BACKGROUND: Many physicians reduce the dose of allergen immunotherapy when patients have significant local reactions to their allergy shots, believing that these patients are at higher risk for systemic reactions. This dose reduction is made despite the fact that the World Health Organization stated in a position paper on allergen immunotherapy that local reactions are not predictive of subsequent systemic reactions.

POPULATION STUDIED: This study was conducted at a single-site Air Force allergy clinic. During the 18-month study period 12,926 allergy shots were given. No further demographic details were provided.

STUDY DESIGN AND VALIDITY: This nonconcurrent cohort study compared reaction rates to allergy shots for 9 months (October 1996 to June 1997) before an intervention with reaction rates for the 9 months (October 1997 to June 1998) after the intervention. The first group (8076 injections) had their allergy shot dose reduced if they had an immediate local reaction 20 mm or larger or if they had any localized swelling that persisted more than 12 hours. The second group (4850 injections) had no dose reduction for immediate and local reactions unless the reaction was larger than the patient’s hand (adult=8-10 cm) or caused the patient significant discomfort. In most respects the study groups can be considered similar. In fact, in many instances the same subject was probably included in both groups (because most patients receive allergy shots for several years they would have been captured in both 9-month study periods). The potential for differences in the study groups comes from selection bias and those lost to follow-up. The first 9-month period included 8076 injections, while the second 9-month period had only 4850 injections. The authors state that this is because there was difficulty getting extract during the second 9-month period, which delayed the initiation of immunotherapy for some. Because allergy shots can be grouped into 2 phases (build-up and maintenance) and the traditional teaching is that reactions are less common in patients getting maintenance shots, the second group may have had a higher proportion receiving the less-risky maintenance injections. The follow-up of both groups was by review of clinic records, of which 74% were located for the first group and 78% for the second group. Bias could be introduced if the patients who were lost to follow-up were significantly different.

OUTCOMES MEASURED: Systemic reaction rates during the 2 periods were determined. Among those with a systemic reaction, the number of times a local reaction immediately preceded the systemic reaction and the total number of previous local reactions were also determined.

RESULTS: Systemic reaction rates were not statistically different during the 2 9-month periods (0.8% before vs 1.0% after, P=.24). The number of times a local reaction preceded a systemic reaction in the first period was not significantly different from the second 9-month period (18.8% before vs 10.5% after, P=.37). The total local reaction rate for those with systemic reactions was not significantly different during the 2 study periods (7.3% before vs 4.7% after, P=.07). The calculated sensitivity for a local reaction predicting a systemic reaction at the next dose was 15% with a positive predictive value of a local reaction for a subsequent systemic reaction of 17%.

BACKGROUND: Many physicians reduce the dose of allergen immunotherapy when patients have significant local reactions to their allergy shots, believing that these patients are at higher risk for systemic reactions. This dose reduction is made despite the fact that the World Health Organization stated in a position paper on allergen immunotherapy that local reactions are not predictive of subsequent systemic reactions.

POPULATION STUDIED: This study was conducted at a single-site Air Force allergy clinic. During the 18-month study period 12,926 allergy shots were given. No further demographic details were provided.

STUDY DESIGN AND VALIDITY: This nonconcurrent cohort study compared reaction rates to allergy shots for 9 months (October 1996 to June 1997) before an intervention with reaction rates for the 9 months (October 1997 to June 1998) after the intervention. The first group (8076 injections) had their allergy shot dose reduced if they had an immediate local reaction 20 mm or larger or if they had any localized swelling that persisted more than 12 hours. The second group (4850 injections) had no dose reduction for immediate and local reactions unless the reaction was larger than the patient’s hand (adult=8-10 cm) or caused the patient significant discomfort. In most respects the study groups can be considered similar. In fact, in many instances the same subject was probably included in both groups (because most patients receive allergy shots for several years they would have been captured in both 9-month study periods). The potential for differences in the study groups comes from selection bias and those lost to follow-up. The first 9-month period included 8076 injections, while the second 9-month period had only 4850 injections. The authors state that this is because there was difficulty getting extract during the second 9-month period, which delayed the initiation of immunotherapy for some. Because allergy shots can be grouped into 2 phases (build-up and maintenance) and the traditional teaching is that reactions are less common in patients getting maintenance shots, the second group may have had a higher proportion receiving the less-risky maintenance injections. The follow-up of both groups was by review of clinic records, of which 74% were located for the first group and 78% for the second group. Bias could be introduced if the patients who were lost to follow-up were significantly different.

