Effects of aclidinium on determinants of COPD severity: symptoms and quality of life

Figures & data

Figure 1 Diagrammatic representation of the different features of COPD and of their mutual relationships, converging toward impairment of QoL and increased risk of mortality.

Notes: The decline in lung function, accompanied by airflow limitation, causing hyperinflation and dyspnea, is correlated with the extent of airway inflammation and contributes to parenchymal damage, which causes abnormal gas transfer with the consequent hypoxemia and hypercapnia, leading to pulmonary hypertension. The abnormal inflammatory response to noxious particles and gases is dependent on airway chronic inflammation and correlates with several comorbidities. These alterations are at the basis of nocturnal and whole-day symptoms and of reduced physical activity. All symptoms and limitations determine a poor QoL that is associated with an enhanced mortality risk.
Abbreviation: QoL, quality of life.

Figure 2 Changes from baseline SGRQ total score of ACCORD study²⁹ and ATTAIN study.²⁸ Notes: The results of ATTAIN study are related to the evaluation after 12 and 24 weeks of therapy. Data are reported as mean values.

Abbreviations: SGRQ, St George Respiratory Questionnaire; w, week; MCID, minimal clinically important difference.

Figure 3 Changes from baseline TDI score of ACCORD study²⁹ and ATTAIN study.²⁸

Notes: The results of ATTAIN study are related to the evaluation after 12 and 24 weeks of therapy. Data are reported as mean values.
Abbreviations: TDI, transitional dyspnea index; w, week; MCID, minimal clinically important difference.

Table 1 Effects of aclidinium bromide treatment on COPD clinical outcomes

Drug and doses, µg	Comparators	Study design	Population, n	COPD severity	Outcomes	Reference
Aclidinium bromide 400 μg bid	Tiotropium 18 μg qd and placebo	Phase IIa randomized, double-blind, double-dummy, crossover trial 2 weeks	30	Moderate to severe	Mean change from baseline in FEV1 AUC0–12/12 h at Day 15 of treatment Changes from baseline in daily COPD symptom scores Average daily use of relief medication	^Citation37
Aclidinium 200 μg, aclidinium 400 μg bid	Placebo	Phase III randomized, double-blind, placebo-controlled, parallel-group ATTAIN study 24 weeks	828	Postbronchodilator FEV1/FVC ratio of <70% and FEV1 <80% of the predicted value	Change from baseline in morning predose (trough) FEV1 at Week 24 Change from baseline in peak FEV1 Percentages of patients achieving clinically significant improvements in SGRQ total score TDI focal score	^Citation28
Aclidinium 200 μg, aclidinium 400 μg bid	Placebo	Phase III randomized, double-blind, multicenter trial 12 weeks ACCORD COPD I	561	Moderate to severe	Changes from baseline in trough FEV1 at Week 12 Health status (SGRQ) TDI Night and early morning symptoms, Safety profile	^Citation29
Aclidinium 400 μg bid	Aclidinium 200 μg bid	Double-blind, 1-year extension study of ACCORD COPD I	291	Moderate to severe	Long-term safety and tolerability of aclidinium treatment	^Citation30

Abbreviations: FEV₁, forced expiratory volume in 1 second; bid, twice daily; qd, once daily; FVC, forced vital capacity; AUC_x–y, area under the curve from time x to time y; SGRQ, St George’s Respiratory Questionnaire; TDI, transitional dyspnea index; COPD, chronic obstructive pulmonary disease.

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