Pediatric Subjects Aged 4 to 11 Years: The efficacy of Ventolin HFA was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric subjects aged 4 to 11 years with mild to moderate asthma. In this trial, subjects received Ventolin HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo. Serial pulmonary function measurements demonstrated that 2 inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo and that there were no significant differences between the groups treated with Ventolin HFA and CFC 11/12-propelled albuterol. In the responder population treated with Ventolin HFA, the mean time to onset of a 15% increase in peak expiratory flow rate (PEFR) over the pretreatment value was minutes, and the mean time to peak effect was approximately 90 minutes. The mean duration of effect as measured by a 15% increase in PEFR over the pretreatment value was greater than 3 hours. In some subjects, duration of effect was as long as 6 hours.
PROAIR HFA Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROAIR HFA Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, betaagonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PROAIR HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency , cardiac arrhythmias, and hypertension .
National Jewish Medical and Research Center: "Inhaled Medication with a Metered Dose Inhaler (MDI)."
Asthma Society of Canada: "How to Use Your Inhaler."
Science Daily: "New Asthma Inhaler Propellant Effective, But Costlier."
American College of Chest Physicians: "Using Your MDI-Closed Mouth Technique, Patient Education Guide."
American Academy of Allergy, Asthma & Immunology (AAAAI): "Cumulative effects of formoterol administered by a dry powder inhaler;" "Inhalers;" and "Anti-inflammatory effects of inhaled steroids delivered by HFA-MDI vs delivery by dry powder inhaler."
News release, Merck.
Boehringer Ingelheim: "US FDA Expands Approval of Tiotropium Respimat® for Maintenance Treatment of Asthma in Children."
FDA. Prescribing Information: Spiriva Respimat.