Clinical Evolution and Quality of Life in Clinically Based COPD Chronic Bronchitic and Emphysematous Phenotypes: Results from the 1-Year Follow-Up of the STORICO Italian Observational Study

Abstract

Introduction

Understanding clinical evolution of chronic obstructive pulmonary disease (COPD) is crucial for improving disease management.

Materials and Methods

STORICO (NCT03105999), an Italian, multicenter, non-interventional, observational study conducted in 40 pulmonology centers, aimed to describe the 1-year clinical evolution and health status of clinicallbased phenotypes. Baseline and follow-up data of COPD subjects with a chronic bronchitis (CB) or emphysema (EM) phenotype were collected. The frequency of COPD symptoms during the 24 hours (gathered via the night-time, morning and day-time symptoms of COPD questionnaire) and the anxiety and depression levels (via the HADS Scale) were recorded at each visit.

Results

A total of 261 CB and 159 EM patients were analyzed. CB patients with ≥1 night-time symptom seemed to be more frequent (51.7%, 41.8% and 41.4% at baseline, 6-month and 12-month follow-up, respectively) than EM (37.7%, 32.1% and 30.2% at study visits) even if no statistical differences were observed at time points between phenotypes (chi-square test p-values presence/absence of night-time symptoms in CB vs EM at study visits >0.0007). In the first 6 months, the frequency of patients with ≥1 night-time symptom decreased of 9.9% in CB and of 5.6% in EM. A clinically relevant decline of DLCO % predicted over 1 year in EM was observed, the mean (SD) being 61.5 (20.8) % at baseline and 59.1 (17.4) % at 12-month follow-up. EM had higher levels of anxiety and depression than CB (median (25th-75th percentile) HADS total score in CB: 7.0 (4.0–13.0) and 7.0 (3.0–12.0), in EM: 9.0 (3.0–14.0) and 9.5 (3.0–14.0) both at baseline and at 6-month follow-up, respectively), considering 1.17 as minimally clinical important difference (MCID) for the total score.

Conclusion

EM patients, evaluated in a real-world setting, seem to suffer from a worse clinical condition and health status compared to CB patients, appearing to have “more treatable” traits.

Keywords:

• COPD
• clinical phenotype
• clinical evolution
• quality of life

Abbreviations

ATS, American Thoracic Society; BMI, body mass index; CASIS, COPD and Asthma Sleep Impact Scale; CAT, COPD Assessment Test; CB, chronic bronchitis; COPD, chronic obstructive pulmonary disease; DLCO, diffusion capacity for carbon monoxide; eGFR, estimated glomerular filtration rate; EM, emphysema; ERS, European Respiratory Society; FEV1, forced expiratory volume in the first second; FVC, forced vital capacity; GERD, gastroesophageal reflux disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HADS, Hospital Anxiety and Depression Scale; ICS, inhaled corticosteroids; IPAQ, International Physical Activity Questionnaire; IQR, interquartile range; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonists; MCA, mixed COPD-asthma; mMRC, modified Medical Research Council; NK, unknown; PROs, patient reported outcomes; RV, residual volume; SD, standard deviation; SGRQ, St. George’s Respiratory Questionnaire; TLC, total lung capacity.

Data Sharing Statement

The data that support the findings of this study are available from authors and Laboratori Guidotti, Italy but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. There are legal and ethical restrictions since data contain potentially sensitive patient information. Data are, however, available from the authors and Laboratori Guidotti upon reasonable request. Data request may be sent to the first author ([email protected]) and to Stefania Barsanti (Laboratori Guidotti, [email protected]).

Ethics Approval and Consent to Participate

The study was approved by the Ethics Committee of the coordinating center (Fondazione Toscana G. Monasterio Pisa, Italy) and was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practices guidelines for observational studies, complying with all requirements of local regulations. Patients provided written informed consent before study participation.

Acknowledgments

We are grateful to Sara Rizzoli for her help in drafting the manuscript. We are also grateful to the participating centers, involved in data collection and to Giovannetti Clara, Barsanti Stefania, Briguglio Chiara, for their contribution in the interpretation of the work and in critical revision of the article.

Members of the STORICO Study Group – Participating Centers

Pietro Schino (Acquaviva delle Fonti); Giuseppina Cuttitta (Palermo); Maria Pia Foschino (Foggia); Renato Prediletto (Pisa); Carmelindo Mario Enrico Tranfa (Napoli); Maria Cristina Zappa (Roma); Pasquale Patriciello (Pollena Trocchia); Luciana Labate (Bari); Salvatore Mariotta (Roma); Stefano Nava (Bologna); Alessandro Vatrella (Salerno); Michele Mastroberardino (Avellino); Riccardo Sarzani (Ancona); Antonio Iuliano (Milano); Lamberto Maggi (Bergamo); Anna Zedda (Casoria); Alberto Pesci (Monza); Giuseppe Sera (Torino); Antonello Nicolini (Sestri Levante); Salvatore Walter Di Donato (Mondragone); Silvia Forte (Roma); Mario Del Donno (Benevento); Federica Rivolta (Abbiategrasso); Mauro Ferliga (Chiari); Antonio Filippo Raco (Menaggio); Luigi Di Re (Teramo); Gaetano Cabibbo (Modica); Rosario Maselli (Catanzaro); Carlo Gulotta (Orbassano); Stefano Nardini (Vittorio Veneto); Enrico Eugenio Guffanti (Casatenovo); Walter Castellani (Firenze); Luca Triolo (Roma); Giovanni Passalacqua (Messina); Bianca Beghè (Modena); Salvatore Lo Cicero (Milano); Enzo Faccini (Dolo); Elena Atzeni (Nuoro); Roberto Tazza (Terni); Piercarlo Giamesio (Asti).

Author Contributions

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published and agreed to be accountable for all aspects of the work.

Disclosure

F.B. reports grants and personal fees from ASTRAZENECA, grants and personal fees from BAYER, personal fees from CHIESI, personal fees from GSK, personal fees from GUIDOTTI, grants and personal fees from GRIFOLS, grants from INSMED, personal fees from MENARINI, personal fees from NOVARTIS, grants and personal fees from PFIZER, personal fees from TEVA, personal fees from VERTEX, personal fees from ZAMBON, outside the submitted work. G.C. reports personal fees for speaker/advisory board fees from AstraZeneca, Chiesi, Menarini, Guidotti-Malesci, Erbazeta, during the conduct of the study; personal fees from AstraZeneca, Chiesi, Menarini, Erbazeta, Guidotti-Malesci, and Lusofarmaco, outside the submitted work. A.Z. and A.O. are employees of Medineos Observational Research. A.Z. reports personal fees from Laboratori Guidotti, during the conduct of the study; personal fees from Chiesi, Novartis, AstraZeneca, and Novonordisk, outside the submitted work. The other authors declare that they have no competing interests.

Additional information

Funding

Laboratori Guidotti and Malesci, Italy (https://www.labguidotti.it/; http://www.malesci.it) provided unconditional financial support to the study.