States 8004
21 Research Site Highland Park New Jersey United States 8904
22 Research Site Albuquerque New Mexico United States 87109
23 Research Site Bronx New York United States 10459
24 Research Site Bronx New York United States 10461
25 Research Site Bronx New York United States 10465
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28 Research Site Rockville Centre New York United States 11570
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300 Research Site Watford United Kingdom
301 Research Site Wigginton United Kingdom
302 Research Site Wishaw United Kingdom
303 Research Site York United Kingdom

Sponsors and Collaborators

  • AstraZeneca
  • Parexel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02760329
Other Study ID Numbers:
  • D2287R00103
First Posted:
May 3, 2016
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 9, 2022