Observational Study of Obstructive Lung Disease (NOVELTY) (NOVELTY)
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ClinicalTrials.gov Identifier: NCT02760329 |
Recruitment Status :
Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : November 28, 2022
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Condition or disease | Intervention/treatment |
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Asthma COPD Chronic Obstructive Pulmonary Disease | Procedure: Blood draw Procedure: Urine Procedure: Lung function measurements Procedure: Fractional Exhaled Nitric Oxide (FENO) |

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 |

Group/Cohort | Intervention/treatment |
---|---|
Chronic airways disease
Patients with suspected or primary diagnosis of asthma or COPD
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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. |
- 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
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
asthma COPD chronic obstructive pulmonary disease |
lung disease chronic airways disease obstructive lung disease |
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 |