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.
5. Thinking a written prescription for a COPD inhaler means
the patient knows when to use it: The drug's purpose.
For treatment purposes all inhalers for COPD & asthma fall into one of
two broad categories:
a) to provide quick relief ('rescue inhalers') and
b) to improve chronic symptoms and prevent flareups ('maintenance inhalers'). Examples of rescue inhalers are albuterol (brand names Proventil HFA, ProAir HFA, Ventolin HFA) and ipratropium bromide (brand name Atrovent). Combivent contains a combination of albuterol and ipratropium bromide. Maintenance inhalers include any inhaled steroid (IS), either alone (brand names Azmacort, Qvar, Pulmicort, etc.) or in combination with a 'long acting bronchodilator' (LABD; brand names Symbicort, Advair). PROBLEM: The SAME type of delivery device (size, shape, mechanism of action) is commonly used for both rescue and maintenance inhalers. For example, as shown below, ProAir HFA (a rescue inhaler, on left) and Symbicort (a maintenance inhaler, on right) both come packaged as pressurized metered dose inhalers, and both are deep red in color. There is nothing intuitive about this. For a patient who may have both inhalers (quite common), and who becomes short of breath, it is all too easy to forget which is which.
Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea , or chest tightness). VENTOLIN HFA or placebo HFA was delivered with either an AeroChamber Plus® Valved Holding Chamber or an Optichamber® Valved Holding Chamber with mask 3 times daily. In one trial, VENTOLIN HFA 90 mcg (n = 26), VENTOLIN HFA 180 mcg (n = 25), and placebo HFA (n = 26) were administered to children aged between 24 and 48 months. In the second trial, VENTOLIN HFA 90 mcg (n = 29), VENTOLIN HFA 180 mcg (n = 29), and placebo HFA (n = 28) were administered to children aged between birth and 24 months. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving VENTOLIN HFA 90 mcg, VENTOLIN HFA 180 mcg, and placebo in either trial.