Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Alvesco (Altana Pharma)
metered dose inhalers delivering 80 microgram or 160 microgram per actuation
Approved indication: asthma prophylaxis
Australian Medicines Handbook section 19.2

Inhaled corticosteroids can have an important role in helping patients with asthma achieve their best lung function. Ciclesonide is a non-halogenated glucocorticosteroid which is claimed to have a finer aerosol than other drugs, so less of the dose is deposited in the oropharynx. In the lung, ciclesonide is metabolised to its active metabolite which has a higher affinity for glucocorticoid receptors. Although ciclesonide has a different structure, it still acts like other inhaled corticosteroids by reducing bronchial hyper-reactivity and inflammation in the airways.

The active metabolite is metabolised by cytochrome P450 3A4, so drugs which inhibit this enzyme may increase plasma concentrations of the metabolite. The clinical significance of this interaction with inhaled ciclesonide is unclear. Ciclesonide and its metabolites are mainly excreted in the faeces.

The effect of ciclesonide has been compared with placebo in a double-blind crossover trial of 13 asthmatic patients given an allergen challenge. After inhaling powdered ciclesonide for a week before the challenge the patients' forced expiratory volumes (FEV1) decreased significantly less than they did after one week of placebo.1

Although ciclesonide is more active than placebo it is unclear if it has any greater efficacy than other drugs such as budesonide. The product information says there have been 16 trials of ciclesonide, but few of them seem to have been published in full by peer-reviewed journals. As only five studies of 12 weeks' duration are briefly summarised in the product information, it is difficult to assess the long-term effectiveness of ciclesonide in asthma.

In theory, the deposition of most of the dose in the lung and ciclesonide's lower affinity for the glucocorticoid receptors should reduce some of the problems associated with inhaled corticosteroids. The common adverse effects of ciclesonide include hoarseness and bronchospasm, but the incidence of long-term adverse effects such as adrenal suppression and cataracts is unknown. It is not approved for use by children under 12 years old.

Although ciclesonide has the convenience of a once-daily dose, its place in therapy is unclear. Until more data are made available for scrutiny, there seems to be little justification for doctors to add ciclesonide to their choice of inhaled corticosteroids.

manufacturer did not respond to request for data

The Transparency Score ( ) is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.

Notes on references

At the time the comment was prepared, information about this drug was available on the website of the Food and Drug Administration in the USA (www.fda.gov).

At the time the comment was prepared, a scientific discussion about this drug was available on the website of the European Agency for the Evaluation of Medicinal Products (www.emea.eu.int).

References

  1. Larsen BB, Nielsen LP, Engelstätter R, Steinijans V, Dahl R. Effect of ciclesonide on allergen challenge in subjects with bronchial asthma. Allergy 2003;58:207-12.