A randomised controlled trial of short term growth and collagen turnover in asthmatics treated with inhaled formoterol and budesonide.
OBJECTIVE
To determine effects on short term growth and collagen turnover of adding formoterol (Eformoterol) to half the glucocorticoid dose in children with asthma, treated with inhaled budesonide (Pulmicort Turbuhaler).


METHODS
A randomised double blind, placebo controlled crossover study with two six-week periods.


METHODS
Outpatient clinic in secondary referral centre.


METHODS
A total of 27 prepubertal children aged 6-13 years.


METHODS
Formoterol 12 microg and dry powder budesonide 100 microg twice daily in one period; placebo and dry powder budesonide 200 microg twice daily in the other.


METHODS
Primary outcome measures were lower leg growth rate, and serum and urine markers of type I and type III collagen turnover. Secondary outcome measures were inflammation markers in serum, and parameters of asthma control.


RESULTS
During budesonide 200 microg twice daily treatment, mean lower leg growth rate was 0.14 mm/week (p = 0.02) lower than during the formoterol and budesonide period. Similar statistically significant effects on markers of collagen turnover were found, whereas inflammation markers and asthma control did not vary statistically significantly between the two periods.


CONCLUSIONS
In children treated with inhaled glucocorticoids, halving the dose and adding formoterol is associated with faster short term growth and an increase in markers of collagen turnover, with no loss of asthma control.
Heuck
C
C
Department of Paediatrics, Skejby Sygehus, Aarhus University Hospital, Aarhus, Denmark.
Heickendorff
L
L
Wolthers
O D
OD
D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000494:pharmacology / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000494:pharmacology / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000494:pharmacology*; D019819:Budesonide / Q000494:pharmacology / Q000627:therapeutic use; D002648:Child; D003094:Collagen / Q000378:metabolism*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D000068759:Formoterol Fumarate; D006128:Growth / Q000187:drug effects*; D006801:Humans; D007866:Leg / Q000254:growth & development; D008297:Male
D000318:Adrenergic beta-Agonists; D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D003094:Collagen; D000068759:Formoterol Fumarate