Secondary end points include: (1) cough frequency, severity, and efficiency; (2) ease of expectoration; (3) chest discomfort; (4) dyspnea; (5) quality of life; (6) economic factors; (7) patient’s global assessment; (8) physician’s global assessment; (9) pulmonary function parameters; (10) exercise pulmonary function; (11) blood gases; (12) biochemical or other surrogate markers; and (13) sleep dysfunction and nocturnal oxygen saturation. canadian neighbor pharmacy
Measurements are based on the number of acute exacerbations. Hospital visits should be performed at a maximum of 3-month intervals, depending on the duration of the study which should last at least 6 months. Pulmonary function should be assessed by lung volumes, spirometry, exercise studies, ventilation perfusion isotope studies at 6-month intervals according to the standardization of tests of the American Thoracic Society and of the European Community for Coal and Steel. A run-in period is essential in order to establish baseline data and to familiarize the patient with the study procedure.
Pharmacoeconomics is increasingly becoming one of the factors affecting regulatory decisions, which can be influenced by cost-containment policies. It is therefore being addressed more frequently in clinical trials. This aspect is particularly relevant when incapacitating diseases are involved, such as CB and COPD.
Variables found in the literature on mucoactive drugs which are relevant to pharmacoeconomic perspectives are the following: number of acute episodes; number of hospitalizations and reduction in hospital days because of acute episodes; days of illness per year due to acute episodes of bronchitis; lost working days; and reduction in antibiotic consumption (days of antibiotic therapy) during exacerbations.
While some measures of QoL are derived from general health questionnaires, it is desirable that trials include measures from disease-specific QoL instruments. Such measures must be reliable, sensitive, and internationally valid. natural inhalers for asthma
To ensure scientific credibility in multinational trials with mucoactive drugs, QoL questionnaires or procedures not employing questionnaires have to overcome problems of cross-culture translation equivalence and intergroup differences. Equating items for variations in cultural perceptions of meaning and value presents the major psychometric challenge. Work in related areas, such as asthma, has demonstrated that problems of comparison in the UK and Italy have been resolved satisfactorily.
Criteria for removal of patients should be prospectively defined and reported in the final report or publication. Criteria for entrance into statistical evaluation should be given.
The sample size should be defined prestudy, preferably in terms of power to detect a difference in the primary variable or end point. If practical limitations exist, they should be stated.
Large studies require multicenter trials which present obvious advantages but introduce an extra source of variation, ie, variation between centers which should be taken into account when analyzing data. The statistical analytical plan depends upon the trial design and should be based on intention-to-treat; it should be the simplest possible and supported by relevant data. buy ventolin inhaler
Long-term Treatment: In principle, all the recommendations relevant to the acute episodes also apply to chronic treatment. In chronic treatment, two therapeutic objectives may also be considered: (a) symptomatic relief; and (b) modification of the natural history of disease.
Symptomatic relief—Therapeutic aims include improvement of symptoms such as cough (frequency/severity) and difficulty in expectoration.
In clinical trials, the following primary end point(s) should be pursued: (1) cough frequency and severity; (2) ease of expectoration; (3) chest discomfort; (4) dyspnea; (5) patient’s global assessment; and (6) physician’s global assessment.
Secondary end points for symptomatic relief should take into account: (1) pulmonary function parameters; and (2) quality of life and economic factors. Flovent Inhaler
Acute Episodes: Aims of mucoactive therapy in acute episodes of bronchitis include the following: ease of expectoration; decrease in volume of sputum; decrease in cough (frequency and severity); shortened duration of the acute episode; and reduction in concomitant medications (eg, antibiotics).
Therefore, in clinical trials, the following primary end point(s) should be pursued: (1) ease of expectoration; (2) cough frequency/severity; and (3) shortened duration of acute episode, more relevant for inpatients than for outpatients.
The following secondary end points may be considered: (1) sputum volume; (2) shorter duration of episode for outpatients; (3) patient’s global assessment; (4) physician’s global assessment; (5) reduction in concomitant medications; (6) dyspnea; and (7) pulmonary function. canadianfamilypharmacy
Different end points may require different suitable eligibility criteria, with the aim of reducing individual variability as much as possible and facilitating significant outcomes.
Patients with concomitant illnesses and treatments may be admitted, provided that confounding factors influencing the assessment of results are not introduced. Particular attention should be paid to the concomitant use of bronchodilators, antibiotics, and to physiotherapy. If concomitant therapy is needed, its dosage should not be changed during the whole study period.
Acute exacerbations result from various etiologies, such as viral and bacterial infections, and are influenced by environmental factors, such as air pollution. Depending on the severity of the underlying respiratory disease and airway obstruction, respiratory failure and pulmonary hypertension may occur. When designing clinical studies, the suggested clinical criteria, described in “Clinical Studies’ should be considered. canadian helth& care mall
Ventilation/ perfusion mismatch can develop with increasing severity of the disease, leading to variations in gas exchange; hence, the expired minute ventilation and the ratio of dead space to tidal volume together with blood gases should be measured to monitor such changes. Since a direct effect of mucoactive drugs on pulmonary function is not expected, measurement of pulmonary function should not represent a primary end point. Although statistically significant changes can be demonstrated, their clinical relevance should be carefully addressed.
Methods which destroy the mucus gel during measurement are of no use. The techniques which can produce useful data are, for example, creep compliance and dynamic (oscillatory) testing, as well as appropriate tensiometers. The moduli obtained by these methods will give an indication of transport of the mucus on a ciliated epithelium.
In disease states, elasticity and viscosity and adhesiveness of mucus are known to be altered, and mucoactive drugs are intended to normalize these parameters. However, results from clinical trials are often confounded by large interpatient and intrapatient variation in terms of rheologic measurements, and it is therefore very important to ensure that patient groups are as clinically homogeneous as possible. canadian neighbor pharmacy online