OUTCOMES MEASURED: Systemic reaction rates during the 2 periods were determined. Among those with a systemic reaction, the number of times a local reaction immediately preceded the systemic reaction and the total number of previous local reactions were also determined.

RESULTS: Systemic reaction rates were not statistically different during the 2 9-month periods (0.8% before vs 1.0% after, P=.24). The number of times a local reaction preceded a systemic reaction in the first period was not significantly different from the second 9-month period (18.8% before vs 10.5% after, P=.37). The total local reaction rate for those with systemic reactions was not significantly different during the 2 study periods (7.3% before vs 4.7% after, P=.07). The calculated sensitivity for a local reaction predicting a systemic reaction at the next dose was 15% with a positive predictive value of a local reaction for a subsequent systemic reaction of 17%.

BACKGROUND: Many physicians reduce the dose of allergen immunotherapy when patients have significant local reactions to their allergy shots, believing that these patients are at higher risk for systemic reactions. This dose reduction is made despite the fact that the World Health Organization stated in a position paper on allergen immunotherapy that local reactions are not predictive of subsequent systemic reactions.

POPULATION STUDIED: This study was conducted at a single-site Air Force allergy clinic. During the 18-month study period 12,926 allergy shots were given. No further demographic details were provided.

STUDY DESIGN AND VALIDITY: This nonconcurrent cohort study compared reaction rates to allergy shots for 9 months (October 1996 to June 1997) before an intervention with reaction rates for the 9 months (October 1997 to June 1998) after the intervention. The first group (8076 injections) had their allergy shot dose reduced if they had an immediate local reaction 20 mm or larger or if they had any localized swelling that persisted more than 12 hours. The second group (4850 injections) had no dose reduction for immediate and local reactions unless the reaction was larger than the patient’s hand (adult=8-10 cm) or caused the patient significant discomfort. In most respects the study groups can be considered similar. In fact, in many instances the same subject was probably included in both groups (because most patients receive allergy shots for several years they would have been captured in both 9-month study periods). The potential for differences in the study groups comes from selection bias and those lost to follow-up. The first 9-month period included 8076 injections, while the second 9-month period had only 4850 injections. The authors state that this is because there was difficulty getting extract during the second 9-month period, which delayed the initiation of immunotherapy for some. Because allergy shots can be grouped into 2 phases (build-up and maintenance) and the traditional teaching is that reactions are less common in patients getting maintenance shots, the second group may have had a higher proportion receiving the less-risky maintenance injections. The follow-up of both groups was by review of clinic records, of which 74% were located for the first group and 78% for the second group. Bias could be introduced if the patients who were lost to follow-up were significantly different.

OUTCOMES MEASURED: Systemic reaction rates during the 2 periods were determined. Among those with a systemic reaction, the number of times a local reaction immediately preceded the systemic reaction and the total number of previous local reactions were also determined.

RESULTS: Systemic reaction rates were not statistically different during the 2 9-month periods (0.8% before vs 1.0% after, P=.24). The number of times a local reaction preceded a systemic reaction in the first period was not significantly different from the second 9-month period (18.8% before vs 10.5% after, P=.37). The total local reaction rate for those with systemic reactions was not significantly different during the 2 study periods (7.3% before vs 4.7% after, P=.07). The calculated sensitivity for a local reaction predicting a systemic reaction at the next dose was 15% with a positive predictive value of a local reaction for a subsequent systemic reaction of 17%.

BACKGROUND: It is well accepted that inhaled steroids help control childhood asthma. Questions remain, however, concerning long-term use of these medicines. This study evaluated the long-term outcomes of inhaled budesonide and nedocromil.

