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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760329
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : November 28, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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
Asthma COPD Chronic Obstructive Pulmonary Disease Procedure: Blood draw Procedure: Urine Procedure: Lung function measurements Procedure: Fractional Exhaled Nitric Oxide (FENO)

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Study Design
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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 : July 25, 2016
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 130 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760329


Locations
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Sponsors and Collaborators
AstraZeneca
Parexel
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02760329    
Other Study ID Numbers: D2287R00103
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: November 2022
Keywords provided by AstraZeneca:
asthma
COPD
chronic obstructive pulmonary disease
 lung disease
chronic airways disease
obstructive lung disease
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents