Aclidinium Bromide; Formoterol
Aclidinium bromide-formoterol is a maintenance bronchodilator treatment for symptom relief in adults with chronic obstructive pulmonary disease (COPD).
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
60%
40%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
No data on use in pregnancy or lactation were identified in the available sources. Decisions on treatment should follow official prescribing information and clinical guidelines.
Sex-specific non-clinical findings
In rats, slight reductions in fertility were seen only at exposures much higher than the maximum human exposure to aclidinium and formoterol; an effect at the recommended human dose is considered unlikely.
Disease prevalence by sex
Men
60%
Women
40%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
No data on use in pregnancy or lactation were identified in the available sources. Decisions on treatment should follow official prescribing information and clinical guidelines.
Sex-specific non-clinical findings
In rats, slight reductions in fertility were seen only at exposures much higher than the maximum human exposure to aclidinium and formoterol; an effect at the recommended human dose is considered unlikely.
General information
General Efficacy
Primary endpoints: In the two 6-month pivotal Phase III studies, the co-primary endpoints were FEV1 at 1 hour post-dose and trough FEV1, to demonstrate the bronchodilator contributions of formoterol and aclidinium, respectively. In the 8-week hyperinflation study, the primary endpoint was change from baseline in morning pre-dose (trough) functional residual capacity after 4 weeks. Secondary endpoints: Supportive endpoints included additional lung function measures, breathlessness and symptom outcomes (Transition Dyspnoea Index focal score and E-RS total score), disease-specific health status (St. George’s Respiratory Questionnaire total score and responder rates), rate of moderate or severe COPD exacerbations and time to first exacerbation, rescue medication use, lung volumes at 2-3 hours post dose, exercise endurance time, physical activity measures (steps/day, percentage of inactive patients, PROactive total score), and night-time/early morning symptoms.
General Posology
One inhalation of the 340 micrograms/12 micrograms inhalation powder twice daily by inhalation. If a dose is missed, it should be taken as soon as possible and the next dose taken at the usual time; a double dose should not be taken. No dose adjustments are required in elderly patients or in patients with renal or hepatic impairment. There is no relevant use in children and adolescents under 18 years of age for COPD.
Further Dose Adjustments
No dose adjustment is required in elderly patients or in patients with renal or hepatic impairment; there is no relevant use in children and adolescents under 18 years of age for COPD. The medication is contraindicated in hypersensitivity to the active substances or lactose monohydrate and should not be used in patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
Possible Side Effects
The most frequently reported adverse reactions were nasopharyngitis (7.9%) and headache (6.8%), both listed as common. Clinically important serious or potentially serious reactions reported included hypersensitivity, angioedema, anaphylactic reaction, bronchospasm including paradoxical bronchospasm, and cardiac arrhythmias including atrial fibrillation and paroxysmal tachycardia. Reasons for discontinuation were not reported in the provided text.
Contraindications
Hypersensitivity to the active substances or to lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take the medication.
Clinical Trial Type and Population
The safety and efficacy population comprised approximately 4,000 patients with a clinical diagnosis of COPD in the Phase III programme; the provided text does not report study-level mean/median age or percentage of women. Major studies: ACLIFORM-COPD (n not reported; mean/median age not reported; women not reported), AUGMENT (n not reported; mean/median age not reported; women not reported), and a further 12-month randomised controlled study (n not reported; mean/median age not reported; women not reported). A total of 1222 patients received the 340 micrograms/12 micrograms strength.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Date of first authorisation:
19 November 2014
Source URL:
Prevalence Source: