This paper reflects a scientific evaluation of the current state of the art on clinical trials of mucoactive drugs in chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD) as discussed by international experts. It has been structured in such a way as to constitute the basis for future guidelines birth control online.
This document is mainly concerned with the evaluation of clinical efficacy during the conduct of phase III studies. Safety aspects have deliberately not been addressed, but it is assumed that all clinical trial protocols will include appropriate methods for monitoring safety issues and collection of adverse drug events. It must be acknowledged that clinical development and relevant protocols should be tailored in respect to the uniqueness of each compound. Furthermore, all investigational protocols must be conducted according to good clinical practice (GCP).
The complexity of airway diseases and the many confounding factors in the therapeutic outcome can explain the difficulty associated with demonstrating the effectiveness by objective criteria and lack of conclusive data. In CB and COPD, even the definition of “event” (required to assess the improvement) is more problematic than in other diseases.
In recent years, in an attempt to avoid the use of subjective measurements related to global clinical scores of the patient’s status, standardized scores, “objective” quantitative outcomes such as pulmonary function tests, mucociliary and tussive clearances, rheologic measurements and biochemical data, and evaluation of volumes of expectoration have been proposed. This position paper applies to all mucoactive drugs (new chemical entities [NCEs] and established medicinal products or new combinations thereof) to be used in CB and COPD because these diseases are characterized by quali-quantitative alterations of mucus and by modification in the associated relationship between mucus, cilia, and periciliary fluid.