Effectiveness of Terbutaline and Theophylline Alone and in Combination in Exercise-Induced Bronchospasm

PEDIATRICS ◽  
1981 ◽  
Vol 67 (4) ◽  
pp. 508-513
Author(s):  
Gail G. Shapiro ◽  
Joseph J. McPhillips ◽  
Kevin Smith ◽  
Clifton T. Furukawa ◽  
William E. Pierson ◽  
...  
Keyword(s):  
Drug Administration ◽  
Study Drug ◽  
Forced Expiratory Volume ◽  
Exercise Tests ◽  
Double Blind ◽  
Study Drug Administration ◽  
Before And After ◽  
Forced Expiratory Flow ◽  
Exercise Induced ◽  
Better Than

Theophylline and terbutaline, alone and in combination, were evaluated for effectiveness in treating exercise-induced bronchospasm (EIB) when used at doses that should be tolerated by adolescents taking them intermittently: theophylline, 250 mg (fast release), and terbutaline, 2.5 mg. Twenty-one subjects, 12 to 19 years of age, with EIB performed standardized exercise tests on four separate days and received either theophylline, terbutaline, the combination, or placebo in a prerandomized double-blind manner prior to exercise. Exercise tests were performed two and five hours after each study drug administration. Blood samples were drawn before and again two and five hours after drug administration for theophylline level. Pulmonary function [forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and forced expiratory flow rate (FEF25% to 75%)] was recorded before and after exercise. All of the active treatments were better than placebo in diminishing EIB. The combination was statistically better than terbutaline or theophylline alone. The effect of theophylline was not significantly different from that of terbutaline. The combination induced significantly more tremor than either agent individually. Either drug alone or the two in combination is effective for diminishing EIB. Although the combination may have additive properties for some patients, the increased incidence of tremor may diminish its appeal. Either drug alone or in combination is effective in decreasing EIB for at least five hours, which makes them practical choices for treatment of school-aged children.

Acute and Chronic Theophylline Therapy in Exercise-Induced Bronchospasm

PEDIATRICS ◽  
1977 ◽  
Vol 60 (6) ◽  
pp. 845-849
Author(s):  
C. Warren Bierman ◽  
Gail G. Shapiro ◽  
William E. Pierson ◽  
Carol S. Dorsett
Keyword(s):  
Exercise Test ◽  
Vital Capacity ◽  
Forced Expiratory Volume ◽  
Repeated Testing ◽  
Before And After ◽  
Control Asthma ◽  
Forced Expiratory Flow ◽  
Treatment Changes ◽  
Expiratory Flow ◽  
Exercise Induced

This study examined the effectiveness of theophylline therapy in modifying exercise-induced bronchospasm (EIB) in children with perennial asthma and evaluated whether tolerance to theophylline developed with prolonged use. Twenty-one children between 7 and 16 years of age were studied by a standardized treadmill exercise test carried out before administration of theophylline, 90 minutes after administration of theophylline, and again after three weeks of round-the-clock theophylline treatment. Changes in forced expiratory volume at one second, forced expiratory flow between 25% and 75% of vital capacity, and peak expiratory flow rate were measured before and after each exercise test. Theophylline inhibited EIB in 20 of 21 subjects. There was considerable intersubject variation in the response to theophylline, however, ranging from complete inhibition in five subjects to no inhibition at all in one subject, even though theophylline controlled perennial asthma in all subjects, and all but one had theophylline levels between 10 and 22 µg/ml when tested. On repeated testing after three weeks of therapy, no tolerance developed to theophylline. These findings suggest that EIB and perennial asthma may result from different causes and that theophylline's ability to control asthma will not predict its effect on EIB. Subjects who have severe EIB should be retested after theophylline pretreatment to evaluate the effectiveness of therapy.

Intravenous Ondansetron in Established Postoperative Emesis in Children

1996 ◽  
Vol 85 (2) ◽  
pp. 270-276 ◽  
Author(s):  
Samia Khalil ◽  
Alexander Rodarte ◽  
Craig B. Weldon ◽  
Michael Weinstein ◽  
Zvi Grunwald ◽  
...  
Keyword(s):  
Nitrous Oxide ◽  
Placebo Group ◽  
Median Time ◽  
Drug Administration ◽  
Rescue Medication ◽  
Hospital Admissions ◽  
Outpatient Surgery ◽  
Study Drug ◽  
Double Blind ◽  
Study Drug Administration

