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ProAir RespiClick Now Approved for Children

The U.S. Food and Drug Administration (FDA) has expanded the indication for albuterol inhalation powder (ProAir® RespiClick by Teva Respiratory) to children aged 4 to 11 years.  ProAir® RespiClick is now indicated for the treatment or prevention of asthma and for prevention of exercise-induced asthma in patients aged 4 years and older. The FDA approved ProAir RespiClick for use in patients aged 12 and older in March 2015, and it remains the only FDA-approved breath-activated, multi-dose, dry powder, short-acting beta-agonist inhaler available in the U.S.

In the U.S., childhood asthma affects more than 6 million patients, and that number is rising.  For this young population of asthma patients, learning to use inhalers properly can be very challenging.  The pediatric indication for ProAir® RespiClick is important as it represents a new rescue inhaler option for younger patients that eliminates the need for hand-breath coordination during inhalation and was designed to be used without a spacer.  Spacers or “holding chambers” are used commonly with other traditional inhalers and can be expensive and not always covered by health insurance.

The pediatric approval of ProAir® RespiClick follows the FDA’s review of data from Teva’s phase 3 clinical trial program that evaluated the safety and efficacy (effectiveness) of the treatment in patients with asthma as young as 4 years.  Data showed that treatment with ProAir RespiClick led to significantly greater improvement in lung function (forced expiratory volume) compared with placebo.

Other advantages of Proair RespiClick:

  • No spacer or holding chamber needed.
  • No shaking
  • Easy to inhale

Common adverse effects in patients 12 years of age and older using ProAir® RespiClick include back pain, body aches and pains, upset stomach, sinus headache, and UTI.  Common adverse effects in children 4 to 11 years of age using the inhaler include upper respiratory infections, mouth and throat pain and vomiting.

Potential Disadvantage:

  • Children with milk anaphylaxis should not use the RespiClick device as the dry powder contains lactose (milk sugar) and there is a possibility of small amounts of milk protein.

At Family Allergy & Asthma Care of Montana, we believe in using the least amount of medication necessary to control and prevent asthma.  Bottom line: new inhaler devices like RespiClick are making it easier to use for children (and adults) and a spacer is not needed.  That is a double bonus!

This information is solely for informational purposes and not intended as a substitute for consultation with a medical professional.

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