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Effect of long-term salmeterol therapy compared with as-needed albuterol use on airway hyperresponsiveness.
Chest. 1999 Sep; 116(3):595-602.Chest

Abstract

STUDY OBJECTIVES

To determine the effect of long-term salmeterol aerosol therapy on airway hyperresponsiveness measured by methacholine challenge.

DESIGN

Randomized, double-blind, placebo-controlled, multicenter study.

SETTING

Thirty-one clinical centers in the United States.

PATIENTS

Four hundred eight asthmatic patients > or = 12 years of age with baseline FEV1 of > or = 70% of predicted values. Patients were not using inhaled corticosteroids.

INTERVENTIONS

Twice-daily salmeterol aerosol, 42 microg, or placebo via metered-dose inhaler for 24 weeks. Backup albuterol was available.

MEASUREMENTS AND RESULTS

Pulmonary function tests were performed before, during, and after treatment. Subjects recorded asthma-related symptoms, morning and evening peak expiratory flow (PEF) levels, and use of supplemental albuterol daily on diary cards. Methacholine challenges were performed 10 to 14 h postdose at weeks 4, 12, and 24, and 3 and 7 days posttreatment. Over 24 weeks of treatment, salmeterol provided significant (p < 0.001) protection against methacholine-induced bronchoconstriction of approximately one doubling dose of methacholine when compared to placebo with no evidence for a progressive decrease in protection. A rebound increase in airway hyperresponsiveness was not observed 3 and 7 days after cessation of salmeterol therapy. Salmeterol treatment resulted in sustained improvements of 0.21 to 0.26 L in morning premedication FEV1 and an improvement of 26.2 L/min in morning PEF when compared to placebo (p < 0.001). The use of salmeterol significantly reduced combined daytime asthma symptoms by 20% when compared to placebo (p = 0.005). A total of 34 and 48 exacerbations, respectively, were reported in the Salmeterol and placebo groups, and no evidence was present for a difference in the severity of asthma exacerbations between groups. Adverse event profiles were similar for the salmeterol and placebo groups.

CONCLUSIONS

Regular long-term use of salmeterol aerosol resulted in sustained improvements in pulmonary function and asthma symptom control over the 24-week treatment period. There was no increase in bronchial hyperresponsiveness or loss of bronchoprotection at 24 weeks from that seen following 4 weeks of therapy. There was no evidence of rebound airway hyperresponsiveness after cessation of salmeterol treatment. Regular treatment with the long-acting beta-agonist salmeterol does not lead to clinical instability or vulnerability to unpredictable asthma attacks.

Authors+Show Affiliations

Johns Hopkins School of Medicine, Baltimore, MD, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

10492259

Citation

Rosenthal, R R., et al. "Effect of Long-term Salmeterol Therapy Compared With As-needed Albuterol Use On Airway Hyperresponsiveness." Chest, vol. 116, no. 3, 1999, pp. 595-602.
Rosenthal RR, Busse WW, Kemp JP, et al. Effect of long-term salmeterol therapy compared with as-needed albuterol use on airway hyperresponsiveness. Chest. 1999;116(3):595-602.
Rosenthal, R. R., Busse, W. W., Kemp, J. P., Baker, J. W., Kalberg, C., Emmett, A., & Rickard, K. A. (1999). Effect of long-term salmeterol therapy compared with as-needed albuterol use on airway hyperresponsiveness. Chest, 116(3), 595-602.
Rosenthal RR, et al. Effect of Long-term Salmeterol Therapy Compared With As-needed Albuterol Use On Airway Hyperresponsiveness. Chest. 1999;116(3):595-602. PubMed PMID: 10492259.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of long-term salmeterol therapy compared with as-needed albuterol use on airway hyperresponsiveness. AU - Rosenthal,R R, AU - Busse,W W, AU - Kemp,J P, AU - Baker,J W, AU - Kalberg,C, AU - Emmett,A, AU - Rickard,K A, PY - 1999/9/24/pubmed PY - 2000/5/20/medline PY - 1999/9/24/entrez SP - 595 EP - 602 JF - Chest JO - Chest VL - 116 IS - 3 N2 - STUDY OBJECTIVES: To determine the effect of long-term salmeterol aerosol therapy on airway hyperresponsiveness measured by methacholine challenge. DESIGN: Randomized, double-blind, placebo-controlled, multicenter study. SETTING: Thirty-one clinical centers in the United States. PATIENTS: Four hundred eight asthmatic patients > or = 12 years of age with baseline FEV1 of > or = 70% of predicted values. Patients were not using inhaled corticosteroids. INTERVENTIONS: Twice-daily salmeterol aerosol, 42 microg, or placebo via metered-dose inhaler for 24 weeks. Backup albuterol was available. MEASUREMENTS AND RESULTS: Pulmonary function tests were performed before, during, and after treatment. Subjects recorded asthma-related symptoms, morning and evening peak expiratory flow (PEF) levels, and use of supplemental albuterol daily on diary cards. Methacholine challenges were performed 10 to 14 h postdose at weeks 4, 12, and 24, and 3 and 7 days posttreatment. Over 24 weeks of treatment, salmeterol provided significant (p < 0.001) protection against methacholine-induced bronchoconstriction of approximately one doubling dose of methacholine when compared to placebo with no evidence for a progressive decrease in protection. A rebound increase in airway hyperresponsiveness was not observed 3 and 7 days after cessation of salmeterol therapy. Salmeterol treatment resulted in sustained improvements of 0.21 to 0.26 L in morning premedication FEV1 and an improvement of 26.2 L/min in morning PEF when compared to placebo (p < 0.001). The use of salmeterol significantly reduced combined daytime asthma symptoms by 20% when compared to placebo (p = 0.005). A total of 34 and 48 exacerbations, respectively, were reported in the Salmeterol and placebo groups, and no evidence was present for a difference in the severity of asthma exacerbations between groups. Adverse event profiles were similar for the salmeterol and placebo groups. CONCLUSIONS: Regular long-term use of salmeterol aerosol resulted in sustained improvements in pulmonary function and asthma symptom control over the 24-week treatment period. There was no increase in bronchial hyperresponsiveness or loss of bronchoprotection at 24 weeks from that seen following 4 weeks of therapy. There was no evidence of rebound airway hyperresponsiveness after cessation of salmeterol treatment. Regular treatment with the long-acting beta-agonist salmeterol does not lead to clinical instability or vulnerability to unpredictable asthma attacks. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/10492259/Effect_of_long_term_salmeterol_therapy_compared_with_as_needed_albuterol_use_on_airway_hyperresponsiveness_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(16)35273-4 DB - PRIME DP - Unbound Medicine ER -