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PRA-GSKBGB33-0D1RNS

Respiratory conditions

  • M/F
  • 18 - 55 years old
  • Non-smoker
  • Healthy

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

Every time a very pleasant and educational experience

Milan

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You weigh between 45 and 110 kg
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2
  • Non-smoker

Good to know about this trial

  • This examination has 1 residential period and the follow-up is by telephone.
  • The study compound is administered via an inhaler.
  • The research compound salbutamol is already on the market and is used, for example, in the treatment of asthma.

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

In this trial we will look at the levels of the approved drug salbutamol in the blood. This drug is already available on the market for the treatment of respiratory conditions such as asthma and COPD. Salbutamol is administered by using an inhaler (puff). An inhaler contains the active ingredient (medicine) salbutamol and a propellant which helps to dispense the medicine out of the device for it to be inhaled by the user. The propellant that is currently used in inhalers to dose salbutamol has a significant global warming potential. Therefore, an alternative propellant that is less harmful for the environment will be tested.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 45kg and at most 110 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m2. 
  • You have not used any tobacco or nicotine containing products within six months prior to screening.

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).
  • To determine if you are suitable to participate in this trial, you will undergo two separate screenings; one will be a medical screening, depending on availability, this can be performed in Groningen or in Utrecht. The second screening will be for a spirometry assessment, which will be performed in Groningen once you have passed the first medical screening.
    • Spirometry is where your lung function will be measured during the screening phase of the trial, using a special device in which you have to blow as hard as you can and as much as you can.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions from at least 4 weeks prior to the first administration of the study compound:

  • 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of €2895 for participation in the trial.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE

Period of stay and research

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 12 days (11 nights). The follow-up visit will be telephonic and will take place within 7 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.

Frequently asked questions

You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.

During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.

Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.

A trial usually involves 5 to 12 participants. The groups are set up so they best match the requirements of the trial. These requirements are described for each trial. View all current trials.

Current trials

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