title: Long-term comparison of three combinations of albuterol, theophylline, and beclomethasone in children with chronic asthma.
abstract: Three combination regimens, (1) inhaled albuterol (ALB) with oral theophylline (THEO), (2) inhaled ALB with inhaled beclomethasone dipropionate (BDP), or (3) inhaled ALB, inhaled BDP, and oral THEO, were evaluated and compared as optimal pharmacotherapy for chronic asthma in 111 children. In this double-blind, parallel-group, multicenter study, children, aged 6 to 16 years with moderately severe asthma (unstable despite daily medications), were treated with one of the combinations for 12 weeks. Patients were evaluated every 4 weeks by spirometry and serum THEO measurement. Patients kept daily symptom diaries, measured peak flow rates twice daily, and recorded adverse events. Treatment groups did not differ in disease or demographic characteristics at study entry. All three combination treatments provided and maintained significant improvement in FVC, FEV1, and FEF25%-75% volume points, and compared with that of pretreatment, with no significant differences between treatments. Throughout the 12-week treatment period, however, patients receiving BDP had lower symptom scores, fewer had more than one asthma attack, fewer required "bursts" of prednisone (p = 0.001), and fewer required rescue medication (p = 0.009). Significantly more patients receiving BDP said that they felt better than they did at the beginning of the study compared with the number of patients not receiving BDP (p = 0.002). Adverse events were similar among treatment groups.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, CA 92123.
authors.forename: E O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: H A
authors.initials: HA
authors.lastname: Orgel
authors.forename: E F
authors.initials: EF
authors.lastname: Ellis
authors.forename: H N
authors.initials: HN
authors.lastname: Eigen
authors.forename: M P
authors.initials: MP
authors.lastname: Hemstreet
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000420:Albuterol / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000453:epidemiology; D001507:Beclomethasone / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D006801:Humans; D013806:Theophylline / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D013806:Theophylline; D001507:Beclomethasone; D000420:Albuterol