A Cross-Sectional Study in Patients with Severe COPD to Assess the Perception of Symptom Variability (COPVAR) in the Middle East and Africa

Abstract

Purpose

This study was performed to assess symptom variability and its impact on morning activities in stable patients with severe COPD in the Middle East and Africa (MEA) countries.

Patients and methods

Non-interventional, cross-sectional study (NCT3425760) in patients with severe COPD (GOLD 2015, C, or D categories). Symptom variability was assessed directly by interviewing the patient and using the Global Chest Symptoms Questionnaire (GCSQ). The impact on morning activities was assessed using the Capacity of Daily Living during the Morning (CDLM) and the Morning Activities and Symptoms Questionnaire (MASQ).

Results

A total of 3253 patients (mean±SD age: 64.1±9.5 years, 90.3% males) were enrolled. Overall, 81.6% and 83.4% of patients reported weekly and daily symptom variability, respectively. The number of exacerbations in the previous year, smoking cessation, and COPD GOLD D were the most consistent factors associated with symptom variability. The GCSQ score was significantly higher (p<0.001) in GOLD D than in GOLD C patients at each time during the day. In GOLD D, the mean (±SD) GCSQ score was higher at night (1.6±1.2, p<0.001) and in the morning (1.5±1.0, p<0.001) than in the afternoon (1.3±0.9), suggesting daytime variability of breathlessness and chest tightness. Overall, 60.0% of GOLD D patients (versus 13.6% GOLD C, p<0.0001) had difficulty getting out of bed due to COPD. Patients with symptom variability had significantly more difficulty to get out of bed, especially patients with chest tightness variability (p<0.0001) and wheezing variability (p<0.0001). The CDLM global score was significantly lower (p<0.0001) in GOLD D than in GOLD C patients (3.5±1.1 and 4.6 ± 3.5, respectively). Daily variability in chest tightness and wheezing was also significantly associated with CDLM scores (p<0.0001).

Conclusion

In MEA countries, patients with severe stable COPD reported significant daily and weekly symptom variability which affects morning activities, particularly in GOLD D patients.

Keywords:

• breathlessness
• exacerbation
• GOLD C
• GOLD D
• quality of life

Acknowledgments

The authors would like to thank all investigators who enrolled patients in this study. To NCT (Cairo, Egypt) for clinical study management, Axonal-Biostatem (Castries, France) for data management and statistics, and Thierry Radeau Consulting (Epinay-Sous-Senart, France) for medical writing support funded by AstraZeneca (United Arab Emirates) in accordance with Good Publication Practice (GPP3) guidelines (https://www.ismpp.org/gpp3).

Ethics Committee (EC) or Institutional Review Board (IRB) Consulted

Egypt (Central Directorate of Research & Health Development, Ministry of Health & Population, Cairo); UAE (Zayed Military Hospital Ethics Committee; Rashid Hospital, DHA, Dubai Scientific Research EC; Al Ain Hospital Research & Ethics Governance Committee); Kuwait (MOH-Kuwait); Qatar (Hamad Medical Center Institutional Review Board); Turkey (Gazi University Clinical Trials Ethics Committee); Kingdom of Saudi Arabia (Research & Ethics Committee, King Abdulaziz Air Base Hospital; King Abdulaziz Medical City Hospital-Riyadh, King Abdullah International Medical Research center IRB; King Abdulaziz University Hospital-Jeddah unit of Biomedical Ethics and Research committee; King Faisal Specialized Hospital & Research Center – clinical research committee; King Fahd Medical City IRB, King Saud Medical City IRB); Algeria (University Hospital Beni-Messous, Issad Hassani Hospital Ethics Committee); South Africa (Richard van Zyl-Smit Pharma Ethics Ltd, University of Stellenbosch Respiratory Research Unit Health Research Ethics Committee; UCT Lung Institute, Faculty of Health Sciences Human Research Ethics Committee, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand Johannesburg Human Research Ethics Committee).

Disclosure

NK received a grant from AstraZeneca during the conduct of the study. RVZS received personal fees from AstraZeneca, Novartis, GSK, Chiasi, Cipla, Pfizer, Aspen, Roche and MSD, and grants and personal fees from GSK, outside of the submitted work. ASA received funds from AstraZeneca to conduct the study. WA and EM are employees at AstraZeneca. The authors report no other conflicts of interest in this work.