Valois Pharma revealed the results of a clinical study with patients suffering from asthma and chronic obstructive pulmonary disease (COPD) using its proprietary Prohaler dry powder inhaler on World Asthma Day.
According to the World Health Organization, there are 300 million asthma sufferers worldwide. The majority of respiratory treatments are via the pulmonary route, using either Metered Dose Inhalers (MDIs) or more recent Dry Powder Inhalers (DPIs). DPIs are said to be easier to use because they eliminate the problem of synchronisation between actuation and inhalation. In addition, DPIs do not contain propellant and are therefore more environmentally friendly.
To ensure the Prohaler would be intuitive and easy-to-use, Valois Pharma placed the patient at the centre of the development process from the start of the project in 2004. An initial set of studies focused on patient handling of the device and results released in June 2008 confirmed that Prohaler was easy to handle and intuitive to use.
Three simple steps are all it takes for a patient to use Prohaler: open the device, inhale, and close it. Inhaling triggers the release of a dose of medication. A dose counter reminds the patient how many doses are left in the device.
The next step was to take these investigations further by understanding the patient/device interface during inhalation and verifying that all the necessary conditions were met for the correct dose of medication to be administered.
A hospital-based study was carried out from December 2007 to April 2009 at the CHRU in Tours, France, led by Professor Patrice Diot, an eminent respiratory physician and President of ISAM (the International Society for Aerosols in Medicine), and Dr Steve Newman, an expert in inhaled dosage forms and founder of Pharmaceutical Profiles.
Sixty patients suffering from asthma or COPD took part in the two-phase study. Some had very poor lung capacity, as low as 30% of a healthy person.
The results of the first phase of the study showed that all the patients, regardless of how ill they were, could trigger the device and inhale enough air for the medication to reach their lungs.
Final results from the study will be published in the coming months.