Background In pediatric postsurgical patients, postoperative vomiting is a common occurrence that can delay recovery and result in unplanned hospital admissions after outpatient surgery. This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of ondansetron in the control of established postoperative emesis in outpatients aged 2-12 yr. Methods Screened for the study were 2,720 ASA physical status 1-3 children undergoing outpatient surgery during general anesthesia, which included nitrous oxide. Children experiencing two emetic episodes within 2 h of discontinuation of nitrous oxide were given intravenous ondansetron (n = 192; 0.1 mg/kg for children weighing < or = 40 kg; 4 mg for children weighing > 40 kg) or placebo (n = 183). Results The proportion of children with no emetic episodes and no use of rescue medication was significantly greater (P < 0.001) in the ondansetron group compared with placebo for both 2- and 24-h periods after study drug administration (78% of the ondansetron group and 34% of the placebo group for 2 h; 53% of the ondansetron group and 17% of the placebo group for 24 h). Among patients with at least one emetic episode or with rescue medication use, the median time to onset of emesis or rescue was 127 min in the ondansetron group compared with 58 min in the placebo group (P < 0.001). The median time from study drug administration until discharge was significantly shorter (P < 0.01) in the ondansetron group (153 min, range 44-593 min) compared with the placebo group (173 min, range 82-622 min). The incidence of potentially drug-related adverse events was similar in the ondansetron (3% of patients) and the placebo (4% of patients) groups. Conclusion A single dose of ondansetron (0.1 mg/kg up to 4 mg) is effective and well tolerated in the prevention of further episodes of postoperative emesis in children after outpatient surgery. Administration of ondansetron also may result in a shorter time to discharge.

The Effect of Cromolyn Sodium on Exercise-Induced Bronchospasm Using a Free Running System

PEDIATRICS ◽  
1975 ◽  
Vol 56 (5s) ◽  
pp. 923-926
Author(s):  
Gall G. Shapiro ◽  
William E. Pierson ◽  
C. Warren Blerman
Keyword(s):  
Pulmonary Function Tests ◽  
Airway Disease ◽  
Forced Expiratory Volume ◽  
Double Blind ◽  
Beneficial Effects ◽  
Running System ◽  
Volume Curve ◽  
Before And After ◽  
Free Running ◽  
Exercise Induced

This study was designed to assess the effectiveness of comolyn sodium in modifying exercise-induced bronchospasm (EIB). Twenty children and adolescents with EIB were given either cromolyn or placebo in a prerandomized double-blind fashion. They then performed a free running maneuver. Pulmonary function tests were obtained before and after this exercise. Patients returned one week later to repeat the same procedure. This time subjects took placebo if they had previously taken cromolyn and vice versa. Significant beneficial effects of cromolyn were noted in forced vital capacity and forced expiratory volume in one second measurements but not in forced expiratory flow between 25% and 75% of the flow-volume curve) (FEF 25%-75%). This suggests that larger airway disease is preferentially helped by cromolyn when subjects are stressed maximally as with a free running system. Subjects who received placebo on study day 1 and cromolyn on study day 2 showed the most striking benefit from cromolyn. This may be related to the better baseline status of subjects on day 2 as well as to familiarity with the procedure and medication.

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 11817: The Effect of Time to Treatment With Antiarrhythmic Drugs on Return of Spontaneous Circulation in Shock Refractory Out-of-Hospital Cardiac Arrest: A Secondary Analysis of the ALPS Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Mahbod Rahimi ◽  
Paul Dorian ◽  
Sheldon Cheskes ◽  
Gerald Lebovic ◽  
Steve Lin
Keyword(s):  
Cardiac Arrest ◽  
Drug Administration ◽  
Controlled Trial ◽  
Group Versus ◽  
Study Drug ◽  
Spontaneous Circulation ◽  
Study Drug Administration ◽  
Time To Treatment ◽  
Return Of Spontaneous Circulation ◽  
Hospital Cardiac Arrest

Purpose: The effects of amiodarone and lidocaine on the return of spontaneous circulation (ROSC), relative to time to treatment in out of hospital cardiac arrest (OHCA) patients is unknown. We conducted a post-hoc analysis of the Resuscitation Outcomes Consortium Amiodarone, Lidocaine, Placebo (ROC ALPS) randomized trial examining the association of time to treatment with ROSC at emergency department (ED) arrival. Method: In the ROC ALPS trial, adults with non-traumatic OHCA with initial VF/pVT after ≥ 1 shock were randomized to receive amiodarone, lidocaine or placebo. We used logistic regression to examine the association of time to treatment (911 call to study drug administration interval) with ROSC at ED arrival. Results: Overall, 1112 (36.7%) patients had ROSC at ED arrival. Time to treatment data were available for 2994 (99%) of the patients. The proportion of patients with ROSC at ED arrival decreased as time to drug administration increased, in amiodarone (OR 0.92, 95% CI 0.90-0.94 per min increase), lidocaine (OR 0.95, 95% CI: 0.93-0.96) and placebo (OR 0.95, 95% CI: 0.93-0.96) arms. The odds of ROSC at ED in the amiodarone group (versus placebo) changed in relation to the time of drug administration (OR 0.96, 95% CI: 0.93-0.99). With short times to drug administration, ROSC was higher in amiodarone versus placebo recipients, whereas ROSC was higher with placebo at later times. Comparing lidocaine to placebo, ROSC rate increased at all times (OR 1.29, 95% CI: 1.07-1.59); there was no time to drug administration effect (OR 1.00, 95% CI: 0.97-1.03). Among all patients, survival at hospital discharge was 21.0%, 24.4%, and 23.7% for placebo, amiodarone and lidocaine respectively. Conclusion: Amiodarone’s efficacy in restoring ROSC declined with longer duration of arrest, potentially due to its adverse hemodynamic effects. Overall, amiodarone and lidocaine had similar effects on mortality; in this study, ROSC at ED arrival trend did not reflect the overall survival rate

