Double-Blind, Double-Dummy, Multinational, Multicenter, Parallel-Group Design Clinical Trial of Clinical Non-Inferiority of Formoterol 12 μg/Unit Dose in a b.i.d. Regimen Administered via an HFA-Propellant-pMDI or a Dry Powder Inhaler in a 12-Week Treatment Period of Moderate to Severe Stable Persistent Asthma in Adult Patients

Respiration ◽  
2005 ◽  
Vol 72 (1) ◽  
pp. 20-27 ◽  
Author(s):  
D. Dusser ◽  
E. Vicaut ◽  
G. Lefrançois
Keyword(s):  
Clinical Trial ◽  
Treatment Period ◽  
Dry Powder Inhaler ◽  
Persistent Asthma ◽  
Dry Powder ◽  
Double Blind ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Unit Dose

scholarly journals Inhaled budesonide for adults with mild-to-moderate asthma: a randomized placebo-controlled, double-blind clinical trial

2001 ◽  
Vol 119 (5) ◽  
pp. 169-174 ◽  
Author(s):  
Ana Luisa Godoy Fernandes ◽  
Sonia Maria Faresin ◽  
Maria Marta Amorim ◽  
Carlos Cézar Fritscher ◽  
Carlos Alberto de Castro Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peak Expiratory Flow ◽  
Dry Powder Inhaler ◽  
Dry Powder ◽  
Double Blind ◽  
Bronchodilator Therapy ◽  
Moderate Asthma ◽  
Morning Peak Expiratory Flow ◽  
Double Blind Clinical Trial ◽  
Inhaled Budesonide

CONTEXT: Budesonide is an inhaled corticosteroid with high topical potency and low systemic activity recommended in the treatment of chronic asthma. OBJECTIVE: This study was conducted to determine the efficacy and safety of inhaled budesonide via a breath-activated, multi-dose, dry-powder inhaler. TYPE OF STUDY: Multicenter randomized parallel-group, placebo-controlled, double-blind, clinical trial. SETTING: Multicenter study in the university units. PARTICIPANTS: Adult patients with mild-to-moderate asthma that was not controlled using bronchodilator therapy alone. PROCEDURES: Comparison of budesonide 400 µg administered twice daily via a breath-activated, multi-dose, dry-powder inhaler with placebo, in 43 adult patients (aged 15 to 78 years) with mild-to-moderate asthma (FEV1 71% of predicted normal) that was not controlled using bronchodilator therapy alone. MAIN MEASUREMENTS: Efficacy was assessed by pulmonary function tests and asthma symptom control (as perceived by the patients) and the use of rescue medication. RESULTS: Budesonide 400 µg (bid) was significantly more effective than placebo in improving morning peak expiratory flow (mean difference: 67.9 l/min; P < 0.005) and FEV1 (mean difference: 0.60 l; P < 0.005) over the 8-week treatment period. Onset of action, assessed by morning peak expiratory flow, occurred within the first two weeks of treatment. CONCLUSIONS: Budesonide via a breath-activated, multi-dose, dry-powder inhaler results in a rapid onset of asthma control, which is maintained over time and is well tolerated in adults with mild-to-moderate asthma.

A Comparison of Paroxetine, Imipramine and Placebo in Depressed Out-patients

1991 ◽  
Vol 159 (3) ◽  
pp. 394-398 ◽  
Author(s):  
G. C. Dunbar ◽  
J. B. Cohn ◽  
L. F. Fabre ◽  
J. P. Feighner ◽  
R. R. Fieve ◽  
...  
Keyword(s):  
Side Effects ◽  
Beneficial Effect ◽  
Anxiety Symptoms ◽  
Drop Out ◽  
Antidepressant Effect ◽  
Double Blind ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Antidepressant Efficacy

To compare the safety and antidepressant efficacy of paroxetine, imipramine, and placebo, data from six centres using the same protocol were pooled. A double-blind parallel-group design was used, with therapy lasting six weeks. From week 2 onwards, both the 240 paroxetine-treated and the 237 imipramine-treated patients were significantly different from the 240 placebo-treated patients, but no different from each other. Side-effects with paroxetine were less likely to lead to drop-out than with imipramine. Paroxetine had a possible earlier antidepressant effect than imipramine, and a possible earlier beneficial effect on anxiety symptoms associated with depression.

scholarly journals Design and analysis of stratified clinical trials in the presence of bias

2019 ◽  
Vol 29 (6) ◽  
pp. 1715-1727 ◽  
Author(s):  
Ralf-Dieter Hilgers ◽  
Martin Manolov ◽  
Nicole Heussen ◽  
William F Rosenberger
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Selection Bias ◽  
Time Trend ◽  
T Test ◽  
Group Design ◽  
Bias Model ◽  
Parallel Group Design ◽  
Parallel Group ◽  
The Impact

Background Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a randomization procedure mitigates the impact of bias on the test decision in clinical trial stratified by center. Methods We use the weighted t test to analyze the data from a clinical trial stratified by center with a two-arm parallel group design, an intended 1:1 allocation ratio, aiming to prove a superiority hypothesis with a continuous normal endpoint without interim analysis and no adaptation in the randomization process. The derivation is based on the weighted t test under misclassification, i.e. ignoring bias. An additive bias model combing selection bias and time-trend bias is linked to different stratified randomization procedures. Results Various aspects to formulate stratified versions of randomization procedures are discussed. A formula for sample size calculation of the weighted t test is derived and used to specify the tolerated imbalance allowed by some randomization procedures. The distribution of the weighted t test under misclassification is deduced, taking the sequence of patient allocation to treatment, i.e. the randomization sequence into account. An additive bias model combining selection bias and time-trend bias at strata level linked to the applied randomization sequence is proposed. With these before mentioned components, the potential impact of bias on the type one error probability depending on the selected randomization sequence and thus the randomization procedure is formally derived and exemplarily calculated within a numerical evaluation study. Conclusion The proposed biasing policy and test distribution are necessary to conduct an evaluation of the comparative performance of (stratified) randomization procedure in multi-center clinical trials with a two-arm parallel group design. It enables the choice of the best practice procedure. The evaluation stimulates the discussion about the level of evidence resulting in those kind of clinical trials.

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