Fixed combination tiotropium/olodaterol in regular clinical practice: What do patients say?

Study Methodology and Objectives

The administration of long-acting muscarinic antagonists (LAMA) and long-acting β₂-agonists (LABA) represents the cornerstone of maintenance therapy for patients with moderate to very severe COPD according to the 2021 GOLD (Global Initiative for Chronic Obstructive Lung Disease) recommendations. Dual bronchodilation combining both types of drugs has proven clinical benefits and cost-effectiveness in these patients.

Clinical control of COPD from the patient's perspective can be assessed using tools like the Clinical COPD Questionnaire (CCQ). The CCQ is a validated, simple questionnaire that has been translated into 140 languages, includes 10 items, and takes approximately 2 minutes to complete. It was also used in a prospective non-interventional open study to evaluate changes in the clinical control of COPD in untreated and previously treated patients. Previous treatments included LAMA or LABA monotherapy, or a combination of LABA with inhaled corticosteroids (ICS).

The primary endpoint was the achievement of therapeutic success, defined as a reduction in the CCQ score by 0.4 points from baseline. Secondary endpoints included patient satisfaction and willingness to continue treatment.

Study Population

A total of 4,819 patients with COPD from 11 countries (Switzerland, Slovenia, Czech Republic, Poland, Hungary, Romania, Bulgaria, Lithuania, Ukraine, Russia, and Israel) were included, with their treating physician prescribing the fixed combination of tiotropium/olodaterol (LAMA/LABA) in the Respimat inhaler. A questionnaire was completed by 4,700 patients at the beginning and end of the treatment.

The average patient age was 65.4 years, with 69.7% of participants being men. Almost half (48.1%) of the patients were current smokers, and 42.5% were former smokers. GOLD B class COPD was determined in 51.6%, GOLD D in 42.7%, GOLD C in 5.5% of subjects, and 1 patient was classified as GOLD A. Comorbidities were reported in 66.5% of patients, with nearly half of these involving cardiovascular diseases. A total of 56.8% of patients were treatment-naive, 28.1% had previously used LAMA or LABA monotherapy, and 11.2% had used a combination of LABA + ICS. The median follow-up duration was 6 weeks.

Results

After 6 weeks, 81.4% of participants achieved therapeutic success. The overall CCQ score improved by an average of 1.02 points. Improvement in the score was observed in 92.2% of patients, no change in 2.5%, and worsening in 5.3%. The need for rescue medication decreased by 1.25 puffs per day. The greatest benefit was observed in previously untreated patients, with therapeutic success achieved in 85.7% of cases; in patients previously treated with a LABA + ICS combination, it was 79.5%, and in patients with previous LABA or LAMA monotherapy, it was 74.2%.

A total of 75.1% of patients were satisfied or very satisfied with the treatment, with the highest satisfaction expressed by previously untreated patients. Almost all patients (96.6%) were willing to continue treatment with the tiotropium/olodaterol combination after the study.

Adverse effects were rare and consistent with the known safety profile of this combination.

Conclusion

The use of the tiotropium/olodaterol combination, whether as initial treatment or after switching from LAMA or LABA monotherapy or from a LABA + ICS combination, led to clinical improvement according to the CCQ filled out by patients and reduced the need for rescue medication in real-world practice for patients with moderate to very severe COPD.
 

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Source:

Valipour A., Avdeev S., Szalai Z. Therapeutic success of tiotropium/olodaterol, measured using the Clinical COPD Questionnaire (CCQ), in routine clinical practice: a multinational non-interventional study. Int J Chron Obstruct Pulmon Dis 2021 Mar 10; 16: 615–628, doi: 10.2147/COPD.S291920.