Aclidinium bromide
Aclidinium bromide is an inhaled long-acting anticholinergic bronchodilator for maintenance treatment of symptomatic chronic obstructive pulmonary disease (COPD) in adults.
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
58.7%
41.3%
Representation Gap
No sex-specific data
-1.3%
+1.3%
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific efficacy differences were reported; overall, aclidinium bromide produced clinically meaningful and sustained improvements in FEV1 (e.g. ~128 mL trough FEV1 gain vs placebo at 6 months) and reduced moderate/severe COPD exacerbations and COPD-related hospitalisations, with symptomatic benefits in dyspnoea, health status and exercise tolerance.
Sex-specific posology
No sex-specific data
The recommended dose is one inhalation of 322 micrograms aclidinium bromide twice daily by inhalation; if a dose is missed it should be taken as soon as possible unless it is nearly time for the next dose, in which case the missed dose should be omitted.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific differences in the type or frequency of adverse reactions were reported; common reactions included headache, nasopharyngitis, sinusitis, cough, diarrhoea and nausea, with uncommon anticholinergic effects such as dry mouth, urinary retention and cardiac arrhythmias, and rare serious hypersensitivity reactions including angioedema and anaphylaxis.
Pregnancy / lactation
N / A
There are no data on use of aclidinium bromide in pregnancy; animal data show foetotoxicity only at exposures much higher than human, so use in pregnancy should be restricted to situations where expected maternal benefit outweighs potential risk. It is unknown whether aclidinium bromide or its metabolites are excreted in human milk, although small amounts were found in animal milk; a risk to breastfed infants cannot be excluded, so a decision is required to discontinue breast-feeding or discontinue/abstain from therapy. Slight reductions in fertility were seen only at very high exposures in animals and are not expected at the recommended human dose.
Sex-specific non-clinical findings
No sex- or gender-specific non-clinical safety findings have been reported beyond high-dose reproductive toxicity at exposures far exceeding those achieved in humans.
Disease prevalence by sex
Men
60%
Women
40%
Clinical study participation by sex
Men
58.7%
Women
41.3%
Representation Gap
No sex-specific data
Men
-1.3%
Women
+1.3%
Sex-specific efficacy/accuracy
No sex-specific data
No sex-specific efficacy differences were reported; overall, aclidinium bromide produced clinically meaningful and sustained improvements in FEV1 (e.g. ~128 mL trough FEV1 gain vs placebo at 6 months) and reduced moderate/severe COPD exacerbations and COPD-related hospitalisations, with symptomatic benefits in dyspnoea, health status and exercise tolerance.
Sex-specific posology
No sex-specific data
The recommended dose is one inhalation of 322 micrograms aclidinium bromide twice daily by inhalation; if a dose is missed it should be taken as soon as possible unless it is nearly time for the next dose, in which case the missed dose should be omitted.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific differences in the type or frequency of adverse reactions were reported; common reactions included headache, nasopharyngitis, sinusitis, cough, diarrhoea and nausea, with uncommon anticholinergic effects such as dry mouth, urinary retention and cardiac arrhythmias, and rare serious hypersensitivity reactions including angioedema and anaphylaxis.
Pregnancy / lactation
Men
N / A
Women
There are no data on use of aclidinium bromide in pregnancy; animal data show foetotoxicity only at exposures much higher than human, so use in pregnancy should be restricted to situations where expected maternal benefit outweighs potential risk. It is unknown whether aclidinium bromide or its metabolites are excreted in human milk, although small amounts were found in animal milk; a risk to breastfed infants cannot be excluded, so a decision is required to discontinue breast-feeding or discontinue/abstain from therapy. Slight reductions in fertility were seen only at very high exposures in animals and are not expected at the recommended human dose.
Sex-specific non-clinical findings
No sex- or gender-specific non-clinical safety findings have been reported beyond high-dose reproductive toxicity at exposures far exceeding those achieved in humans.
General information
General Efficacy
Not reported
General Posology
Not reported
Further Dose Adjustments
Not reported
Possible Side Effects
No very common (≥1/10) adverse reactions are reported. The most frequently reported adverse reactions were headache (6.6%) and nasopharyngitis (5.5%). Common adverse reactions (≥1/100 to <1/10) included sinusitis, nasopharyngitis, headache, cough, diarrhoea and nausea. Uncommon adverse reactions (≥1/1,000 to <1/100) included dizziness, blurred vision, cardiac arrhythmias including atrial fibrillation and paroxysmal tachycardia, tachycardia, palpitations, dysphonia, dry mouth, stomatitis, rash, pruritus and urinary retention. Rare and not‑known frequency immune‑mediated reactions included hypersensitivity (rare), angioedema (not known) and anaphylactic reaction (not known). Cardiac arrhythmias and serious hypersensitivity reactions (including angioedema and anaphylaxis) are clinically important adverse reactions highlighted in the safety information.
Contraindications
Not reported
Clinical Trial Type and Population
Not reported
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication