USING AKITA˛ ® IN CLINICAL TRIALS
AKITA˛ ® is especially suitable for use in dosing studies in the clinical evaluation of inhaled therapeutics. Several characteristics mark it out as the optimal system in clinical trials:
Dose Security and Targeting
By optimizing the flow rate during inspiration and tailoring it specifically to the breathing patterns of the patient, the variability of the drug dosage is reduced considerably. This enables very much more precise dosing, which in turn means that fewer patients are needed in clinical trials. That saves the drug developer time and money.
The use of patient-specific smartcards ensures that repeat dosing is consistent and reproducible and also allows for the targeting of different lung regions by aerosol-bolus technique. For example:
High Drug Amounts
Because AKITA is so efficient and the dosing so precise, high drug doses can be administered over a much shorter time frame. This means that both patients and clinicians do not have to undergo laborious long inhalation sessions.
Compliance Data
The AKITA records every inhalation treatment onto the smart card with a time stamp. In this way, non-compliance with the treatment regimen can be recognized and addressed at an early stage. This compliance data can also be an important support during data interpretation - giving an important input for development strategy.
Using AKITA˛ in early clinical trials in man for inhaled therapeutics
A lot of drug development projects focus on establishing a dry powder application for pulmonary delivery. Alhtough dry powder inhalers show clear advantages for mass markets like COPD and Asthma, significant investment is necessary for the development of the powder formulation, which may not be appropriate for early clinical trials.
However, it is still necessary to investigate the performance of the compound in man at the earliest possible date and before a powedered formaulation has been developed. These studies can be performed with liquid formulations as these are less expensive to manufacture, faster to develop and have lower formulation risk than a dry powder. In addition, it is likely to have been a liquid formulation during animal studies and dose escalation is simpler to conduct using dilution.
AKITA˛ ® is the leading edge delivery technology to use at this stage with liquid formulations. AKITA˛ ® offers highly precise dosing (see Fig. 1) and low patient variability meaning the numbers of patients in the trial can be very much lower than with alternative technologies. AKITA˛ ® also allows for very precise knowledge of exact lung dosages making decisions about formulation and delivery options for the final product very much easier to make. And since AKITA˛ ® allows for the exact determination of efficacious lung doses, determination of risk/benefit ratios can be made with much greater confidence.
Fig 1. The AKITA technology allows for precise lung dosing (from P. Brand et al: Reduction of drug-dose and therapy-costs in high-dose Tobramycin-Inhalation, ECFC 2007)