Pulmology

With a focus on inhalatives and inhalation devices

Since the early 2000s, CRS has conducted more than 60 trials   with a background in respiratory research and treatment of asthma and chronic obstructive pulmonary disease (copd). In these trials a total of more than 1,700  healthy volunteers and patients have been included.

The focus of these trials was on inhalatives – new chemical entities (NCE), new biological entities (NBE) as well as generics – and inhalation devices. The types of trials were first-in-human (FiH), pharmacokinetics (PK), pharmacodynamics (PD), bioequivalence (BE), and proof of concept (PoC) trials.

CRS – appreciated expert for standard trials and special trial requirements

CRS is well experienced not just with the more standard early phase respiratory trials, of which it has conducted more than 40 such trials. CRS staff is also appreciated by clients for its high level of knowledge on special trial requirements and has successfully completed several of such projects.

CRS Mannheim for instance, the largest CRS unit, has realized a trial with cystic fibrosis patients. The recruitment and care of this highly selected patient population was achieved in collaboration with a center of excellence in this field. For that project, one of the wards at the Mannheim clinic was adapted to the specific requirements for such a trial and was exclusively used for the cystic fibrosis patients, isolated from the rest of the clinic.

A pitfall in the inhalation treatment is the inhalation maneuver. If it is not correctly executed it might result in insufficient drug deposition into the airways and poor PK results. Moreover, it is of great importance to have a sharp peak in the serum concentration of the administered drug respectively a steep concentration/time curve within the first 15 minutes, which is a proof of a correct inhalation maneuver. If this peak misses or is rather low it is probably due to a poor inhalation technique.

Thus, CRS staff is extensively trained for inhalation studies and only certified staff is allowed to administer inhalative drugs to study participants. These study participants, patients or healthy volunteers, are also intensively trained during the screening procedure and before start of the clinical trial in order to make them acquainted with the complicated procedure of using an inhalation device and to reduce intra-individual variability of the breathing technique during drug administration.

For training purposes the In-Check DIAL is used as a training tool. It enables clinicians to train patients or study participants to the proper breathing technique, considering force and flow rate to achieve each time an optimal deposition of the medication being inhaled into the lungs.

CRS staff is most experienced with these and all other important issues in respiratory research and in trials on the treatment of respiratory diseases.

CRS´s trial sites are adequately equipped for clinical trials in this field with all state-of-the-art technology for respiratory assessments, e.g.:

  • Spirometry (FEV, PEV, PEFT) including reversibility testing
  • Spiroergometry
  • Pulmonary function testing
  • Metacholine challenge test
  • Allergen challenge tests
  • Skin prick tests
  • Body plethysmography
  • Induced sputum, nasal provocation & lavage

Many of the trials on pharmacokinetics (PK) of inhalatives have been designed using charcoal blockage in order to avoid gastrointestinal absorption of the test formulation.

Due to the high potential for contamination based on chemical properties of some of the tested substances, CRS has developed a study set up, which strictly avoids such accidental contamination using clear instructions and separation of staff and functional labs where study specific activities, dosing and blood sampling are performed.

Two clinical trials with single and multiple ascending doses (SAD/MAD) with a new chemical entity (NCE) for inhalation treatment of cystic fibrosis, in 56 respectively 50 healthy volunteers with multiple spirometric assessments during the trial.

Multiple dose escalation trial with a new chemical entity (NCE) for inhalation treatment of acute respiratory distress syndrome (ARDS) in 18 healthy volunteers, involving methacholine challenge test before inclusion and multiple lung function/spirometric profiles during study.

Testing the effect of a known substance on the maximal oxygen consumption (VO2 max): A study involving 90 healthy volunteers over four months and 44 study visits undergoing repeated treadmill tests in order to evaluate changes of VO2 max as a measure of exercise capacity and trainability after repeated inhalation of the substance.

Due to the high potential for contamination based on chemical properties of some of the tested substances, CRS has developed a study set up, which strictly avoids such accidential contamination using clear instructions and separation of  staff and functional labs where study specific activities, dosing and blood sampling are performed.

REACHING OUT IS EASY AND FAST – LET’S TALK

Prof. Dr. Thomas Forst

Chairman of the Executive Board

LET’S TALK SCIENCE
Martin Mulder

Senior Vice President Corporate & Business Development

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CRO Leadership Awards 2019

CRS is proud to be recognised again by pharma companies worldwide as a leading CRO with regard to: capabilities, compatibility, quality and reliability.

European Biotechnology Guide

Find CRS’s company profile in the European Biotechnology Science Industry Guide, volume 9 2019.

EcoVadis – CSR Rating

Based on the CSR rating by EcoVadis in 2022 CRS has been granted Silver Recognition Level.