Recommendations for Guidelines on Clinical Trials of Mucoactive Drugs in Chronic Bronchitis and Chronic Obstructive Pulmonary Disease: Target Population

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.
Group stratification must be considered prospectively, taking into consideration the following: age (more than 40 years of age); disease duration; special habits (eg, smokers and exsmokers, smoking exposure); documented history of chronic mucus hypersecretion; and particular features of clinical history (eg, number of bronchitic exacerbations in a defined period). Practical limitations to patient inclusion should be specified. canadian neighbor pharmacy online

For trials related to acute episodes, the following additional inclusion criteria may be considered: presence/absence of airway obstruction; presence/ absence of respiratory failure; severity scores; nutritional status; and inpatients or outpatients.
Since a large percentage of the population affected by CB and COPD fall into an age range over 65 years, it is also important that the study population includes geriatric subjects so that results can be extrapolated to the actual population likely to use the drug. Basic Exclusion Criteria: Patients suffering from asthma, cystic fibrosis, or assessed diagnosis of bronchiectasis, pneumonia, or other chronic severe diseases which can interfere with the outcome should be excluded. Patients receiving antitussive drugs, other mucoactive compounds, or patients using inhaled and oral steroids and beta2-agonists for a short time before study start must be excluded.

This entry was posted in Pulmonary Function and tagged airway obstruction, bronchitis, mucoactive drugs, pulmonary function.