Pediatric pulmonology
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Pediatric pulmonology · Jul 2000
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialFrench multicenter randomized double-blind placebo-controlled trial on nebulized amiloride in cystic fibrosis patients. The Amiloride-AFLM Collaborative Study Group.
The effect of amiloride, a sodium channel blocker, has been evaluated in a multicenter randomized double-blind placebo-controlled trial in cystic fibrosis patients more than 5-years-old (n = 137) whose forced vital capacity (FVC), forced expiratory volume in 1 sec (FEV(1)), and forced mid-expiratory flow (FEF(25-75)) were not below 50%, 50%, and 30% of reference values, respectively. Patients were randomly allocated to two parallel groups. Sixty-four patients were chronically colonized with Pseudomonas aeruginosa; they received either amiloride or placebo as a nebulized solution three times daily for 6 months. ⋯ Neither the chronically colonized, nor the noncolonized patients benefited. The confidence intervals of the differences between treatment groups indicated small differences that were most likely of no clinical significance. Complementary analyses taking into account the gender, the type of mutation, the subpopulations whose FVC and FEV(1) were below 80% of normal values at the beginning of the study, and also patients less than 10 years old, did not show any statistically or clinically significant improvements following amiloride therapy.
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Pediatric pulmonology · Mar 2000
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparative study using oral solutions of bambuterol once daily or terbutaline three times daily in 2-5-year-old children with asthma. Bambuterol Multicentre Study Group.
The aim of this study was to compare safety and efficacy of bambuterol hydrochloride (10 mg) oral solution administered once daily in the evening with terbutaline sulphate (0.075 mg/kg body weight) oral solution administered three times daily in 2-5-year-old children with asthma. There were two treatment groups: (2/3) of the patients received bambuterol and (1/3) received terbutaline. The study was double-blind, randomized, and of a parallel group design, and it lasted for 3 months after a 2-week run-in period. ⋯ In conclusion, once-daily bambuterol is as safe and effective as terbutaline given three times daily. The study also confirmed that bambuterol has a 24-hr duration of action, and therefore its once daily administration, makes it a preferred bronchodilator agent. Pediatr Pulmonol. 2000:29:194-201.
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Pediatric pulmonology · Feb 1998
Randomized Controlled Trial Multicenter Study Clinical TrialPlacebo-controlled, double-blind, randomized study of aerosolized tobramycin for early treatment of Pseudomonas aeruginosa colonization in cystic fibrosis.
In chronic Pseudomonas aeruginosa pulmonary infection of patients with cystic fibrosis (CF), antibiotic therapy generally fails to eradicate the bacterial pathogen. The mucoid bacterial phenotype, high sputum production by the host, and low airway levels of antibiotics seem to be responsible for the observed decrease in antibiotic efficacy. We hypothesized that early antibiotic treatment by inhalation in CF patients may be able to prevent or at least delay airway infection. ⋯ Using life table analysis, the time to conversion from a P. aeruginosa-positive to a P. aeruginosa-negative respiratory culture was significantly shorter in the tobramycin-treated group than in the placebo group (P < 0.05, log rank test). Lung function parameters and markers of inflammation did not change in either group during treatment. The results of this study suggest that early tobramycin inhalation may prevent and/or delay P. aeruginosa pulmonary infection in CF patients.
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Pediatric pulmonology · Apr 1997
Multicenter StudyEffect of nebulizer type and antibiotic concentration on device performance.
We compared the performance of selected ultrasonic and jet nebulizers when aerosolizing several antibiotic formulations to determine optimum combinations for delivery of a respirable antibiotic aerosol. Three ultrasonic devices were tested: the UltraNeb 99/100, the UltraAIR and the Aerosonic. The reusable jet nebulizers were the Dura ProNeb, Pari-LL and the Sidestream. ⋯ Particle size distribution was most dependent on the specific jet device, with particle size distribution less affected by a specific antibiotic or its concentration. Higher reservoir concentrations can be utilized for increasing output of respirable antibiotic aerosols by jet nebulizers. We conclude that antibiotic output is dependent upon both the nebulizing system and the reservoir concentration of antibiotic.
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Pediatric pulmonology · Aug 1996
Randomized Controlled Trial Multicenter Study Clinical TrialDose response to inhaled terbutaline powder and peak inspiratory flow through Turbuhaler in children with mild to moderate asthma.
The purpose of this study was to investigate the relative effectiveness of 0.25 mg, 0.5 mg, and 1.0 mg of terbutaline, administered via Turbuhaler, in children with mild to moderate asthma, and to register peak inspiratory flow rates through Turbuhaler (PIFTBH). Thirty-seven children in Portugal (one center) and 45 children in Sweden (one center) aged 3-10 years participated in two separate, double-blind, placebo-controlled, crossover, and randomized studies of the same design. Because of differences in other therapies for asthma and climate, combination of the two studies into one metanalysis did not appear appropriate. ⋯ In the 7-10 year group the mean PIFTBH was 72 L/min (n = 22) in Portugal, and 68 L/min (n = 22) in Sweden. We conclude that inhalation of terbutaline sulfate via Turbuhaler at a small dose of 0.25 mg resulted in good bronchodilation and was comparable to inhalations of 0.5 mg and 1.0 mg in children aged 3-10 years with mild to moderate asthma. PIFTBH were comparable to values previously recorded in healthy 6-year-old and older children and in adult asthmatic patients.