Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a real-life setting: the NOVEL observational longiTudinal studY

Author:

Papi Alberto1ORCID,Hughes Rod2,del Olmo Ricardo3,Agusti Alvar4,Chipps Bradley E.5,Make Barry6,Tomaszewski Erin7,Peres Da Costa Keith8,Srivastava Divyansh9,Vestbo Jørgen10,Janson Christer11,Burgel Pierre-Régis1213,Price David1415ORCID

Affiliation:

1. Respiratory Unit, Emergency Department, Research Centre on Asthma and COPD, University of Ferrara, University Hospital S. Anna, Ferrara 44124, Italy

2. Research and Early Development, Respiratory and Immunology, AstraZeneca, Cambridge, UK

3. Diagnostic and Treatment Department, Hospital de Rehabilitación Respiratoria ‘Maria Ferrer’ and IDIM CR, Buenos Aires, Argentina

4. Respiratory Institute, Hospital Clinic, Cátedra de Salud Respiratoria, University of Barcelona, IDIBAPS, and CIBERES, Barcelona, Spain

5. Capital Allergy & Respiratory Disease Center, Sacramento, CA, USA

6. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health and University of Colorado Denver, Denver, CO, USA

7. BioPharmaceuticals Medical, Patient-Centered Science, AstraZeneca, Gaithersburg, MD, USA

8. R&D Data Science, Real World Evidence, ZS Associates, London, UK

9. Real World Evidence, ZS Associates, Pune, India

10. Division of Immunology, Immunity to Infection and Respiratory Medicine, School of Biological Sciences, University of Manchester, Manchester, UK

11. Department of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden

12. Service de Pneumologie, Hôpital Cochin, Assistance Publique Hôpitaux de Paris

13. Institut Cochin, Inserm U1016, Université Paris Cité, Paris, France

14. Observational and Pragmatic Research Institute, Singapore, Singapore

15. Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK

Abstract

Background: The relationships between spirometric assessment of lung function and symptoms (including exacerbations) in patients with asthma and/or chronic obstructive pulmonary disease (COPD) in a real-life setting are uncertain. Objectives: To assess the relationships between baseline post-bronchodilator (post-BD) spirometry measures of lung function and symptoms and exacerbations in patients with a physician-assigned diagnosis of asthma and/or COPD. Design: The NOVEL observational longiTudinal studY (NOVELTY) is a global, prospective, 3-year observational study. Methods: Logistic regression analysis was used to evaluate relationships. Spirometry measures were assessed as percent predicted (%pred). Symptoms were assessed at baseline, and exacerbations were assessed at baseline and Year 1. Results: A total of 11,181 patients in NOVELTY had spirometry data (asthma, n = 5903; COPD, n = 3881; asthma + COPD, n = 1397). A 10% lower post-BD %pred forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) – adjusted for age and sex – were significantly associated with dyspnea (modified Medical Research Council ⩾ grade 2), frequent breathlessness [St George’s Respiratory Questionnaire (SGRQ)], frequent wheeze attacks (SGRQ), nocturnal awakening (Respiratory Symptoms Questionnaire; ⩾1 night/week), and frequent productive cough (SGRQ). Lower post-BD %pred FEV1 and, to a lesser extent, lower post-BD %pred FVC were significantly associated with ⩾1 physician-reported exacerbation at baseline or Year 1. This association was stronger in patients with COPD than in those with asthma. Conclusion: In a real-life setting, reduced lung function is consistently associated with symptoms in patients with asthma, COPD, or asthma + COPD. The relationship with exacerbations is stronger in COPD only than in asthma. Trail registration: clinicaltrials.gov identifier: NCT02760329 ( www.clinicaltrials.gov ).

Funder

AstraZeneca

Publisher

SAGE Publications

Reference26 articles.

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