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.
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN17142179
- Lead Sponsor
- Chiesi (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 513
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 source documentation. ]
Previous inclusion criteria:
1. Male and female adults aged =18 and =75
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: in case the bronchodilator (BD) response threshold is not met at screening, 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, historical documentation of the BD response can be provided. Historical documentation of BD response defined according to the 2005 American Thoracic Society (ATS)/European Respiratory Society (ERS) Task Force on interpretative strategies for lung function tests, or history of positive bronchial challenge test (methacholine) within 24 months prior to screening (copy of original printed spirometry to be included as source documentation) is also accepted. ]
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 enrolment
2. 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 medicine
4. Asthma subjects currently treated with chronic SCS, anti-immunoglobulin E (IgE), or any other biologic therapy
5. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Potential for bronchoconstriction of each study treatment, defined as the relative change from pre-dose in FEV1 at the 10 min post-dose timepoint on Day 1
- Secondary Outcome Measures
Name Time Method