CRS has all sorts of experience from conducting more than 60 trials in the past 8 years. In the indications asthma, chronic obstructive pulmonary disease (COPD), and allergy CRS has successfully accomplished trials with New Chemical Entities (NCE), New Biologic Entities (NBE) as well as generics. CRS has realized Proof of Concept (PoC), First in Human (FiH), PharmacoKinetic (PK), and PharmacoDynamic (PD) trials.
Our clinical trial sites are equipped with digital spirometry, body plethysmography, diffusing capacity of lung for carbon monoxide (DLCO) measurement and ergospirometry. Our staff, with its broad clinical experience, has been involved in numerous early phase respiratory clinical trials and, thus, CRS is a reliable partner for your drug development.
Today, buccal, intranasal or intrapulmonal drug administration is of high interest for the specific treatment of certain diseases.
A buccal or intranasal drug application can be used when rapid absorption and avoidance of the first-pass metabolism are required – this might be relevant, e.g., for medications of hormones or analgesics.
The buccal or nasal mucosa is well suited for a non-invasive systemic administration of different drugs. Via this rout the administered drug is bypassing the entero-hepatic circulation. This is particularly important for those medications that are metabolized quickly when administered orally – e.g., hormones like calcitonin or desmopressin.
The rapid absorption of drugs via the buccal or nasal mucosa can also be applied for pain medications (e.g., fentanyl nasal sprays, triptane for migraine), for rescue medications (e.g., glucagon in hypoglycaemia, naloxone for opioid overdosing) or for crisis intervention medictions (e.g., midazolam – especially in children).
The intranasal application may also be an appropriate route for certain vaccines.
An important consideration with regard to these medications is that buccal or intranasal administration has been determined to be a non-invasive route of administration and is easy to do in terms of self-administration.
CRS has huge experience in performing early clinical development studies in different kind of buccal or nasal applications.
Drug inhalation offers a number of advantages in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Through direct delivery to the lung – on the one hand – a high pulmonary concentration of the appropriate drug is achieved with a low systemic concentration. As a consequence, inhalation of such a drug is usually associated with high pulmonary efficacy and minimal systemic side effects.
On the other hand, certain pharmaceuticals can pass over the capillary membrane of the pulmonary alveoli. Inhalation of those drugs allows a fast absorption and bypassing the entero-hepatic first pass effect.
Whatever, the lung is an organ with a complex structure and multiple pulmonary-specific pharmacokinetic processes. Consequently, the development of inhalation products, respectively the design of inhaled drugs should be based on a thorough and complete understanding of all pulmonary pharmacokinetic processes.
We at CRS, with more than 40 years of experience in performing clinical trials, have a thorough understanding of all these processes.