Respiratory conditions

Clinical trial of a new composition of an existing compound that is being developed for the treatment of respiratory conditions

The research physician about this research

In this study we will look at the blood levels of the approved drug salbutamol. This drug is already available on the market for the treatment of respiratory conditions. Salbutamol is administered by using an inhaler (puffs). For the salbutamol to be dispensed from the inhaler, a propellant is used. A propellant is for example also used to get the deodorant from a deodorant canister. The propellant in the puff that is usually used to dose salbutamol is a potent greenhouse gas. Therefore, an alternative propellant is being tested that has a lower carbon footprint and a version of this alternative propellant that also has a longer shelf life. This is more sustainable: fewer environmentally unfriendly substances are released during administration.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

Important information about this study

• The puff is already used by asthma patients
• The drug has been used by patients since 1968
• On the first day you will receive a 'training' on how to use the inhaler

Who can participate?

• You are a healthy male or female.
• You are at least 18 and at most 55 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. 
• You do not smoke and you do not use any nicotine-containing products.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit).
• For this trial, you cannot (have) receive(d) any vaccine (including COVID-19) within 2 weeks prior to the start until the end of your stay in the research facility.
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

• You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
• You are using a copper intra-uterine device in combination with a condom;
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized or your male partner has been sterilized;
• You are not sexually active according to your lifestyle;
• You are only sexually active with a partner of the same sex.

As a male you can only participate if you meet one of the following conditions:

• You are using a condom in combination with an additional contraception method used by your female partner;
• You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
• You are not sexually active according to your lifestyle;
• You are only sexually active with a partner of the same sex.