Comparison of the Effects of Inhaled SCH 1000 and Fenoterol on Exercise-Induced Bronchospasm in Children

PEDIATRICS ◽  
1980 ◽  
Vol 66 (1) ◽  
pp. 109-114
Author(s):  
R. Yeung ◽  
G. M. Nolan ◽  
H. Levison
Keyword(s):  
Side Effects ◽  
Pulmonary Function ◽  
Controlled Study ◽  
Anticholinergic Drugs ◽  
Base Line ◽  
Anticholinergic Agent ◽  
Asthmatic Children ◽  
Before And After ◽  
Exercise Induced ◽  
Better Than

The effect of 40 µg of SCH 1000 (ipratropium bromide, an anticholinergic agent) on bronchodilation and suppression of exercise-induced bronchospasm (EIB) was compared with 400 µg of fenoterol and a placebo in a single-blind controlled study. Twenty-seven randomly selected asthmatic children performed a standardized treadmill exercise challenge and the 17 children who were shown to have EIB continued in the study. Pulmonary function was evaluated before and after drug administration and exercise. When individual results were analyzed and grouped according to the responsiveness of EIB to the drugs, two patterns emerged: (1) the EIB was more severe in those (6/17) children who did not respond to either drug than in the rest of the children; (2) the resting pulmonary function was significantly better in the children (4/17) who responded to both drugs than in those (7/17) who responded to fenoterol alone. In conclusion SCH 1000 was shown to be an effective bronchodilator comparable to, but no better than, fenoterol. It had minimal side effects. As an EIB inhibitor it depended on relatively normal base line pulmonary function and only a moderate deterioration following exercise, whereas fenoterol depended on the exercise response alone. Although anticholinergic drugs are not very extensively used, SCH 1000 may be useful in some patients where the β2 adrenergic drugs cause significant side effects or are contraindicated.

scholarly journals The impact of a heat and moisture exchange mask on respiratory symptoms and airway response to exercise in asthma

2020 ◽  
Vol 6 (2) ◽  
pp. 00271-2019
Author(s):  
Anna R. Jackson ◽  
J.H. Hull ◽  
James G. Hopker ◽  
Hannah Fletcher ◽  
William Gowers ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Respiratory Symptoms ◽  
Face Mask ◽  
Forced Expiratory Volume ◽  
Peak Power Output ◽  
Post Exercise ◽  
Before And After ◽  
Exercise Induced ◽  
Heat And Moisture ◽  
The Impact

Respiratory symptoms, including cough, are prevalent in individuals with asthma when exercising. This study investigates whether a heat and moisture exchanger (HME) face mask is effective in modulating exercise-induced bronchoconstriction (EIB) and post-exercise cough in a cold, dry environment in individuals with asthma.Twenty-six participants diagnosed with asthma (20 males, 6 females) completed three cycling exercise challenges at 8°C and 24% relative humidity in a randomised order. Participants wore either an HME mask (MASK), sham mask (SHAM), or no mask (CONT). Following a 3-min warm-up, participants completed 6-min cycling at 80% peak power output. Before and after exercise, maximal flow-volume loops were recorded. Post-exercise cough was monitored with a Leicester Cough Monitor (LCM) for 24 h. Results were analysed using repeated-measures ANOVA and Friedman's tests and data were presented as the mean±sd or median (interquartile range (IQR)).Eleven participants failed to demonstrate EIB (i.e. >10% fall in forced expiratory volume in 1 s after exercise) and were removed from analysis. The percentage fall in forced expiratory volume in 1 s following exercise in CONT was greater than MASK (MASK: −6% (7%), SHAM: −11% (11%), CONT: −13% (9%); p<0.01). No difference was found between exercise in cough count per hour over the 24-h monitoring period or the number of coughs in the first hour after exercise.HME masks can attenuate EIB when exercising in cold, dry environments. The SHAM mask may not have been entirely inert, demonstrating the challenges of running randomised control trials utilising control and sham conditions.

