Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of Beclometasone Dipropionate in Patients with Asthma to Evaluate Disease Characteristics and Control

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study looks at people with Asthma, a condition that makes breathing difficult because the airways become narrow and inflamed. The medication being used is an inhaled steroid called beclometasone dipropionate that is taken by inhalation to reduce airway swelling and improve breathing.

The aim is to describe how different patients experience the disease, how well their symptoms are controlled, and how the medicine and other treatments are used over time. Participants will be asked to attend regular visits where information about their health, use of inhalers, and any flare‑ups will be recorded, and simple breathing tests will be done to check changes in lung function. Blood or breath samples will also be collected to measure biomarkers that indicate the level of airway inflammation.

Over the study period, people will complete questionnaires about daily activities, sleep, and how asthma affects work or school, and doctors will note any visits to emergency services or hospitals. The collected data will help understand the relationship between the measured inflammation markers and the way symptoms change, without requiring any experimental procedures beyond routine care.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    You attend the first study visit after joining the trial.

    You complete a questionnaire that records your asthma history, current symptoms, and quality of life.

    Your current asthma medications are documented.

  2. Step 2

    Start inhaled medication

    You begin using beclomethasone for inhalation at the dose specified in the study protocol (9999 µg).

    The frequency and duration of use are provided by the study staff.

  3. Step 3

    Regular asthma control assessments

    At scheduled intervals you complete a short questionnaire about your asthma control, such as frequency of symptoms and need for rescue medication.

    The information helps track changes in your asthma over time.

  4. Step 4

    Lung function testing

    During each follow‑up visit you perform a lung function test that measures how well you can breathe.

    The results are compared with previous tests to monitor any changes.

  5. Step 5

    Biomarker sampling

    You may provide a small blood or breath sample at certain visits to measure biomarker levels related to type‑2 inflammation.

    These measurements are used to classify participants into high or low type‑2 groups.

  6. Step 6

    Final visit and study completion

    At the end of the study period you attend a final visit.

    You repeat the questionnaire, lung function test, and biomarker sampling.

    All collected data are used to evaluate long‑term asthma control and treatment patterns.

Who can join the trial?

6 criteria

  • Be at least 6 years old to join the first part of the study.
  • Be at least 18 years old to join the second part of the study.
  • Have a doctor’s diagnosis of asthma that has lasted for at least 12 months.
  • Currently be taking an inhaled corticosteroid (ICS) medication at a low, medium, or high dose (for the first part) or at a low or medium dose (for the second part) as recommended by the GINA treatment steps (a set of guidelines that describe how asthma medicines are stepped up or down).
  • Give your permission (or have a legal representative give permission) to take part in the study.
  • For the second part of the study, you must meet at least one of these conditions: an Asthma Control Questionnaire‑5 (ACQ‑5) score of 1.5 or higher (meaning asthma is not well controlled), an ACQ‑5 score below 1.5 (meaning asthma is well controlled), elevated Type‑2 (T2) biomarkers (a sign of “type‑2‑high” asthma), or low T2 biomarkers (a sign of “type‑2‑low” asthma). The ACQ‑5 is a short questionnaire that asks about your asthma symptoms, and the T2 biomarkers are substances measured in blood that reflect a certain type of airway inflammation.

Who cannot join the trial?

5 criteria

  • Having a current diagnosis of chronic obstructive pulmonary disease (COPD) – a long‑term lung condition that makes breathing difficult – or congestive heart failure, which means the heart cannot pump blood as well as it should.
  • Having moderate or severe cognitive impairment, meaning problems with thinking, memory, or understanding that affect daily life.
  • Having moderate or severe cardiac disease, which refers to serious problems with the heart’s structure or function.
  • Taking immunosuppressive medication for a long‑term condition; these drugs lower the body’s ability to fight infections.
  • Being involved in another clinical study, whether it is an interventional (testing a new treatment) or noninterventional (observing without changing treatment) study, either right now or within the past three months.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Beclomethasone is an inhaled steroid used in the study to reduce inflammation in the airways of people with asthma. Participants will breathe the medication through a device, which helps keep the airways open and can lower the frequency of asthma attacks. The trial will examine how well this treatment works in real‑world patients with different levels of disease severity and control.

What is already known about the treatment

Beclometasone dipropionate - It is inhaled as a spray that patients breathe in, delivering the medicine directly to the lungs. The drug is an established inhaled corticosteroid that is widely used and studied for asthma treatment. It works by reducing swelling and irritation in the airways, helping them stay open more easily. It belongs to the class of corticosteroid anti‑inflammatory agents.

Investigated diseases

Asthma - Asthma is a chronic condition that causes the airways to become narrow and inflamed, making breathing difficult. People with asthma experience recurring episodes of wheezing, coughing, shortness of breath, and chest tightness. These episodes can vary in frequency and intensity over time. The underlying airway changes can become more persistent, leading to increased sensitivity to triggers such as allergens, cold air, or exercise. Over months to years, some individuals notice a gradual worsening of symptoms if the disease is not well managed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524916-13-00Protocol codePIR21191Estimated enrolment2 500 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.