Specialised Clinical Trials

INAMED is a speciality CRO with particular expertise in inhalation medicine.

In our own facility we investigate your new medical device or your new drug by in-vitro and in specialised clinical trials, such as:
• Lung Deposition of Radioactive Labelled Drugs/Lung Scintigraphy Trials
• Investigation of Mucociliary Clearance
• Drug Targeting Studies
• Determination of Inhalation Patterns
• Operating as a Site in Multi-Centre Trials
• Feasibility/Performance/Handling/Efficacy/Safety/BE/PK/PD Trials
• ¹⁴C ADME trials
• Sleep Laboratory Investigations

Lung Deposition – a key parameter for an effective inhalation device

Only a little amount of the inhaled aerosol reaches those regions of the respiratory tract where it is needed. We characterise the effects of your formulation, your device, and your patients breathing patterns on drug deposition in the respiratory tract. Deposition data will help to optimise your device in the early phase of development.

Likewise, to determine the dose of your drug, which does reach the lungs, deposition trials are the way to go. Inamed offers sophisticated techniques to label your drug radioactively and to visualise its deposition in the respiratory tract.

• Total and regional deposition using radiolabeled test aerosols or radiolabeled drugs.
• Influence of breathing pattern on total and regional deposition with non-radioactive test particles.

Determination of Inhalation Patterns

Please contact us for detailed information.

Mucociliary Clearance

Your drugs could have positive or negative effects on the lung clearance. We help you to characterise the effects of your drug on the lung clearance function.
• Short term clearance from conducting airways with radiolabeled test aerosols.
• Imaging of intrapulmonary drug distribution using our 2D-graphic gamma camera or 3D gamma camera (SPECT) imaging.

Pilot/Feasibility/Safety/Efficay/BE/PK/PD trials

Those trials are important tools for the early phase of drug development and will help to choose the right path in drug development. INAMED assists in this important process to find the right design for the trial. It is one of our specialties to help you to characterise your drug and its influence on the human respiratory tract by means of various lung function tests, deposition measurements, mucociliary clearance measurements, or pharmacokinetic investigations.

Sleep Laboratory Investigations

Our experienced team – together with the well equipped facility – can provide those sleep laboratory investigstions which you can expect for your important project
• 8 Beds
• State-of-the-Art Equipment
• Monitored Polysomnography (staff, infra red video control, etc.)
• Complete Polysomnography Recording
• Scoring according AASM, 2007 is possible
• > 10 years accredited according DGSM Standard (Deutsche Gesellschaft für Schlafforschung und Schlafmedizin = German Sleep Society)
• One of the TOP TEN in a recent quality study performed at 117 sleep laboratories

Lung function tests – Our laboratories are state of the art

If your drug/treatment should have positive or no effects on your patient’s lung function parameters, we investigate lung function parameters in clinical studies for you. Our personnel has best practice and training in lung function measurement.
• Bodyplethysmography
• Spirometry
• Ergospirometry
• Bronchial challenge

Contact us!