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Aclidinium

AEMPS

Long-acting muscarinic antagonist for inhalation (LAMA)

ATC code: R03BB05

Brand names: Tudorza Pressair

Updated · Methodology

Indications

A

Chronic obstructive pulmonary disease

First line

Aclidinium is a LAMA for COPD maintenance. 2024 and GesEPOC 2021 place the LAMA class as foundational maintenance bronchodilation: aclidinium fits as monotherapy in group A, while a LABA+LAMA combination (aclidinium+formoterol: Brimica Genuair, Duaklir Genuair) covers groups B and E. The Cochrane 2018 network meta-analysis (Oba) found no advantage of aclidinium over other long-acting bronchodilators in exacerbations. Marketing as a «newest-generation LAMA with superior efficacy» is not supported.

Sources

  1. AEMPS: Ficha técnica de Aclidinio (Bretaris/Eklira Genuair) (2022)
  2. GOLD: Global Strategy for Diagnosis, Management and Prevention of COPD (2024)
  3. Cochrane: Long-acting muscarinic antagonists (LAMA) versus long-acting beta-agonists (LABA) and other LAMAs in COPD: network meta-analysis (2018)
  4. Arch Bronconeumol: Spanish COPD Guidelines (GesEPOC) 2021: Updated Pharmacological treatment of stable COPD (2022)

ICD-10: J44 · ICD-11: CA22

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Athletic endurance

Not recommended

Aclidinium is sometimes offered outside its licensed use «for endurance gains» in people without COPD. There is no benefit to expect: bronchodilation raises FEV1 only when baseline obstruction exists, and in a healthy person the airways are already open. WADA does not prohibit the drug. No convincing evidence supports an endurance benefit, and this is a prescription inhaler with its own adverse effects (dry mouth, rarely paradoxical bronchospasm), so there is no reason to take it without an indication. If aclidinium is suggested «to improve cardio» without a COPD diagnosis, discuss it with a second specialist.

Sources

  1. AEMPS: Ficha técnica de Aclidinio (Bretaris/Eklira Genuair) (2022)
F

Asthma

Not recommended

Aclidinium is not used in asthma. AEMPS and approved it for COPD only. A long-acting bronchodilator without an inhaled corticosteroid masks airway inflammation in asthma, so 2024 and GEMA 5.4 explicitly warn against such monotherapy because it raises the risk of severe exacerbations. The AEMPS ficha técnica also records anticholinergic adverse effects and a paradoxical bronchospasm warning. Among inhaled LAMAs, only tiotropium Respimat has been studied and approved as add-on therapy in severe asthma; aclidinium has never been studied in asthma. If aclidinium was prescribed for asthma, discuss the regimen with a second specialist.

Sources

  1. AEMPS: Ficha técnica de Aclidinio (Bretaris/Eklira Genuair) (2022)
  2. GINA: Global Strategy for Asthma Management and Prevention (2024)
  3. GEMA: Guia Espanola para el Manejo del Asma (GEMA 5.4) (2024)

ICD-10: J45 · ICD-11: CA23

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Competitive antagonist at muscarinic M1–M3 receptors of bronchial smooth muscle. Rapidly hydrolysed in plasma to inactive metabolites – systemic anticholinergic effects are smaller than with tiotropium. Dosed twice daily via the Genuair device with feedback (click and colour indicator confirm inhalation). Duration about 12 hours; comparable to tiotropium in exacerbations and FEV1 (Cochrane Network 2018).

Safety

Contraindications

  • Hypersensitivity to aclidinium, atropine or excipients
  • Angle-closure glaucoma (relative)
  • Symptomatic prostatic hyperplasia with urinary retention (relative)

Serious adverse effects

  • Paradoxical bronchospasm
  • Acute angle-closure glaucoma if the drug reaches the eye
  • Acute urinary retention
  • Anaphylactic reactions

Common adverse effects

  • Headache
  • Throat irritation
  • Cough
  • Dry mouth
  • Nasopharyngitis

Pregnancy: can you take Aclidinium?

EMA summary of product characteristics (section 4.6): there are no data on aclidinium bromide in pregnant women. Animal studies showed fetotoxicity only at doses far above the maximum human exposure. Aclidinium bromide is used during pregnancy only if the expected benefits outweigh the potential risks.

Breastfeeding: can you take Aclidinium?

Probably compatible. Hale L3. Systemic bioavailability is low. Continuation is decided individually with the pulmonologist.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions3 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • corticosteroidesclass named in the label
    «Aunque no se han realizado estudios de interacción farmacológica in vivo , el bromuro de aclidinio inhalado se ha utilizado de manera concomitante con otros medicamentos para la EPOC, incluidos…»

    AEMPS, section 4.5 · Open on CIMA

  • simpaticomiméticosclass named in the label
    «Aunque no se han realizado estudios de interacción farmacológica in vivo , el bromuro de aclidinio inhalado se ha utilizado de manera concomitante con otros medicamentos para la EPOC, incluidos…»

    AEMPS, section 4.5 · Open on CIMA

  • sympathomimeticsclass named in the label
    «Sympathomimetics, Methylxanthines, Steroids: In clinical studies, concurrent administration of aclidinium bromide and other drugs commonly used in the treatment of COPD including sympathomimetics…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Aclidinium used for?

Aclidinium is evaluated for the following indications with varying evidence strength: Chronic obstructive pulmonary disease (evidence tier A), Athletic endurance (evidence tier D), Asthma (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Aclidinium?

Common side effects of Aclidinium (≥ 1 in 100): Headache, Throat irritation, Cough, Dry mouth, Nasopharyngitis. See the Safety section for uncommon and serious reactions.

Is Aclidinium safe during pregnancy?

EMA summary of product characteristics (section 4.6): there are no data on aclidinium bromide in pregnant women. Animal studies showed fetotoxicity only at doses far above the maximum human exposure. Aclidinium bromide is used during pregnancy only if the expected benefits outweigh the potential risks.

Is Aclidinium compatible with breastfeeding?

Probably compatible. Hale L3. Systemic bioavailability is low. Continuation is decided individually with the pulmonologist.

Who should not take Aclidinium?

Aclidinium is contraindicated in: Hypersensitivity to aclidinium, atropine or excipients; Angle-closure glaucoma (relative); Symptomatic prostatic hyperplasia with urinary retention (relative). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Beclomethasone dipropionate, Budesonide, Budesonide/formoterol, Fluticasone, Formoterol, Montelukast, Salmeterol, Fluticasone propionate