MucoClear® 6% [hypertonic saline] harmful for children under 6 years?

Question

Hello,

I have a question regarding MucoClear® 6% [NaCl 6%]. Since our health insurance does not pay the 3% NaCl our outpatient clinic prescribes MucoClear® 6% for our three-year-old daughter that we mix with 0,9% NaCl.
Some days ago we made an inquiry at "ACHSE" (German alliance for chronic rare disease) because we wanted to know why some patients are paid MucoClear® 6% for their children under 6 years and others not. The following answer was given:

"The group of people was limited as follows:
"For symptomatic inhalation treatment of cystic fibrosis for patients from age six". This prescribability is limited to 15th of August 2012. Then, a new assessment will be done. Up do date there has been no study confirming that MucoClear® 6% is not harmful to health for children under 6 years."

The last sentence has irritated me a bit and I would like to ask inhowfar MucoClear® 6% is harmful to health for children under 6 years or what kind of harm it does to children.

Thank you for your answer.

Answer

Hello,

You are saying that your 3-year-old daughter currently inhales with MucoClear® 6% mixed with NaCl 0,9% since MucoClear® 3% is not paid by the health insurance. Furthermore, you heard that Mucoclear 6% cannot be prescribed until 15Th of August 2012 [for children under 6 years] and that then a news assessment will be done and that it is not clear at the moment whether Mucoclear® 6% is harmful to health for children under 6 years.

In this context it can be said that the first studies with MucoClear® 6% in children from age 6 were made. Based on this approval study the prescription is limited to children that are 6 years or older. In the scope of this study the harmlessness of the therapy was proven for the tested age group, not for younger children, though. This does not mean automatically that MucoClear® can be harmful to health. It is, however, not proven by a study that there are no harmful side effects for younger children.
For your 3-year-old daughter I would not necessarily suggest the inhalation with MucoClear® 6% since some children react with bronchial stenosis when inhaling higher concentrated MucoClear®. If you child is tolerating the current mixture you should proceed as usual.

Best regards,
Dr. H.-G. Posselt

24.04.2012

24.4.12
Concerning hypertonic saline soultion for inhaltion in younger children, there is limited data available on the safety:
"Inhaled hypertonic saline in infants and toddlers with cystic fibrosis: short-term tolerability, adherence, and safety." Rosenfeld M et. al in Pediatric Pulmonology 2011 Jul;46(7). 666-71.
An investigation on efficacy is performed at the moment in Canada.
D. d'Alquen