Primary and Secondary Efficacy Parameters (Table 1)

The eight primary efficacy parameters included assessments of the following: cough frequency, cough severity, chest discomfort, and dyspnea at visits 1, 2, 3; and the patients’ evaluation of the ease of raising sputum, patients’ global assessment and physicians’ global assessment at visits 2 and 3; and a derived patients’ global assessment at visits 1, 2, and 3. The derived patients’ global assessment was defined as the sum of symptom scores (cough frequency, cough severity, chest discomfort, dyspnea). Each patient was familiarized with the Patient Evaluation Questionnaire which contained a definition of each rating scale.

The six secondary efficacy parameters analyzed included the following: frequency of aerosol bronchodilator use, the incidence and the duration of acute exacerbations of chronic bronchitis, the frequency of concomitant medication use, the incidence of adverse experiences, and the incidence of dropouts. Viagra Professional

Table 1—Barometers for the Analysis of Efficacy

Primary

Secondary

Cough frequency

Bronchodilator
use

Cough severity

Incidence-acute
exacerbations

Chest discomfort
(tightness

Duration-acute
exacerbations

and congestion)

Frequency of
concomitant

Dyspnea (difficulty
in

medication use

breathing)

Incidence of
adverse

Ease in bringing
up sputum

experiences

(global
assessment)

Incidence of
dropouts

Patients’ global
assessment

Physicians*
global assessment

Patients’
derived global

assessment

Statistical Analyses

The National Mucolytic Study used the two-group parametric, unpaired Student t-test in three different modes: (1) as a check on the adequacy and consistency of the computer-generated random assignment, the baseline (visit 1) pre-treatment outcome measures were disaggregated by treatment status and group comparisons were made; (2) biodemographic data also were disaggregated by treatment status to test for initial group comparability; and (3) the parametric t-tests were used to analyze group differences for the post-treatment primary and secondary efficacy variables at visits 2 and 3.

In portions of the study where f-tests were inappropriate, cross tabulation analyses were used extensively. In the case of 2 X 2 tables, the Fishers exact test was used as a general test for the existence of a relationship. This test was usually regarded as more conservative than the Pearson chi square test. Where larger than 2×2 tables were required and where the model of the relationship required a test of “trend” (generally a monotonic increase or decrease). The Mantel-Haenszel chi square was employed. Statistical significance was declared at the 0.05 level for all tests, and the p-values were expressed as one-tail probabilities. The statistical analysis was done using PC-SAS version 6.03 for microcomputers. Data management was independently conducted by Clinical Sciences, Inc, of Be- thesda, MD. canadian antibiotics

Two overall analyses were planned. First, a strict intention-to- treat analysis was done in which all entered patients were included. Second, since the study design included patients who were mildly symptomatic, analyses were planned to examine the treatment effects on the more symptomatic patients without the dilutional effects of the mildly symptomatic patients.

Category: Diseases / Tags: lodinated Glycerol, Mucolytic Study, Obstructive Bronchitis, placebo-controlled study

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