Certain drugs are administered by using an inhaler (puffs). An inhaler may contain propellant to get the right amount of the medicine into the lungs in the right way. Some of the propellants used in inhalers are greenhouse gasses and are therefore…
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To characterise the PK of single doses of salbutamol in healthy participants
delivered via an MDI containing propellant HFA-152a, and to compare to
an MDI containing propellant HFA-134a
Secondary outcome
Pharmacokinetics: To characterise the PK of single doses of salbutamol in
healthy participants delivered via an MDI containing propellant HFA-152a, and
to compare to an MDI containing propellant HFA-134a
Pharmacodynamics (PD): To characterise the PD of single doses of salbutamol in
healthy participants delivered via an MDI containing propellant HFA-152a, and
to compare to an MDI containing propellant HFA-134a
Safety: To characterise the safety and tolerability of single doses of
salbutamol in healthy participants delivered via an MDI containing propellant
HFA-152a, and to compare to an MDI containing propellant HFA-134a
Background summary
Salbutamol is an approved drug that is currently used for the treatment of
asthma. Asthma is a disease where the airways are narrow because of
inflammation and tightening of the muscles in the lungs. This results in
breathing difficulties such as shortness of breath. Salbutamol causes the
muscles in the lungs to relax, thereby opening the airways and relieving and
preventing asthma symptoms.
Study objective
Certain drugs are administered by using an inhaler (puffs). An inhaler may
contain propellant to get the right amount of the medicine into the lungs in
the right way. Some of the propellants used in inhalers are greenhouse gasses
and are therefore bad for the environment. This is for example the case for the
propellant that is used for the inhalation (breathing in) of salbutamol, which
is the main ingredient of the asthma product called Ventolin Evohaler®. The
sponsor is therefore now testing an alternative propellant that is less harmful
for the environment.
To test whether the alternative propellant works as well as the original
propellant, we will compare the salbutamol blood levels when the different
propellants are used.
We will also investigate the safety and tolerability of salbutamol when it is
administered to healthy subjects with the inhaler with the different
propellants.
Salbutamol is not a new compound; it is already being used by patients with
asthma and has been on the market internationally since 1968.
Study design
The study will take a maximum of 33 days from the screening until the follow-up.
In total the volunteer will come to the research center 2 times:
- once for the screening.
- once for a stay in the research center of 6 days (5 nights).
The study compound salbutamol will be given with an inhaler, using different
propellants. They will receive salbutamol once with the original propellant and
once with the alternative propellant. The order in which they will receive them
will be determined by drawing lots. Neither the volunteer nor the responsible
doctor will know in which order the volunteer will get them. This is to ensure
that the results of each study treatment are treated in the same way.
The study compound will be given after the breakfast. After administration of
the study compound, the volunteer has to fast (not eat and drink, except water)
for 4 hours.
On the day the volunteer enters the research center, the volunteer will receive
training on how to use the inhaler.
Intervention
A study treatment will be given on Day 1, and Day 4. Each time the volunteer
will receive a dose of 800 microgram of salbutamol. This will be given by
inhaling 8 puffs of 100 microgram each with 20 seconds between each puff.
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula (a tube in a vein in the arm) can sometimes lead to inflammation,
swelling, hardening of the vein, blood clotting, and bleeding in the
environment (bruising) of the puncture site. In some individuals, a blood draw
can sometimes cause pallor, nausea, sweating, low heart rate, or drop in blood
pressure with dizziness or fainting.
In total, we will take about 314 milliliters (mL) of blood from the volunteer
from screening to follow-up. This amount does not cause any problems in adults.
To compare: a blood donation involves 500 mL of blood being taken each time at
once. If the investigator thinks it is necessary for the safety of a subject,
extra blood samples might be taken for possible additional testing. If this
happens, the total amount of blood drawn may be more than the amount indicated
above.
Heart tracing
To make a heart tracing, electrodes (small, plastic patches) will be placed on
the volunteers arms, chest and legs. Prolonged use of these electrodes can
cause skin irritation (rash and itching).
Coronavirus test
Samples for the coronavirus test will be taken from the back of the volunteers
nose and throat using swabs. Taking the samples only takes a few seconds, but
can cause discomfort and can give an unpleasant feeling. Taking a sample from
the back of the volunteers throat may cause the volunteer to gag. When the
sample is taken from the back of the volunteers nose, the volunteer may
experience a stinging sensation and the volunteers eyes may become watery.
Inhaler
For each dose, the volunteer will be asked to take 8 puffs (inhalations) of
salbutamol in quick succession. There is a chance that taking multiple deep
breaths may cause some individuals to feel dizzy or lightheaded, and feel
numbness or tingling in their hands or around their mouth. This is usually
harmless, and usually stops after you breathe normally for a while.
Great West Road 980
Brentford, Middlesex TW8 9GS
GB
Great West Road 980
Brentford, Middlesex TW8 9GS
GB
Listed location countries
Age
Inclusion criteria
1.Sex: male or female; females may be of childbearing potential, of
nonchildbearing potential, or postmenopausal
2. Age : 18 to 50 years, inclusive, at screening
3. BMI : 18.0 to 30.0 kg/m2, inclusive, at screening
4. Weight : >=50 kg
5. Status : healthy participants
Further criteria apply
Exclusion criteria
1. History or presence of cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematologic, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs;
constituting a risk when taking the study intervention or interfering with the
interpretation of data.
2. History or presence of any form of asthma, including childhood asthma and
exercise induced asthma.
3. Systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure
<50 mmHg or >90 mmHg.
4. History of pathological tachycardia, or a pulse rate > 85 bpm at screening
or Day -1.
5. Lymphoma, leukemia, or any malignancy within the past 5 years except for
basal cell or squamous epithelial carcinomas of the skin that have been
resected with no evidence of metastatic disease for 3 years.
Further criteria apply
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-003406-77-NL |
| CCMO | NL83151.056.22 |