Inhalative application of drugs

Delivery of the drug substance into the lungs or to the nasal mucosa means following a path normally not intended for absorption. The administration process itself is an artificial one and thus requires thorough training, success control and supervision – in healthy subjects as well as in symptomatic patients. The devices often need to be primed and handling requires a high level of care.

Pressurised or breath-operated metered dose inhalers, inhalers with spacers or holding chambers, non-pressurised, pump-activated, liquid reservoir MDIs, dry-powder inhalers with reservoirs and metering mechanisms or pre-dispensed doses and of course the solutions and suspensions for nebulation – are all in a their own way unique and such is their handling.

Standardised processes, established operating procedures, experienced staff – are always prerequisites for successful early clinical trials –but are particularly vital here.

Our study team is highly experienced in all such trials and realises these practical procedures on the highest level of standardisation possible. Study-specific working instructions based on your SmPC are created in the German language and trained repeatedly.

Clinical trials

We may already be involved in setting up your clinical development program. But if this is not the case, we are only able to perform the clinical trials needed for:

  • Therapeutic equivalence studies in patients (Asthma and COPD)
  • Pharmacodynamic studies (bronchodilating effect / improved airway function, bronchoprotection studies, challenge studies)
  • Pharmacokinetic / dose linearity / systemic exposure trials single dose and at steady state with and without charcoal administration
  • Hypothalamic pituitary adrenocortical (HPA) axis studies.
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