The EDICT study.
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Anti-Asthmatic Agents↗
Biomedical subjects
C Hultquist
Publications and source records attributed to C Hultquist.
Low-dose budesonide improves exercise-induced bronchospasm in schoolchildren.
The aim of this study was to compare the clinical efficacy of low-dose inhaled budesonide (once or twice daily) and placebo, administered via Turbuhaler, on exercise-induced bronchoconstriction (EIB) in children with mild asthma. Fifty-seven steroid-naive children (7-16 years old; 41 boys, 16 girls) with EIB participated in this sub-population study according to the following inclusion criterion: a maximum fall in forced expiratory volume in 1 s (FEV1) > or = 10% after a standardized treadmill test. Mean baseline FEV1 was 100.3% of predicted, and mean maximum fall in FEV1 after the standardized exercise test was 22%. The study was a double-blind, randomized, parallel-group design. After 2 weeks of run-in, the children received inhaled budesonide 100 microg or 200 microg once daily in the morning, 100 microg twice daily, or placebo, for 12 weeks. After 12 weeks of treatment, the fall in FEV1 after the exercise test was significantly less in all three budesonide groups (7.2-7.8%) vs. placebo (16.7%). Daytime symptom scores were significantly lower in all three budesonide groups compared with placebo (p <0.02). The three budesonide groups did not differ significantly, and no significant change in lung function was found in any group. Therefore children with mild asthma, but with significant EIB, improved their exercise tolerance and symptom control after 3 months of treatment with a low dose of inhaled budesonide given once or twice daily.
Administration, Inhalation↗
Comparison of inhaled beclomethasone and budesonide. Study was inadequate.
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Administration, Topical↗
Clinical efficacy and safety of budesonide Turbuhaler in adults.
In two studies comparing budesonide delivered by Turbuhaler with budesonide delivered by pressurized metered dose inhaler (pMDI), a significantly higher morning peak expiratory flow (PEF), and a patient preference in favor of budesonide by Turbuhaler was found. Less cough was also noted. In a third study no difference was found between the two formulations. However, a meta-analysis of the three studies demonstrated a significant difference in favor of budesonide by Turbuhaler for forced expiratory volume in one second (FEV1) and morning PEF. These findings are supported by data on lung deposition showing the Turbuhaler to be twice as efficient as a pMDI. At the same time, the availability of budesonide from the gastrointestinal tract is reduced. Thus, a more beneficial ratio arises between local lung delivery and systemic availability. Inhaled glucocorticosteroids are now recommended for mild asthma. Thus once daily treatment with 400mug budesonide by Turbuhaler has been studied in two trials; a comparison with 200mug twice daily was also made. In both studies morning/evening PEF increased significantly over placebo and no difference was demonstrated between once- and twice-daily treatments. A study to determine the effect of placebo and 200mug twice daily and 400mug once daily of budesonide by Turbuhaler on 24-h plasma and urinary cortisol demonstrated no difference between the treatment regimens. Budesonide by Turbuhaler is at least as effective as budesonide by pMDI. When patients are switched to budesonide by Turbuhaler an attempt should be made to reduce the dose.(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
Gm allotypes as indicators of non-atopic and atopic bronchial asthma.
69 Caucasian children, 34 with non-atopic and 35 with atopic bronchial asthma, demonstrated different, Gm-associated IgG antibody responsiveness. The non-atopic bronchial asthma group showed a preponderance of the Gm(a,'',g) haplotype, while the atopic study group showed a preponderance of the haplotype with the alternative allotypes on all IgG subclass loci, namely Gm(f,n,b). Patients with non-atopic bronchial asthma showed a significantly increased frequency of the phenotypes containing the Gm(a,'',g) haplotype, namely the Gm(a,'',g/a,'',g) and Gm(a,'',g/f,'',b), and an increased number of individuals were homozygous G2m('','') on the IgG2 locus. The 2 asthma groups showed different characteristic IgG subclass patterns, the non-atopic group with significantly decreased IgG2 and IgG3, especially those of the Gm(a,'',g/a,'',g) phenotype, and the atopic group with significantly increased IgG1 and IgG4, especially those of the Gm(f,n,b/f,n,b) phenotype. The characteristic IgG subclass patterns originate from the different Gm phenotypes found in the 2 groups. The results emphasize the presence of qualitatively and quantitatively different IgG molecules in non-atopic and atopic bronchial asthma patients and show the interest in studying IgG genes and IgG molecules as markers of pathogenesis. G2m('','') homozygosity is a new important marker of non-atopic bronchial asthma.
Adolescent↗
Effect of inhaled terbutaline sulphate in relation to its deposition in the lungs.
