Paradigm Shift in Asthma Therapy for Adolescents Should It Apply to Younger Children as Well?

Source: JAMA Pediatrics Published online January 6, 2020


Background Knowledge


  1. GINA presented a significant change in asthma therapy.
  2. Step 1 recommendations for mild asthma in adolescents 12 years and older and adults changed from as-needed short-acting β-agonist (SABA) to as-needed low-dose inhaled corticosteroid (ICS) formoterol (a long-acting β-agonist [LABA]).
  3. In children aged 6 to 11 years, GINA recommends that ICS therapy be used with SABA as needed or regular ICS with as needed SABA as an alternative approach.

Why was it changed ?

It was because the SABA only had shown to increase mortality also various trials have shown superiority.

What were the trials?

SYGMA 1 and 2
NovelSTART studies

What is SYGMA1 and SYGMA2?

Both these trials had randomised adoslescents and adults into 3 groups
  1. Budesonide maintenance and as needed terbutaline
  2. Budesonide and formeterol as needed
  3. only as needed terbutaline
  4. Twice daily placebo in all groups
Conclusion:
Budesonide maintenance and Budesonide formeterol had same annualised exacerberation rate however dose of ICS was drastically low in AS needed ICS-formeterol group.

What is NovelSTART?

Similar randomisation as SYGMA

Similar results

BUT ONLY OLDER PATIENTS WERE ENROLLED.

➽2 randomised control trials are available for comparision of the use of combination ICS plus LABA or ICS plus SABA as maintenance and reliever therapy.
                                                                          ⤋
Exacerbations were significantly reduced in the single inhaler group (P < .001), with approximately one-half dose extra per day of combined budesonide-formoterol, with no effect on linear growth.

What is TREXA ( TREATING CHILDREN TO PREVENT EXACERBERATION OF ASTHMA) STUDY?

Study groups were:

Children aged 5 to 18 years with mild persistent asthma controlled receiving low-dose ICS were randomized to 1 of 4 treatment groups:
  1. twice daily beclomethasone with beclomethasone/albuterol (SABA) as reliever (combined group),
  2. twice-daily beclomethasone with placebo/albuterol as reliever (daily beclomethasone group),
  3. twice-daily placebo with beclomethasone/albuterol as reliever (rescue beclomethasone group), or
  4. twice-daily placebo with placebo/albuterol as rescue (placebo group)
Conclusion :
Significant increase in FEV1 in the placebo and rescue beclomethasone groups (P = .001 and P = .02, respectively).
There were increases in fractional exhaled nitric oxide in the rescue beclomethasone and placebo groups compared with the combined and daily beclomethasone groups.

What is INDIVIDUALISED THERAPY FOR ASTHMA IN TODDLERS(INFANT) 

THIS TRIAL Randomized 300 children aged 12 to 59 months requiring daily asthma controller therapy to
Daily ICS,
Daily leukotriene receptor antagonist, or
As-needed ICS with albuterol.
The group that did best with daily ICS therapy had increased eosinophils and/or allergic sensitization

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