Not recruiting

Evaluation of lung delivery and systemic exposure of inhaled beclometasone dipropionate and beclometasone dipropionate anhydrous for asthma in healthy adult volunteers

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study involves people with asthma, a condition that makes the airways narrow and can cause wheezing, coughing, and shortness of breath. The medication being tested is an inhaled steroid called beclometasone dipropionate, which is delivered through a press‑urized metered‑dose inhaler (pMDI). The inhaler used in the trial is identified as CHF 718 pMDI HFA-152a and is compared with a similar device that uses a different propellant. Both inhalers are used together with a Volumatic® spacer, a plastic tube that helps the medicine reach the lungs more effectively. The drug is broken down in the body to an active form called beclometasone 17-monoproprionate, which also contributes to the treatment effect.

The purpose of the study is to evaluate how much of the medication reaches the lungs and how much enters the bloodstream. In this phase I trial, healthy adult volunteers receive a single dose of one inhaler, then after a short break they receive a dose of the other inhaler in a “crossover” design, meaning each participant tries both devices. Blood samples are taken after each dose to measure the drug and its active breakdown product, and the timing of these samples follows a simple schedule. The study does not involve any long‑term treatment, and participants are monitored only for a short period after each inhalation.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and assignment
After you join the study, you are randomly assigned to receive either the test inhaler (using the hfa-152a propellant) or the comparator inhaler (using the hfa-134a propellant). the study is double‑blind, so you will not know which inhaler you receive.
The assignment is recorded by the study team, and you will be given a pressurised metered dose inhaler (pmdi) together with a volumatic® spacer.
Step 2
First dosing session
On the scheduled day, you will use the spacer that was provided. attach the inhaler to the spacer, shake it gently, and then breathe out fully.
You will take four inhalations. each inhalation delivers 200 µg of beclometasone dipropionate, for a total dose of 800 µg. after each inhalation, you will hold your breath for a few seconds before exhaling.
The inhalation is performed under observation, and the study staff may collect blood samples at specific times to measure how the medicine is absorbed.
Step 3
Monitoring after first dose
Following the inhalations, you will remain in the clinic for several hours while the study staff checks for any immediate reactions and collects additional blood samples as required by the protocol.
Step 4
Washout period
After the monitoring period, you will have a washout period. this break allows the drug to leave your body completely before the next dosing session. the length of the washout period is determined by the study protocol.
Step 5
Second dosing session (crossover)
After the washout period, you will receive the other inhaler that you did not use in the first session. the same procedure is followed: attach the inhaler to the volumatic® spacer, shake, exhale fully, and then take four inhalations of 200 µg each, for a total of 800 µg of beclometasone dipropionate.
The inhalations are again observed, and blood samples are taken at the same time points as in the first session.
Step 6
Monitoring after second dose
You will stay in the clinic for several hours after the second set of inhalations, during which the study staff monitors you and collects the required blood samples.
Step 7
Study completion
Once all samples have been collected and the observation periods are finished, your participation in the study is complete. no further study‑related procedures are required.

Who can join the trial?

10 criteria

Provide written informed consent before any study procedures begin.
Women must be either unable to become pregnant (post‑menopausal or permanently sterile) or, if they could become pregnant, must have either a fertile male partner who agrees to use a highly effective birth‑control method, or a non‑fertile male partner (no birth control needed).
Be a healthy male or female aged between 18 and 55 years.
Be able to understand what will happen in the study, the possible risks, and be able to be trained to use the inhaler correctly; the training must be completed successfully.
Have a body mass index (BMI) between 19.0 and 30.0 kg/m² (inclusive) and weigh at least 50 kg.
Be a non‑smoker, or an ex‑smoker who smoked less than 5 pack‑years (one pack per day for one year equals one pack‑year) and stopped smoking at least one year before screening.
Show good overall physical and mental health based on medical history and a general clinical exam.
Have normal vital signs at screening: diastolic blood pressure 40‑90 mmHg, systolic blood pressure 90‑140 mmHg, and body temperature below 37.5 °C.
Have a normal 12‑lead electrocardiogram (ECG) at screening, meaning a heart rate between 40‑110 beats per minute, PR interval 120‑220 ms, QRS duration ≤120 ms, and a corrected QT interval (QTcF) ≤450 ms for men or ≤470 ms for women.
Have normal lung function at screening: a ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) greater than 0.70, and an FEV1 that is at least 80 % of the predicted value for the person’s age, sex, and size.