POPULATION STUDIED: A total of 1041 children were enrolled at 8 centers. The mean age was 8.9 years. Minorities represented 30% to 35% of the participants. The children had mild to moderate asthma defined as presence of symptoms, use of an inhaled bronchodilator twice or more times weekly, or daily medication for asthma. At baseline, the patients had been hospitalized 30 times per 100 person-years, averaged 10 episode-free days per month, and had pre-bronchodilator forced expiratory volume in 1 second (FEV1) values of 93% predicted. In general, this population seems similar to that of a typical family practice, although more information would be helpful about family income, education, tobacco exposure, and the type of clinical centers involved.

STUDY DESIGN AND VALIDITY: The participants were randomized to receive 200 mg of inhaled budesonide twice daily (n=311), 8 mg of inhaled nedocromil sodium twice daily (n=312), or placebo (n=418), in a single-blind fashion. Inhaled albuterol, oral prednisone, or inhaled beclomethasone was added as needed. Follow-up visits occurred 2 and 4 months after randomization and then at 4-month intervals.

OUTCOMES MEASURED: The primary outcome was the change in FEV1 after a bronchodilator. Secondary outcomes included health services utilization such as hospitalization, symptom severity, airway responsiveness, physical growth, incidence of cataracts, and psychological development. Cost of treatment, side effects, and patient/parent satisfaction were not directly assessed.

RESULTS: The groups were similar at baseline. Children were followed for a mean of 4.3 years. Neither budesonide nor nedocromil significantly improved lung function more than placebo. Hospitalization rates decreased in all groups, but compared with placebo, patients receiving budesonide had significantly fewer hospitalizations (2.5 vs 4.4/100 person-years, or 1.9 hospitalizations prevented for 20 children treated for 5 years; P=.004), visits for urgent care (12 vs 22/100 person-years, or 10 urgent visits prevented for 20 patients treated for 5 years; P <.001), and courses of prednisone (70 courses vs 122/100 person-years, 52 courses prevented for 20 patients treated over 5 years; P <.001). Compared with the placebo group the nedocromil group had no significant difference in hospitalization rates but did have fewer urgent care visits (16 vs 22/100 person-years, or 5 fewer visits prevented for 20 patients treated over 5years; P <.02) and fewer prednisone courses (102 vs 122/100 patient years, or 20 fewer courses for 20 children treated for 5 years; P <.01) versus placebo. Children taking budesonide but not nedocromil recorded significantly fewer symptoms, less frequent use of albuterol, and more episode-free days than those receiving just placebo. Increase in height was significantly less for the budesonide group (22.7 cm vs 23.8 cm, P=.005), although there was no significant difference in overall growth velocity, Tanner stage, or projected final height among the 3 groups at the end of the treatment period.

BACKGROUND: It is well accepted that inhaled steroids help control childhood asthma. Questions remain, however, concerning long-term use of these medicines. This study evaluated the long-term outcomes of inhaled budesonide and nedocromil.

POPULATION STUDIED: A total of 1041 children were enrolled at 8 centers. The mean age was 8.9 years. Minorities represented 30% to 35% of the participants. The children had mild to moderate asthma defined as presence of symptoms, use of an inhaled bronchodilator twice or more times weekly, or daily medication for asthma. At baseline, the patients had been hospitalized 30 times per 100 person-years, averaged 10 episode-free days per month, and had pre-bronchodilator forced expiratory volume in 1 second (FEV1) values of 93% predicted. In general, this population seems similar to that of a typical family practice, although more information would be helpful about family income, education, tobacco exposure, and the type of clinical centers involved.

STUDY DESIGN AND VALIDITY: The participants were randomized to receive 200 mg of inhaled budesonide twice daily (n=311), 8 mg of inhaled nedocromil sodium twice daily (n=312), or placebo (n=418), in a single-blind fashion. Inhaled albuterol, oral prednisone, or inhaled beclomethasone was added as needed. Follow-up visits occurred 2 and 4 months after randomization and then at 4-month intervals.

OUTCOMES MEASURED: The primary outcome was the change in FEV1 after a bronchodilator. Secondary outcomes included health services utilization such as hospitalization, symptom severity, airway responsiveness, physical growth, incidence of cataracts, and psychological development. Cost of treatment, side effects, and patient/parent satisfaction were not directly assessed.