scholarly journals Oscillometric and Spirometric Bronchodilator Response in Preschool Children with and without Asthma

2012 ◽  
Vol 19 (4) ◽  
pp. 273-277 ◽  
Author(s):  
Youn Ho Shin ◽  
Sun Jung Jang ◽  
Jung Won Yoon ◽  
Hye Mi Jee ◽  
Sun Hee Choi ◽  
...  
Keyword(s):  
Preschool Children ◽  
Forced Vital Capacity ◽  
Vital Capacity ◽  
Forced Expiratory Volume ◽  
Bronchodilator Response ◽  
Asthmatic Children ◽  
Before And After ◽  
Forced Expiratory Flow ◽  
Quality Control Criteria ◽  
Control Criteria

BACKGROUND: Bronchodilator responses (BDR) are routinely used in the diagnosis and management of asthma; however, their acceptability and repeatability have not been evaluated using quality control criteria for preschool children.OBJECTIVES: To compare conventional spirometry with an impulse oscillometry system (IOS) in healthy and asthmatic preschool children.METHODS: Data from 30 asthmatic children and 29 controls (two to six years of age) who underwent IOS and spirometry before and after salbutamol administration were analyzed.RESULTS: Stable asthmatic subjects significantly differed versus controls in their spirometry-assessed BDR (forced expiratory volume in 1 s [FEV1], forced vital capacity and forced expiratory flow at 25% to 75% of forced vital capacity) as well as their IOS-assessed BDR (respiratory resistance at 5 Hz [Rrs5], respiratory reactance at 5 Hz and area under the reactance curve). However, comparisons based on the area under the ROC curve for ΔFEV1% initial versus ΔRrs5% initial were 0.82 (95% CI 0.71 to 0.93) and 0.75 (95% CI 0.62 to 0.87), respectively. Moreover, the sensitivity and specificity for ΔFEV1≥9% were 0.53 and 0.93, respectively. Importantly, sensitivity increased to 0.63 when either ΔFEV1≥9% or ΔRrs5≥29% was considered as an additional criterion for the diagnosis of asthma.CONCLUSION: The accuracy of asthma diagnosis in preschool children may be increased by combining spirometry with IOS when measuring BDR.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Economic evaluation of DVd versus VAd in the treatment of multiple myeloma: Results from a phase III multicenter randomized clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6050-6050
Author(s):  
R. M. Rifkin ◽  
M. Hussein ◽  
R. Iskandar ◽  
A. O’Sullivan ◽  
D. Thompson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Economic Evaluation ◽  
Drug Administration ◽  
Study Drug ◽  
Phase Iii ◽  
Study Drug Administration ◽  
Reduced Dose ◽  
Hospitalization Costs

6050 Background: A randomized Phase III clinical trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone (DVd) versus conventional doxorubicin, vincristine, and reduced-dose dexamethasone (VAd) found similar efficacy in the treatment of newly-diagnosed multiple myeloma (Cancer, in press). However, observed clinical advantages of DVd included less toxicity and supportive care. (Cancer In press). Methods: This economic evaluation was conducted as a piggyback to the clinical trial. Utilization data were collected prospectively for enrolled patients (DVd = 97; VAd = 95). Costs were estimated by applying standard US unit costs in 2004 to observed utilization. We compared resource utilization and costs for study drug administration, other care (hospitalizations due to AEs, tests, transfusions, and concomitant medications), and total costs during follow-up for patients receiving DVd versus VAd using 2-sided t-tests. Results: DVd patients required significantly fewer hospital (1.5 vs 8.5; p < 0.01) and clinic days (4.8 vs 14.4; p < 0.01) for study drug administration. Costs of study drug were significantly higher for DVd patients ($16,181 vs $788; p < 0.01), but lower hospitalization costs ($3,311 vs $18,492; p < 0.01) and clinic costs ($797 vs $2,412; p < 0.01) for drug administration more than offset these costs, resulting in nominally lower overall study drug administration costs for DVd versus VAd ($20,289 vs $21,692; p = 0.64). No other component of care differed significantly between the two groups (costs of other care: $14,152 for DVd vs $14,154 for VAd; p = 0.99) and overall treatment costs ($34,442 for DVd vs $35,846 for VAd; p = 0.76) were similar in the two groups. DVd patients had approximately 10 additional days of follow-up over the trial period (149.4 vs 139.2) versus VAd patients. Conclusions: Despite higher drug acquisition costs, use of DVd did not increase the overall cost of treatment compared to VAd. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document