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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Intercommunal Creteil Creteil France
Klinikum der Universitaet Muenchen AöR Munich Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Hopital Europeen Marseille Marseille France
Oncopole Claudius Regaud Toulouse France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
CHU Grenoble Alpes La Tronche France
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Hospital Vall d’Hebron Barcelona Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitario Lucus Augusti Lugo Spain
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario De La Princesa Madrid Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Hospital San Pedro De Alcantara Caceres Spain
Hospital Universitario Infanta Leonor Madrid Spain
Hospital Quironsalud Malaga Malaga Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
IRCCS Humanitas Research Hospital Rozzano Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
ASST Fatebenefratelli Sacco Milan Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Universita Degli Studi Di Brescia Brescia Italy
University Magna Graecia Of Catanzaro Catanzaro Italy

Other Sites

Site Name City Country Status
Clinique Via Domitia Lunel France
Allergie-und Asthmastudienzentrum Bonn Germany
Hospital Universitario San Juan De Alicante Sant Joan D'alacant Spain
Pectus Respiratory Health Girona Girona Spain
Csynci Hpredbzzsnw Dy Cmrluu Sjdjup Vxhc Cannes France
Mkyglceh Grrm Frankfurt Germany
Lwadbywqdfbf Bqau Bonn Germany
Pclwqisikbxjzyaoyw Wdsmmslbdxjzijmkk Gud Hohenstein-Ernstthal Germany
Pludgambhcx Osnkrwjqmzz Munich Germany
Lklpwavmmkysrbac Hgatxetyzek Berlin Germany
Snhqwzdrc Gmxx Hanover Germany
Hurcodr Dluvjsqhfahjvqdttar Dwl Anlfcv Pfmue Clamart France
Hnvngaus Vfqpro Xnvyb Ilktzhumbucmy Benalmadena Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
09.10.2026
Germany Germany
Not yet recruiting
09.10.2026
Italy Italy
Not yet recruiting
09.10.2026
Spain Spain
Not yet recruiting
09.10.2026

Trial locations

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.

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 ID:
2025-524916-13-00
Protocol code:
PIR21191
NCT ID:
NCT07556159
Trial Phase:
Therapeutic confirmatory (Phase III)

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