Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1   Pharmacodynamic properties

Pharmacotherapeutic group: Selective beta2-adrenergic agonist, ATC code: R03AC13.

Formoterol is a potent selective β2-adrenergic stimulant. It exerts a bronchodilator effect in patients with reversible airways obstruction. The effect sets in rapidly (within 1-3 minutes) and is still significant 12 hours after inhalation.

In man, Foradil has been shown to be effective in preventing bronchospasm induced by exercise and methacholine.

Formoterol has been studied in the treatment of conditions associated with COPD, and has been shown to improve symptoms and pulmonary function and quality of life. Formoterol acts on the reversible component of the disease.

Serious asthma exacerbations

Placebo-controlled clinical studies of at least 4 weeks treatment duration with Foradil suggested a higher incidence of serious asthma exacerbations in patients who received Foradil than in those who received placebo, particularly in patients 5-12 years of age.



FOR API APR21 V8                                                    Ref: UK SmPC Dec2019 Placebo     Foradil 12 ug bd       Foradil 24 Albuterol ug bd
Placebo controlled clinical     0.3 %       0.9 %                  1.9 % studies of at least 4 weeks                 (Foradil 10 - 12 ug treatment duration.                         bd)
Combined data from two          0.7 %       0.4 %                  3.3 %        0.7 % 12-week double-blind,           ( 2/277 )   ( 1/275 )              ( 9/271 )    ( 2/272 ) randomized, placebo- controlled, parallel-group studies.
Age >12 y n=1095
Multi-centre, randomized,       0.2 %       0.6 % ( 3/527 )        0.4 % parallel-group, double-blind,   ( 1/514 )                          ( 2/527 ) placebo-controlled 16 week                  0.2 % ( 1/517 ) trial.                                      Open label treatment
Age >12 y                                   group - 12 ug bd n=2085                                      plus up to two additional doses per day

Randomized, placebo-        0.0 %           4.7 %                  6.4 % controlled double-blind 52- ( 0/176 )       ( 8/171 )              ( 11/171 ) week trial.
Age 5-12 y n=518

Experience in children aged 5-12 years with asthma
The safety of Foradil 12 microgram twice daily compared to Foradil 24 microgram twice daily and placebo was investigated in one large, multicenter, randomized, double-blind, 52- week clinical trial in 518 children with asthma (ages 5 to 12 years) in need of daily bronchodilators and anti-inflammatory treatment. More children who received Foradil 24 microgram twice daily (11/171, 6.4%) or Foradil 12 microgram twice daily (8/171, 4.7%) than children who received placebo (0/176, 0.0%) experienced serious asthma exacerbations.

Pharmacokinetic Properties