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Evaluation of fluticasone propionate and fluticasone propionate/salmeterol combination on exercise in pediatric and adolescent patients with asthma.

Murray JJ, Waitkus-Edwards KR, Yancey SW - Open Respir Med J (2011)

Bottom Line: A mean decrease in FEV(1) of 9.9% was observed in the FSC 100/50 group as compared with a mean decrease of 11.1% in the FP 100 group; there was no statistical difference between treatments.Both FSC 100/50 and FP 100 provided protection against an exercised-induced fall in FEV(1); but statistically significant differences we not noted.Both treatments were well-tolerated over four weeks and FSC 100/50 had an adverse event profile comparable to that observed with FP 100.

View Article: PubMed Central - PubMed

Affiliation: Internal Medicine, Meharry Medical College, Nashville, TN, USA.

ABSTRACT

Objective: This study was designed to demonstrate that four weeks of fluticasone propionate (FP) 100 micrograms (mcg) combined with salmeterol 50 mcg twice daily (BID) via DISKUS(®) resulted in protection against bronchospasm induced by activity, as measured by standardized exercise challenge testing in pediatric and adolescent subjects who required regular use of inhaled corticosteroids for the treatment of persistent asthma.

Methods: Prior to study entry, all patients reported regular use of inhaled corticosteroids (ICS). During screening all patients demonstrated ≥20% fall in FEV(1) following exercise.

Results: A total of 231 subjects aged 4 to 17 were randomized to the two study treatments: 113 to the FP/salmeterol combination group (FSC) and 118 to receive FP 100 mcg BID. Of the subjects randomized, 106 (94%) subjects in the FSC 100/50 group and 108 (92%) subjects in the FP 100 group completed the study. At the end of treatment (Week 4), both FSC and FP protected against a fall in FEV(1) following exercise in patients who at baseline experienced ≥20% fall in FEV(1) following exercise. A mean decrease in FEV(1) of 9.9% was observed in the FSC 100/50 group as compared with a mean decrease of 11.1% in the FP 100 group; there was no statistical difference between treatments.

Conclusion: Both FSC 100/50 and FP 100 provided protection against an exercised-induced fall in FEV(1); but statistically significant differences we not noted. Both treatments were well-tolerated over four weeks and FSC 100/50 had an adverse event profile comparable to that observed with FP 100.

No MeSH data available.


Related in: MedlinePlus

Number of patients screened, and number of subjects enrolled, randomized, completed, and withdrawn.
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Figure 1: Number of patients screened, and number of subjects enrolled, randomized, completed, and withdrawn.

Mentions: Patients screened for the study reported using ICS for at least 28 days prior to screening at a daily dosage of no more than: 264 mcg of FP metered-dose inhaler (MDI), 600 mcg of budesonide, 504 mcg of beclomethasone dipropionate, 1000 mcg of flunisolide, or 1000 mcg of triamcinolone acetonide. A total of 707 subjects were screened for the study; the majority of screen failures were due to inability to demonstrate the required drop of FEV1 following exercise challenge. A total of 231 subjects were randomized to the two study treatments: 113 to the FSC 100/50 group and 118 to FP 100. Of those randomized, 106 (94%) subjects in the FSC 100/50 group and 108 (92%) subjects in the FP 100 group completed the study (Fig. 1).


Evaluation of fluticasone propionate and fluticasone propionate/salmeterol combination on exercise in pediatric and adolescent patients with asthma.

Murray JJ, Waitkus-Edwards KR, Yancey SW - Open Respir Med J (2011)

Number of patients screened, and number of subjects enrolled, randomized, completed, and withdrawn.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3104552&req=5

Figure 1: Number of patients screened, and number of subjects enrolled, randomized, completed, and withdrawn.
Mentions: Patients screened for the study reported using ICS for at least 28 days prior to screening at a daily dosage of no more than: 264 mcg of FP metered-dose inhaler (MDI), 600 mcg of budesonide, 504 mcg of beclomethasone dipropionate, 1000 mcg of flunisolide, or 1000 mcg of triamcinolone acetonide. A total of 707 subjects were screened for the study; the majority of screen failures were due to inability to demonstrate the required drop of FEV1 following exercise challenge. A total of 231 subjects were randomized to the two study treatments: 113 to the FSC 100/50 group and 118 to FP 100. Of those randomized, 106 (94%) subjects in the FSC 100/50 group and 108 (92%) subjects in the FP 100 group completed the study (Fig. 1).

Bottom Line: A mean decrease in FEV(1) of 9.9% was observed in the FSC 100/50 group as compared with a mean decrease of 11.1% in the FP 100 group; there was no statistical difference between treatments.Both FSC 100/50 and FP 100 provided protection against an exercised-induced fall in FEV(1); but statistically significant differences we not noted.Both treatments were well-tolerated over four weeks and FSC 100/50 had an adverse event profile comparable to that observed with FP 100.

View Article: PubMed Central - PubMed

Affiliation: Internal Medicine, Meharry Medical College, Nashville, TN, USA.

ABSTRACT

Objective: This study was designed to demonstrate that four weeks of fluticasone propionate (FP) 100 micrograms (mcg) combined with salmeterol 50 mcg twice daily (BID) via DISKUS(®) resulted in protection against bronchospasm induced by activity, as measured by standardized exercise challenge testing in pediatric and adolescent subjects who required regular use of inhaled corticosteroids for the treatment of persistent asthma.

Methods: Prior to study entry, all patients reported regular use of inhaled corticosteroids (ICS). During screening all patients demonstrated ≥20% fall in FEV(1) following exercise.

Results: A total of 231 subjects aged 4 to 17 were randomized to the two study treatments: 113 to the FP/salmeterol combination group (FSC) and 118 to receive FP 100 mcg BID. Of the subjects randomized, 106 (94%) subjects in the FSC 100/50 group and 108 (92%) subjects in the FP 100 group completed the study. At the end of treatment (Week 4), both FSC and FP protected against a fall in FEV(1) following exercise in patients who at baseline experienced ≥20% fall in FEV(1) following exercise. A mean decrease in FEV(1) of 9.9% was observed in the FSC 100/50 group as compared with a mean decrease of 11.1% in the FP 100 group; there was no statistical difference between treatments.

Conclusion: Both FSC 100/50 and FP 100 provided protection against an exercised-induced fall in FEV(1); but statistically significant differences we not noted. Both treatments were well-tolerated over four weeks and FSC 100/50 had an adverse event profile comparable to that observed with FP 100.

No MeSH data available.


Related in: MedlinePlus