AIRFLUSAL FORSPIRO (fluticasone/salmeterol), corticosteroid/β2 agonist

PULMONOLOGY - New medicinal product
Opinions on drugs - Posted on Apr 14 2016

Reason for request

Inclusion

No clinical benefit demonstrated in asthma and COPD by comparison with SERETIDE DISKUS 500 µg/50 µg/dose.

  • AIRFLUSAL FORSPIRO has Marketing Authorisation in:

- Maintenance treatment of asthma in situations where the administration by inhalation of a product combining a corticosteroid and a long-acting β2 agonist bronchodilator is justified:

in patients who are inadequately controlled by inhaled corticosteroid therapy and “as-needed” dosing with an inhaled short-acting β2 agonist bronchodilator or

in patients controlled by inhaled corticosteroid therapy in combination with maintenance treatment with a long-acting inhaled β2 agonist.

- Symptomatic treatment of chronic obstructive pulmonary disease (COPD) in patients with an FEV1 (measured prior to administration of a bronchodilator) < 60% of the theoretical value and who have a history of repeated exacerbations and significant symptoms despite maintenance bronchodilator treatment.

  • No clinical benefit has been demonstrated by comparison with SERETIDE DISKUS 500 µg/50 µg/dose.

Clinical Benefit

Substantial

-

Moderate

Clinical Added Value

no clinical added value

-


Therapeutic use

-

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