MucoClear® 6% (hypertonic saline solution) harmful for children under 6? [follow-up question]

Question

My 3,5-year-old daughter (CF) inhales MucoClear® 6% [NaCl 6%] and tolerates it well, she has no bronchial problems; we do inhale 2 puffs Salbutamol previously to avoid bronchial constriction.
Can we continue this way without concerns? Or can this be harmful. It is dissolving very well.
Thank you.

Answer

Hello,

[Remark: This question seems to be a follow-up question to the other question about MucoClear®; please also read these earlier questions&answers about the topic with the subject " MucoClear® 6% harmful for children under 6 years?". Please click on "Search" (right column of this site) and enter the word mucoclear ]

Based on the approval studies, the use of MucoClear® 6% is limited to the age group of children from age six. The reason for this is that the studies were only made with children that were age six or older. If your attending physician suggested this treatment in mutual agreement with you for your 3,5-year-old daughter, he/she is authorised to do this. If your daughter is tolerating MucoClear® 6% well after having inhaled Salbutamol previously, this confirms the assumption that this therapy is tolerated with a certain level of assurance by younger patients as well. However, it has to be stressed that there are no controlled studies that are proving the safe long-term use in this age group (under six).

We hope that your daugher keeps on benefitting from this therapy without side effects.

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