We studied the effects of inhaled terbutaline on FEV1 and gas exchange, and the pattern of deposition within the lungs. To document this and to estimate the dose of terbutaline administered to the lungs, [99mTc]DTPA was added to nebulised terbutaline solution. The aerosol was deposited preferentially in large or small airways by using aerosols with different particle mass median diameters (1.5 and 4.8 microns) and different inhalation flow rates (0.25 and 1.0 l/s). The patients inhaled placebo and then three increasing doses of terbutaline (0.006, 0.02 and 0.08 mg to the lungs). Finally, 2 mg terbutaline was inhaled from a metered dose inhaler via a spacer. After each inhalation FEV1, PaO2 and PaCO2 was measured. The inhalation of small particles at a low flow resulted in a fairly uniform lung deposition, while larger particles at a higher flow resulted in heavy central deposition. Penetration index for small and large particles were 1.3 +/- 0.2 and 0.8 +/- 0.3 (P less than 0.001), respectively. In both groups FEV1 increased similarly with each dose, and at 0.02 and 0.08 mg the increase was significant (P less than 0.01). After eight metered doses of terbutaline sulphate (0.25 mg per dose) inhaled via a spacer, there was a further increase in FEV1 (P less than 0.001). Gas exchange did not differ between the two groups but if they were combined the DA-aO2 was significantly lower after metered doses than control (P less than 0.05). Thus, it appears that the site of deposition is not important for the bronchodilator effect of terbutaline, and gas exchange tended to improve with both modes of administration.
Adult↗
A double-blind comparison between a new multidose powder inhaler (Turbuhaler) and metered dose inhaler in children with asthma.
Turbuhaler is a ready-loaded multiple dose inhaler which does not require co-ordination between release of dose and inhalation. 57 children with asthma participated in this clinical trial to compare the clinical effect and acceptance of terbutaline sulphate via Turbuhaler with that of metered dose inhaler (MDI). The trial consisted of two parts. In the first part of the study, which made use of a double-blind cross-over design, the clinical effect and number of treatment occasions with Turbuhaler were compared with those of MDI. In the second part, which was open, all patients were treated with Turbuhaler for 2 weeks. At the end of this period the patients were asked to make a subjective assessment of effect and to state their preference. There was no difference in clinical effect and number of treatment occasions between Turbuhaler and MDI. A majority of the patients thought Turbuhaler had the best effect and was easy to use.
Adolescent↗
Pharmacokinetics of intravenous terbutaline in asthmatic children.
Seven asthmatic children were given terbutaline intravenously. The intact drug was measured in plasma and urine, and its conjugates were measured in urine. The decreasing plasma concentrations of terbutaline did not attain a terminal slope until 8-12 h after dosing. This was most likely due to different kinetics of the enantiomers. The terminal half-life was 8.8-15.8 h. Body clearance was 2.73-5.44 ml/min/kg, two-thirds of which were of renal origin. The volume of distribution (Vss) was 1.28-1.83 l/kg. The disposition pharmacokinetics of terbutaline do not rationalize a higher dose per kg body weight in children than in adults.
Asthma↗
Kinetics of terbutaline in asthmatic children.
Seven asthmatic children (8-12 years) were given terbutaline sulphate intravenously (5.5 micrograms/kg) and orally (50 micrograms/kg) one week apart. Unchanged terbutaline was measured in plasma and urine. In urine, conjugates were also assayed. The intravenous plasma concentration-time curve declined in a multiexponential manner. The terminal half-life ranged from 8.8 to 15.8 (mean 12.1) h. Body clearance (mean +/- SD) was 3.76 +/- 0.86, renal clearance 2.42 +/- 0.49 mL/min/kg. The volume of distribution at steady state was 1.57 +/- 0.19 L/kg. The extrapolated recovery of intact terbutaline in urine was 65.4 +/- 6.5% of the dose and the total recovery 80.8 +/- 8.4%. After oral administration, the recovery of intact terbutaline in urine was 6.2 +/- 1.1%. Absorption was on average 33%, but because of a mean first-pass elimination of 70%, bioavailability was 9.5 +/- 2.4%. It seems that children as a group have shorter terminal half-lives than adults and slightly higher weight-corrected clearances.
Administration, Oral↗
[Pinprick testing of children].
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Asthma↗
[Pinprick testing of adults].
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Adolescent↗
Reflex sympathetic dystrophy in two young females.
Reflex sympathetic dystrophy in paediatric patients is a rarely recognized pain syndrome probably of neurovascular origin. The manifectations in two young females consisted of disabling pain and localized hyperesthesia in lower extremities without evident trauma. Sympathetic block followed by active mobilization and, in the patient with atrophic changes, lumbar sympathectomy, resulted in complete recovery. Reflex sympathetic dystrophy should be considered in the differential diagnosis of pain and tenderness in an extremity.
Adolescent↗