Controlled Study of Linear Growth in Asthmatic Children During Treatment With Inhaled Glucocorticosteroids

PEDIATRICS ◽  
1992 ◽  
Vol 89 (5) ◽  
pp. 839-842
Author(s):  
Ole D. Wolthers ◽  
Søren Pedersen
Keyword(s):  
Growth Velocity ◽  
Linear Growth ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Group 14 ◽  
Double Blind ◽  
Asthmatic Children ◽  
Parallel Group ◽  
Significant Difference ◽  
Inhaled Budesonide

Linear growth was investigated with weekly knemometry in a population of 43 schoolchildren with mild asthma treated with inhaled budesonide. The design was a randomized, double-blind, parallel group study with three dose groups of 200, 400, and 800 µg of budesonide per day. Each dose group received budesonide for 8 consecutive weeks. Placebo was given for either 4 weeks before or after budesonide treatment. Twelve children in the 200-µg group, 14 in the 400-µg group, and 12 in the 800-µg group completed the 12-week study period. There was no significant difference in mean growth velocity among the three dose groups during placebo treatment. Compared with placebo (growth velocity: 0.39 mm/wk), mean lower leg growth velocity was reduced with 0.26 mm/wk (P < .001, t = 5.0, df = 11; 95% confidence interval 0.14 to 0.37 mm/wk) in children treated with 800 µg of budesonide. There was no statistically significant difference in growth velocity between 200- or 400-µg budesonide treatments and placebo. These data indicate that inhaled budesonide can be safely used in doses up to 400 µg/d in schoolchildren with asthma.

CONTROLLED STUDY OF LINEAR GROWTH IN ASTHMATIC CHILDREN DURING TREATMENT WITH INHALED GLUCOCORTICOSTEROIDS

PEDIATRICS ◽  
1994 ◽  
Vol 94 (2) ◽  
pp. 270-270
Author(s):  
Christopher Randolph
Keyword(s):  
School Children ◽  
Growth Velocity ◽  
Linear Growth ◽  
Lower Leg ◽  
Mild Asthma ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference ◽  
Inhaled Budesonide ◽  
The Impact

Purpose of the Study. To determine the impact of short term inhaled budesonide on linear growth in school children with mild asthma. Study Population. Forty-three school children with mild asthma. Methods. A randomized double blind parallel group study with three dose groups of 200, 400, and 800 µg of budesonide per day administered with a 750-mL spacer (Nebuhaler). Each group received budesonide for 8 consecutive weeks. Placebo was given 4 weeks before or after budesonide. Findings. Compared with placebo, children treated with 800 µg of budesonide had a statistically significant lower leg growth velocity by 0.26 mm/week (P < .0012; t = 5.0; df = 11; 95% confidence interval, 0.14 to 0.37 mm/week). There was no statistically significant difference in the growth velocity between 200 or 400 µg of budesonide treatments and placebo. Reviewer's Comments. This study was conducted with knemometry, a method utilized in measuring the length of the lower leg with apparent high reproducibility and accuracy. Unfortunately, the correlation between growth of the lower leg and chronic growth is undear. Several steroid studies in the past have indicated that budesonide up to levels of 800 µg does not interfere with long term growth. Thus, the impact of the study is unclear at present. Clearly, a longer term study is necessary to determine the outcome of these children. Additionally, it would be important to see the impact of budesonide in chronic asthma with greater severity, which itself may interfere with growth.

scholarly journals Short-Term Outcomes of Percutaneous Trephination with a Platelet Rich Plasma Intrameniscal Injection for the Repair of Degenerative Meniscal Lesions. A Prospective, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study

2019 ◽  
Vol 20 (4) ◽  
pp. 856 ◽  
Author(s):  
Rafal Kaminski ◽  
Marta Maksymowicz-Wleklik ◽  
Krzysztof Kulinski ◽  
Katarzyna Kozar-Kaminska ◽  
Agnieszka Dabrowska-Thing ◽  
...  
Keyword(s):  
Platelet Rich Plasma ◽  
Meniscal Tear ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Non Union ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant ◽  
Patient Related Outcome

Meniscal tears are the most common orthopaedic injuries, with chronic lesions comprising up to 56% of cases. In these situations, no benefit with surgical treatment is observed. Thus, the purpose of this study was to investigate the effectiveness and safety of percutaneous intrameniscal platelet rich plasma (PRP) application to complement repair of a chronic meniscal lesion. This single centre, prospective, randomized, double-blind, placebo-controlled study included 72 patients. All subjects underwent meniscal trephination with or without concomitant PRP injection. Meniscal non-union observed in magnetic resonance arthrography or arthroscopy were considered as failures. Patient related outcome measures (PROMs) were assessed. The failure rate was significantly higher in the control group than in the PRP augmented group (70% vs. 48%, P = 0.04). Kaplan-Meyer analysis for arthroscopy-free survival showed significant reduction in the number of performed arthroscopies in the PRP augmented group. A notably higher percentage of patients treated with PRP achieved minimal clinically significant difference in visual analogue scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) symptom scores. Our trial indicates that percutaneous meniscal trephination augmented with PRP results in a significant improvement in the rate of chronic meniscal tear healing and this procedure decreases the necessity for arthroscopy in the future (8% vs. 28%, P = 0.032).

scholarly journals Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study

2021 ◽  
Author(s):  
Ravi Savarirayan ◽  
Louise Tofts ◽  
Melita Irving ◽  
William R. Wilcox ◽  
Carlos A. Bacino ◽  
...  
Keyword(s):  
Growth Velocity ◽  
Bone Growth ◽  
Growth Factor Receptor ◽  
Extension Study ◽  
Controlled Study ◽  
Open Label ◽  
Phase 3 ◽  
Double Blind ◽  
Pathogenic Variants ◽  
Growth Promoting

