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In the 2 controlled 12-week studiesCOMBIVENT Inhalation Aerosol did not produce any change in the secondary efficacy parameters including symptom scoresphysician global assessments and morning PEFRall of which were monitored throughout the study period.
Activation of beta 2adrenergic receptors on airway smooth muscle leads to the activation of adenylyl cyclase and to an increase in the intracellular concentration of cyclic-35adenosine monophosphatecyclic AMPThis increase of cyclic AMP leads to the activation of protein kinase Awhich inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrationsresulting in relaxationAlbuterol relaxes the smooth muscles of all airwaysfrom the trachea to the terminal bronchiolesAlbuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involvedthus protecting against all bronchoconstrictor challengesIncreased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway.
Albuterol has been shown in most clinical trials to have more bronchial smooth muscle relaxation effect than isoproterenol at comparable doses while producing fewer cardiovascular effectsHoweverall beta-adrenergic drugsincluding albuterol sulfatecan produce a significant cardiovascular effect in some patientssee PRECAUTIONS
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long term chronic use safety data for combivent respimatwere obtained from one 48-week, randomized, multi-center, open-label,parallel-group trial that compared atrovent comp ipratropium bromide 20 100 mcg ,cfc-propelled combivent inhalation aerosol 36 206 mcg and the freecombination of atrovent comp ipratropium bromide bromide 34 mcg and albuterol 180 mcg hfa inhalation aerosols administered 4 times a day in 465 adult copdpatients 273 males and 192 females 40 years of age and older.