Who cannot join the trial?

10 criteria

You must not have taken part in another clinical study using a new investigational drug within the past 30 days, or longer if the drug stays in your body for a long time (five half‑life periods, which is the time it takes for half of the drug to be cleared).
A urine test that shows the presence of cotinine (a substance that indicates recent tobacco use) will exclude you.
You cannot have any serious or uncontrolled health problems that affect breathing (respiratory), the heart (cardiac), the liver (hepatic), the stomach or intestines (gastrointestinal), the kidneys (renal), hormones (endocrine), metabolism (metabolic), nerves (neurologic) or mental health (psychiatric) because they could interfere with the study.
If your screening tests (blood, urine, etc.) show abnormal laboratory values that suggest an unknown disease or could affect safety or study results, you will be excluded.
Anyone with a history of significant breathing problems, such as asthma (including childhood asthma), cannot take part.
A positive blood test for HIV (human immunodeficiency virus) 1 or 2 will disqualify you.
Positive tests showing current or past infection with hepatitis B or hepatitis C (liver viruses) will exclude you.
If you have been diagnosed with COVID‑19 in the last two weeks, still have related symptoms, or test positive for COVID‑19 on the first day of treatment without an official recovery certificate, you cannot participate.
You must not have donated a large amount of blood (about 450 mL, roughly one pint) or experienced a similar loss of blood within the two months before screening.
Your blood must have normal hemoglobin levels (the protein that carries oxygen). This means hemoglobin must be at least 11.0 g/dL for women and 12.9 g/dL for men; lower values will exclude you.

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Investigated drugs

Beclometasone dipropionate
is an inhaled steroid that reduces inflammation in the lungs. In this study it is given as a pressurised inhaler using a new propellant (HFA‑152a). Participants inhale four doses through a Volumatic® spacer, which helps the medicine reach the lungs more effectively. The trial measures how much of the drug gets into the lungs and how much enters the bloodstream.
Clenil Modulite
is a well‑known inhaled steroid that also contains beclometasone dipropionate (anhydrous form). It is delivered with a standard propellant (HFA‑134a) in a pressurised inhaler. Like the test product, it is used with a Volumatic® spacer, and the study compares its lung delivery and overall exposure to that of the new formulation.

What is already known about the treatment

BECLOMETASONE DIPROPIONATE
It is inhaled from a pressurised metered‑dose inhaler as a liquid solution; beclometasone dipropionate is an approved inhaled corticosteroid that has been used for many years to treat asthma; it works by lowering swelling and irritation in the airways so breathing becomes easier; it is classified as an inhaled corticosteroid.
Clenil Modulite 200 micrograms per metered dose Pressurised Inhalation Solution
It is also inhaled from a pressurised metered‑dose inhaler as a liquid solution; this product contains beclometasone dipropionate anhydrous, an approved inhaled corticosteroid commonly used for asthma; it reduces airway swelling and irritation, helping the lungs stay open; it belongs to the inhaled corticosteroid class.

Investigated diseases

Asthma - Asthma is a chronic condition in which the airways become inflamed and overly sensitive, leading to episodes of wheezing, coughing, shortness of breath, and chest tightness. Over time, the airway inflammation can cause the airways to become more narrowed and less responsive, resulting in increasingly frequent or severe episodes, especially when triggered by allergens, exercise, or infections.