RESULTS: The groups were similar at baseline. Children were followed for a mean of 4.3 years. Neither budesonide nor nedocromil significantly improved lung function more than placebo. Hospitalization rates decreased in all groups, but compared with placebo, patients receiving budesonide had significantly fewer hospitalizations (2.5 vs 4.4/100 person-years, or 1.9 hospitalizations prevented for 20 children treated for 5 years; P=.004), visits for urgent care (12 vs 22/100 person-years, or 10 urgent visits prevented for 20 patients treated for 5 years; P <.001), and courses of prednisone (70 courses vs 122/100 person-years, 52 courses prevented for 20 patients treated over 5 years; P <.001). Compared with the placebo group the nedocromil group had no significant difference in hospitalization rates but did have fewer urgent care visits (16 vs 22/100 person-years, or 5 fewer visits prevented for 20 patients treated over 5years; P <.02) and fewer prednisone courses (102 vs 122/100 patient years, or 20 fewer courses for 20 children treated for 5 years; P <.01) versus placebo. Children taking budesonide but not nedocromil recorded significantly fewer symptoms, less frequent use of albuterol, and more episode-free days than those receiving just placebo. Increase in height was significantly less for the budesonide group (22.7 cm vs 23.8 cm, P=.005), although there was no significant difference in overall growth velocity, Tanner stage, or projected final height among the 3 groups at the end of the treatment period.

BACKGROUND: It is well accepted that inhaled steroids help control childhood asthma. Questions remain, however, concerning long-term use of these medicines. This study evaluated the long-term outcomes of inhaled budesonide and nedocromil.

POPULATION STUDIED: A total of 1041 children were enrolled at 8 centers. The mean age was 8.9 years. Minorities represented 30% to 35% of the participants. The children had mild to moderate asthma defined as presence of symptoms, use of an inhaled bronchodilator twice or more times weekly, or daily medication for asthma. At baseline, the patients had been hospitalized 30 times per 100 person-years, averaged 10 episode-free days per month, and had pre-bronchodilator forced expiratory volume in 1 second (FEV1) values of 93% predicted. In general, this population seems similar to that of a typical family practice, although more information would be helpful about family income, education, tobacco exposure, and the type of clinical centers involved.

STUDY DESIGN AND VALIDITY: The participants were randomized to receive 200 mg of inhaled budesonide twice daily (n=311), 8 mg of inhaled nedocromil sodium twice daily (n=312), or placebo (n=418), in a single-blind fashion. Inhaled albuterol, oral prednisone, or inhaled beclomethasone was added as needed. Follow-up visits occurred 2 and 4 months after randomization and then at 4-month intervals.

OUTCOMES MEASURED: The primary outcome was the change in FEV1 after a bronchodilator. Secondary outcomes included health services utilization such as hospitalization, symptom severity, airway responsiveness, physical growth, incidence of cataracts, and psychological development. Cost of treatment, side effects, and patient/parent satisfaction were not directly assessed.

RESULTS: The groups were similar at baseline. Children were followed for a mean of 4.3 years. Neither budesonide nor nedocromil significantly improved lung function more than placebo. Hospitalization rates decreased in all groups, but compared with placebo, patients receiving budesonide had significantly fewer hospitalizations (2.5 vs 4.4/100 person-years, or 1.9 hospitalizations prevented for 20 children treated for 5 years; P=.004), visits for urgent care (12 vs 22/100 person-years, or 10 urgent visits prevented for 20 patients treated for 5 years; P <.001), and courses of prednisone (70 courses vs 122/100 person-years, 52 courses prevented for 20 patients treated over 5 years; P <.001). Compared with the placebo group the nedocromil group had no significant difference in hospitalization rates but did have fewer urgent care visits (16 vs 22/100 person-years, or 5 fewer visits prevented for 20 patients treated over 5years; P <.02) and fewer prednisone courses (102 vs 122/100 patient years, or 20 fewer courses for 20 children treated for 5 years; P <.01) versus placebo. Children taking budesonide but not nedocromil recorded significantly fewer symptoms, less frequent use of albuterol, and more episode-free days than those receiving just placebo. Increase in height was significantly less for the budesonide group (22.7 cm vs 23.8 cm, P=.005), although there was no significant difference in overall growth velocity, Tanner stage, or projected final height among the 3 groups at the end of the treatment period.