Abstract Purpose Achondroplasia is caused by pathogenic variants in the fibroblast growth factor receptor 3 gene that lead to impaired endochondral ossification. Vosoritide, an analog of C-type natriuretic peptide, stimulates endochondral bone growth and is in development for the treatment of achondroplasia. This phase 3 extension study was conducted to document the efficacy and safety of continuous, daily vosoritide treatment in children with achondroplasia, and the two-year results are reported. Methods After completing at least six months of a baseline observational growth study, and 52 weeks in a double-blind, placebo-controlled study, participants were eligible to continue treatment in an open-label extension study, where all participants received vosoritide at a dose of 15.0 μg/kg/day. Results In children randomized to vosoritide, annualized growth velocity increased from 4.26 cm/year at baseline to 5.39 cm/year at 52 weeks and 5.52 cm/year at week 104. In children who crossed over from placebo to vosoritide in the extension study, annualized growth velocity increased from 3.81 cm/year at week 52 to 5.43 cm/year at week 104. No new adverse effects of vosoritide were detected. Conclusion Vosoritide treatment has safe and persistent growth-promoting effects in children with achondroplasia treated daily for two years.

Inhaled Terbutaline Administered via a Spacer Fully Prevents Exercise-Induced Asthma in Young Asthmatic Subjects: A Double-Blind, Randomized, Placebo-Controlled Study

1989 ◽  
Vol 17 (6) ◽  
pp. 506-513 ◽  
Author(s):  
A.T. Dinh Xuan ◽  
C. Lebeau ◽  
R. Roche ◽  
A. Ferriere ◽  
M. Chaussain
Keyword(s):  
Room Temperature ◽  
Work Load ◽  
Cycle Ergometer ◽  
Forced Expiratory Volume ◽  
Controlled Study ◽  
Adrenergic Agonist ◽  
Double Blind ◽  
Asthmatic Children ◽  
Exercise Induced ◽  
Age Range

The effects of inhaled terbutaline, a β2-adrenergic agonist, administered via a 750-ml spacer device were studied in young asthmatic subjects with exercise-induced asthma. A double-blind, randomized, placebo-controlled study of the effects of inhaled 0.5 mg terbutaline and placebo was conducted in 10 asthmatic children (age range 6–16 years) with documented exercise-induced asthma. Forced expiratory volume in 1 s (FEV1) was measured at baseline, 15 min after inhaling terbutaline or placebo, and at intervals up to 60 min after exercising. Subjects exercised using a cycle ergometer for 5 min at a submaximal, constant work-load while breathing dry air at room temperature. Terbutaline induced bronchodilation at rest in all subject and fully prevented exercise-induced asthma in nine out of the 10 subjects; the exercise-induced fall in FEV1 was markedly reduced in the remaining subject. It is concluded that exercise-induced asthma can be inhibited by pretreatment with inhaled terbutaline, administered via a spacer, in a majority of young asthmatics.

Abstract TP146: Vagus Nerve Stimulation Paired With Rehabilitation To Improve Upper Limb Function

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jesse Dawson ◽  
Theresa J Kimberley ◽  
Gerard E Francisco ◽  
Patricia Smith ◽  
Steven C Cramer ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Human Study ◽  
Controlled Study ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Limb Function ◽  
Significant Difference

Introduction: Vagus Nerve Stimulation (VNS) paired with rehabilitation induces movement specific plasticity in rat motor cortex and improves forepaw function in a rat ischemic model compared to rehabilitation alone. A 20 subject first-in-human study in the UK indicated acceptable safety and feasibility of this approach in patients with arm weakness after stroke and showed a significant difference in favour of VNS paired with rehabilitation in the per-protocol analysis (Upper Extremity Fugl Meyer difference of 9.6 points for VNS vs. 3.0 Control; p = 0.038). We conducted a new, double-blind sham controlled study to further assess this technique. Methods: Subjects with chronic moderate to severe upper extremity hemiparesis secondary to ischemic stroke (Upper Extremity Fugl Meyer (UEFM) 20-50) were enrolled at four sites (3 US, 1 UK). After baseline assessments subjects were implanted with a vagus nerve stimulation device if all eligibility criteria were met. Following implantation, randomization was made to either paired VNS (1/2 second, 30 Hz., 0.8 mA, 100 uS stimulation with task-specific movement) or sham control (stimulation only on first 5 movements). All received the same intensive and task-specific rehabilitation and had 18 treatment sessions (2-hourly, 3 times a week for 6-weeks, approximately 50 repetitions per task and 300 to 400 repetition movements per session). Outcomes were assessed on the first and 30 th day following completion of the 6-week therapy course. Results: Sixteen patients (8 female) were implanted (8 VNS, 8 Control). Mean age (SD) was 63.2(6.9), with an average (SD) of 21.7 months (12.9) post stroke. One study related serious adverse event was reported (a wound infection that resolved with IV antibiotics). Blinded results (change in UEFM, WMFT, and UEFM responders for both groups) will be available and presented. Conclusions: A pivotal study of VNS paired with rehabilitation movements will be justified if preliminary results are confirmed.

scholarly journals Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

2018 ◽  
Vol 119 (2) ◽  
pp. 652-661 ◽  
Author(s):  
Siobhan C. Dongés ◽  
Jessica M. D’Amico ◽  
Jane E. Butler ◽  
Janet L. Taylor
Keyword(s):  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Controlled Study ◽  
Spinal Level ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Spinal Cord ◽  
Significant Difference ◽  
Antidromic Potentials ◽  
Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

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