Introduction
In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct.
Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three studies of Indacaterol/Glycopyrronium conducted at a CRO, emphasizing the critical factors contributing to variability and results in inhalation studies.
Zenovel has identified critical points that significantly contribute to variability in these studies, ultimately affecting the final results.
Challenges in Inhalation Studies
Inhalation studies are rife with challenges, primarily driven by the intricate nature of the inhalation process and subject-to-subject variability. The following factors have been identified as pivotal contributors to variability and final results:
- Improper Inhalation Techniques: Variability arises due to hand-lung discoordination.
- Training Requirements: Proper training on the device and placebo is essential, with two to three training sessions needed to acquaint subjects with the device and dosing procedures.
- Breath-Holding: Subjects must hold their breath for a specific duration.
- Avoiding Coughing: Coughing during inhalation, holding the breath, and exhalation can result in dose loss.
- Exhale Technique: Variability occurs when subjects exhale improperly, either through the mouth or nose.
- Doser Variability: Different dosers can guide subjects differently, affecting the dosing technique.
- Capsule Pricking: Missed capsule pricking can lead to time delays in the dosing process.
- Environmental Factors: Room temperature, moisture, and static charge can influence drug delivery.
- Chamber Design and Calibration: Proper chamber design and pressure gauge calibration are crucial.
Zenovel’s involvement in addressing these challenges included auditing the CRO’s inhalation setup and optimizing chamber functionality, ensuring consistent pressure even if one chamber was opened during dosing.
With extensive experience, Zenovel demonstrates the ability to minimize variability and ensure optimal compliance with established procedures.
Pre-Study Readiness
Zenovel emphasizes the importance of several pre-study readiness checks to ensure the success of inhalation studies encompassing:
- Proper Calibration
- Air Filter Replacement
- Temperature and Humidity Control
- Staff Training
- Air Replacement Rate
- Regulatory Compliance
- Subject Database
- Continuous Improvement
Zenovel observed an initial delay in sample collections, which was subsequently reduced, demonstrating our vigilance and dedication to monitoring.
Throughout our involvement, we offered guidance and suggestions to manage activities and ensure compliance with study protocols, playing a pivotal role in setting up inhalation studies and maintaining compliance.
Conclusion
Zenovel’s experience in monitoring inhalation studies, attention to detail, and commitment to addressing challenges have proven instrumental roles in enhancing compliance and minimizing variability in inhalation studies.
Our comprehensive approach to pre-study readiness and continuous improvement ensures that studies are conducted with the utmost precision, resulting in valuable, reliable data for clients.
Zenovel remains dedicated to achieving the best compliance through expert monitoring services.
