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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Dave Singh
-
DSingh@meu.org.uk


Dr Selene Parenti
+39 3665759430
Selene.Parenti@clinchoice.com


Dr Global Clinical Development Chiesi Farmaceutici Spa
-
clinicaltrials_info@chiesi.com


Study Location:

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Be Part of Research - Trial Details - A clinical trial, involving several sites in several countries, with a duration of 12 weeks, where patients, medical doctors and the sponsor do not know the treatment taken by the patient (between one study treatment and another one) with the scope of evaluating the safety of study treatment in comparison with another similar one in subjects with asthma.
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A clinical trial, involving several sites in several countries, with a duration of 12 weeks, where patients, medical doctors and the sponsor do not know the treatment taken by the patient (between one study treatment and another one) with the scope of evaluating the safety of study treatment in comparison with another similar one in subjects with asthma.

Recruiting

Open to: All Genders

Age: Mixed

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Medical Conditions

Asthma

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a clinical trial, involving several sites in several countries, with a duration of 12 weeks, where patients, medical doctors and the sponsor do not know the treatment taken by the patient (between one study treatment and another one) with the scope of evaluating the safety of study treatment in comparison with another similar one in subjects with asthma.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Nov 2023 30 Nov 2024

Not provided at time of registration


Patients aged between 18 and 75 years old with asthma

You can take part if:


Current inclusion criteria as of 10/05/2024:
1. Male and female adults aged ≥18 and ≤75 years
2. Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2
3. Physician-diagnosed asthma >6 months and diagnosis before 50 years
4. Stable asthma therapy: a stable treatment with medium/high doses of ICS+LABA+LAMA (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening
5. Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire (ACQ-7) score <1.5 at screening and at randomization;
6. Pre-bronchodilator 40% < FEV1 < 90% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization;
7. Subjects with a positive reversibility test at screening defined as an increase ≥ 12% and/or 200 mL within 15-20 minutes after inhalation of 400mcg salbutamol [ Note 1: To assess for BD response, pre-BD and post-BD spirometry must meet the acceptability and repeatability criteria as reported in the 2019 ATS/ERS Standardisation of Spirometry Update. Note 2: In case the BD response threshold is not met at a screening or if spirometry does not meet quality requirements, the spirometry test can be repeated no later than 1 day before randomisation at a second spirometry visit. In case the BD response is not met at this second spirometry visit or if spirometry does not meet quality requirements, historical documentation of BD response can be provided. Historical documentation of BD response, defined according to the 2005 American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines or history of positive bronchial challenge test (methacholine) within 24 months prior to screening, is also accepted. Copy of original printed spirometry or bronchial challenge test must be included as sour


You may not be able to take part if:


1. History of near-fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment2. Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation)3. Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine4. Asthma subjects currently treated with chronic SCS, anti-immunoglobulin E (IgE), or any other biologic therapy5. Any concomitant respiratory disease that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the investigational product or interpretation of subject safety or study results. This can include but is not limited to the diagnosis of chronic obstructive pulmonary disease (COPD) as defined by the current guidelines


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Propellant HFA-152a: Changes in your ability to feel the taste, Coughing, Dysphonia (voice impairment), Wheezing, or shortness of breath in case of narrowing of the airways (bronchoconstriction). These potential side effects are expected to be rapidly reversible and mild. The study doctor will administer rescue medications to resolve discomfort if deemed necessary.
Common: urinary tract infection, inflammation of the back of the throat, oral fungal infection, runny or stuffy nose, sneezing, sore throat, headache and voice alteration (hoarseness).
Uncommon: flulike symptoms, trembling, dizziness, inflammation of the ear, irregular heartbeat, changes in the electrocardiogram (ECG), unusual fast heartbeat, feeling your heartbeat, increase of blood flow to certain tissues in the body, high blood pressure, throat irritation, oral fungal infection, oesophageal thrush, inflammation of the paranasal sinuses, irritation and inflammation of the mucous membrane inside the nose, vaginal thrush, diarrhoea, dry mouth, difficulty swallowing, nausea, stomach discomfort after meals, burning sensation of the lips, abnormal or reduced sense of taste, numbness, cough and productive cough, nose bleeds, dental caries, mouth inflammation (stomatitis), allergic inflammation of the skin, rash, hives, itching, excessive sweating, muscle spasms, pain in arms or legs, pain in muscles, bones or joints of the chest, restlessness, tiredness, weakness, changes in blood components (decrease in white blood cells, increase in platelets, decrease of potassium, increase of sugar level, increase of insulin level, increase of fatty acids, increase of ketones, increase of C-reactive protein, decrease of cortisol level in blood).
Rare: fungal infections of the chest, hypersensitivity reactions including erythema, lips, face, eye and pharyngeal oedema, decreased appetite, sleep disorders (sleeping too little or too long), crushing chest pain, unusually slow heartbeats, leakage of blood from a vessel into the tissues surrounding it, asthma exacerbation, pain in the back of the mouth and throat, dry throat, inflammation and redness of the pharynx, inflammation of the kidneys, painful and frequent urination, difficulty and pain when passing urine, weakness, increase or decrease in blood pressure.
Very rare: Glaucoma (an eye disease causing damage to the optic nerve), cataract (a cloudy area in the lens of the eye that leads to a decrease in vision), feeling breathless or short of breath, swelling of the hands and feet, bone density decreased, low level in the number of certain blood cells called platelets, inadequate production of cortisol. Side effects with unknown frequency: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (predominantly in children), and blurred vision.
Rescue medication can be used.

Dr Global Clinical Development Chiesi Farmaceutici Spa
-
clinicaltrials_info@chiesi.com


Dr Dave Singh
-
DSingh@meu.org.uk


Dr Selene Parenti
+39 3665759430
Selene.Parenti@clinchoice.com



The study is sponsored by Chiesi (Italy) and funded by Chiesi Farmaceutici.



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Read full details for Trial ID: ISRCTN17142179

Or CPMS 56827

Last updated 22 August 2024

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