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Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol.
Ann Allergy Asthma Immunol 1999; 82(2):205-11AA

Abstract

BACKGROUND

Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pretreatment with the beta2 (beta 2)-adrenoreceptor agonist albuterol is effective for preventing EIB, but is recognized as providing only short-term (2 to 3 hour) protection.

OBJECTIVE

To evaluate the 12-hour efficacy and safety of single doses of 25 micrograms and 50 micrograms of salmeterol powder administered via Diskus inhaler versus albuterol aerosol via pressurized metered-dose inhaler and placebo in preventing EIB in asthmatic children.

METHODS

A randomized, double-blind, placebo-controlled, double-dummy, single-dose, four-way crossover study was conducted in pediatric patients (4 to 11 years of age) demonstrating EIB and mild-to-moderate asthma. Serial forced expiratory volume in 1 second (FEV1) was measured before and after standard treadmill exercise at hour 1, hour 6, and hour 12 after administration of 25 micrograms or 50 micrograms salmeterol powder, 180 micrograms albuterol aerosol, or placebo. Adverse events were recorded.

RESULTS

After completion of the hour 1 exercise challenge, mean minimum % predicted FEV1 was significantly higher following albuterol (91.3%) than for placebo (75.3%) and for both dosages of salmeterol (86.9% and 85.8% for salmeterol 25 micrograms and 50 micrograms, respectively; P < or = .026). After completion of both the hour 6 and hour 12 exercise challenges, the 50-microgram salmeterol treatment produced a significantly higher mean minimum percent of predicted FEV1 (90.6% and 87.3% predicted, respectively) than the mean minimum percent of predicted FEV1 for placebo or albuterol (73.8% to 78.4% of predicted; P < or = .041). At hour 6, the 25-microgram salmeterol treatment was not significantly different from albuterol or placebo. At hour 12, the 25-microgram salmeterol treatment mean minimum percent of predicted was significantly higher than albuterol (87.9% versus 73.8% of predicted; P = .006) and there was also a trend toward significance over placebo (76.9% predicted; P = .056). At all exercise periods, no statistically significant differences in spirometry values were observed between the two salmeterol treatment groups. Safety profiles were similar among treatments, including placebo. No drug-related adverse events or withdrawals due to adverse events occurred. Changes in laboratory values, vital signs, 12-lead ECGs, and physical examinations were unremarkable.

CONCLUSIONS

A single 50-microgram dose of salmeterol powder provided effective and safe protection against EIB for at least 12 hours in asthmatic children and provided a significantly more prolonged effect than albuterol aerosol (180 micrograms).

Authors+Show Affiliations

Nemours Children's Clinic, Jacksonville, Florida, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10071526

Citation

Blake, K, et al. "Prevention of Exercise-induced Bronchospasm in Pediatric Asthma Patients: a Comparison of Salmeterol Powder With Albuterol." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 82, no. 2, 1999, pp. 205-11.
Blake K, Pearlman DS, Scott C, et al. Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol. Ann Allergy Asthma Immunol. 1999;82(2):205-11.
Blake, K., Pearlman, D. S., Scott, C., Wang, Y., Stahl, E., & Arledge, T. (1999). Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 82(2), pp. 205-11.
Blake K, et al. Prevention of Exercise-induced Bronchospasm in Pediatric Asthma Patients: a Comparison of Salmeterol Powder With Albuterol. Ann Allergy Asthma Immunol. 1999;82(2):205-11. PubMed PMID: 10071526.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol. AU - Blake,K, AU - Pearlman,D S, AU - Scott,C, AU - Wang,Y, AU - Stahl,E, AU - Arledge,T, PY - 1999/3/11/pubmed PY - 1999/3/11/medline PY - 1999/3/11/entrez SP - 205 EP - 11 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 82 IS - 2 N2 - BACKGROUND: Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pretreatment with the beta2 (beta 2)-adrenoreceptor agonist albuterol is effective for preventing EIB, but is recognized as providing only short-term (2 to 3 hour) protection. OBJECTIVE: To evaluate the 12-hour efficacy and safety of single doses of 25 micrograms and 50 micrograms of salmeterol powder administered via Diskus inhaler versus albuterol aerosol via pressurized metered-dose inhaler and placebo in preventing EIB in asthmatic children. METHODS: A randomized, double-blind, placebo-controlled, double-dummy, single-dose, four-way crossover study was conducted in pediatric patients (4 to 11 years of age) demonstrating EIB and mild-to-moderate asthma. Serial forced expiratory volume in 1 second (FEV1) was measured before and after standard treadmill exercise at hour 1, hour 6, and hour 12 after administration of 25 micrograms or 50 micrograms salmeterol powder, 180 micrograms albuterol aerosol, or placebo. Adverse events were recorded. RESULTS: After completion of the hour 1 exercise challenge, mean minimum % predicted FEV1 was significantly higher following albuterol (91.3%) than for placebo (75.3%) and for both dosages of salmeterol (86.9% and 85.8% for salmeterol 25 micrograms and 50 micrograms, respectively; P < or = .026). After completion of both the hour 6 and hour 12 exercise challenges, the 50-microgram salmeterol treatment produced a significantly higher mean minimum percent of predicted FEV1 (90.6% and 87.3% predicted, respectively) than the mean minimum percent of predicted FEV1 for placebo or albuterol (73.8% to 78.4% of predicted; P < or = .041). At hour 6, the 25-microgram salmeterol treatment was not significantly different from albuterol or placebo. At hour 12, the 25-microgram salmeterol treatment mean minimum percent of predicted was significantly higher than albuterol (87.9% versus 73.8% of predicted; P = .006) and there was also a trend toward significance over placebo (76.9% predicted; P = .056). At all exercise periods, no statistically significant differences in spirometry values were observed between the two salmeterol treatment groups. Safety profiles were similar among treatments, including placebo. No drug-related adverse events or withdrawals due to adverse events occurred. Changes in laboratory values, vital signs, 12-lead ECGs, and physical examinations were unremarkable. CONCLUSIONS: A single 50-microgram dose of salmeterol powder provided effective and safe protection against EIB for at least 12 hours in asthmatic children and provided a significantly more prolonged effect than albuterol aerosol (180 micrograms). SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/10071526/Prevention_of_exercise_induced_bronchospasm_in_pediatric_asthma_patients:_a_comparison_of_salmeterol_powder_with_albuterol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)62598-7 DB - PRIME DP - Unbound Medicine ER -