Asthma; EosinophilicPhase 3PERSEANCT04049175
Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma
A Phase 3 study testing Treatment A, Treatment B and Treatment C in people with Asthma; Eosinophilic, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
The purpose of this phase III Study is to demonstrate the efficacy of at least one dose of CHF 6532 on moderate and severe asthma exacerbations rate compared to placebo. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma; Eosinophilic
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 1 siteBulgaria
- Study dates
- 28 Aug 2019to 1 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥12 years and ≤75 years with a diagnosis of asthma [according to Global Initiative for Asthma (GINA)] for a period of at least 24 months prior to screening.
- Subjects treated according to GINA step 4/5 with stable high-dose inhaled corticosteroids (ICS) plus a long-acting β2 agonist (LABA)
- 2 Asthma exacerbations history.
- A positive response to a reversibility test at screening.
- Subjects with evidenced eosinophilic airway inflammation at screening visit.
- Subjects with uncontrolled asthma as evidenced by ACQ-5 score ≥1.5 at screening and randomisation visits.
- Subjects with co-operative attitude and ability to perform all trial related procedures.
- Ability of patient to swallow tablets.
Who cannot join
- Pregnant or lactating women and all women of childbearing potential unless are using a highly effective birth control method.
- Run-in compliance < 50% at randomisation
- Hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks prior to screening visit or during the run-in period.
- Subjects with a history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the investigator, may place the subjects at undue risk.
- Subjects with a history of more than 2 episodes of confirmed bacterial lower respiratory tract infection within the year prior to screening or with a bacterial lower respiratory tract infection during the run-in.
- History of diagnosis of Chronic Obstructive Pulmonary Disease (COPD), cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
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- Subjects with a marked resting baseline prolongation of mean QTc interval.
- Subjects with a family history of long QT Syndrome.
- Subjects with hypokalemia at screening.
- Subjects who have known clinically significant cardiovascular conditions.
- Subjects with a history of symptoms or significant neurological disease.
- Subjects with clinically significant abnormal serum biochemistry, haematology (not associated with the study indication) at screening according to the investigators judgement.
- Current smokers or ex-smokers with total cumulative exposure ≥10 pack-years or having stopped smoking less than one year prior to screening visit.
- Subjects with historical or current evidence of uncontrolled concurrent disease.
- Subjects with a history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity within the previous 3 months before the screening visit.
- Subjects receiving treatment with one or more drugs listed in the prohibited medication section.
- Regular use of oral or systemic corticosteroids for diseases other than asthma within the past 12 months or any intra-articular or short-acting, intramuscular corticosteroid within 1 month or intramuscular, long-acting depot corticosteroids within 3 months prior to screening.
- Subjects with severe hepatitis chronic active hepatitis or evidence of uncontrolled chronic liver disease.
- Subjects with Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) at screening ≥2x Upper Limit of Normal.
- Subjects with other severe acute or chronic medical or malignancy or psychiatric conditions which are uncontrolled or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, would make the subjects inappropriate for entry into this study.
- Subjects with a history of lung volume resection.
- Subjects with a diagnosis of lung cancer or a history of lung cancer.
- Subjects with active cancer or a history of cancer (other than lung) with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localised carcinoma (e.g. basal cell carcinoma, in situ carcinoma of the cervix adequately treated) is acceptable.
- Subjects who have received an investigational drug within 30 days (60 days for biologics) or five half-lives (whichever is greater) prior to screening visit.
- Subjects with a history of alcohol or drug abuse within two years prior to screening visit.
- Subjects with major surgery in the 3 months prior to screening visit or planned surgery during the trial.
- Subjects mentally or legally incapacitated or subjects accommodated in an establishment as a result of an official or judicial order.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical Center "Nov Rehabilitatsionen Tsentar" Ltd
Stara Zagora, 6000
About this study
Official title: A 52 Week, Randomised, Double Blind, Multinational, Multicentre, 4-arm Parallel Group Trial to Assess the Efficacy and Safety of 3 Doses of CHF 6532 Compared to Placebo on Top of Standard of Care in Patients With Uncontrolled Severe Eosinophilic Asthma
The purpose of this phase III Study is to demonstrate the efficacy of at least one dose of CHF 6532 on moderate and severe asthma exacerbations rate compared to placebo.
Read the detailed description
This is a phase III, randomised, double-blind, placebo controlled multinational, multicentre, 4-arm parallel-group, study evaluating 3 doses of CHF 6532.
The effect of CHF 6532 compared to Placebo on severe asthma exacerbations over 52 weeks of treatment will be assessed.
The effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning Forced Expiratory Volume in the first second (FEV1) as well as on St. George's Respiratory Questionnaire (SGRQ), Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ+12), at Week 52 will be assessed .
The inter-subject variability in the drug exposure and the effect of selected covariates on Pharmacokinetics (PK) will be investigated.
The impact of study treatments on health economics outcomes will be also investigated.
Standard safety assessments will be conducted during the Study, including electrocardiograms (ECGs), vital signs and laboratory tests.
Approximately 1392 severe eosinophilic asthmatic adult subjects and additional 248 severe eosinophilic asthmatic adolescent subjects will be randomised in about 150 investigational sites.
- Conditions
- Asthma; Eosinophilic
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Also called CHF 6532
Tablet of CHF 6532
Treatment BDrug
Also called CHF 6532
Tablet of CHF 6532
Treatment CDrug
Also called CHF 6532
Tablet of CHF 6532
Treatment DDrug
Also called CHF 6532
Tablet of CHF 6532 placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Administration of CHF 6532 Dose #1 Receives: Drug: Treatment A |
| Treatment B | Experimental | Administration of CHF 6532 Dose #2 Receives: Drug: Treatment B |
| Treatment C | Experimental | Administration of CHF 6532 Dose #3 Receives: Drug: Treatment C |
| Treatment D | Placebo comparator | Administration of CHF 6532 Placebo Receives: Drug: Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate
Rate of moderate and severe asthma exacerbations during the treatment period with CH 6532 (3 doses tested) or Placebo
Measured: Over 52 weeks of treatment
Secondary outcomes (9)
Effect of CHF 6532 on severe asthma exacerbations compared to Placebo
Assessment of time to first moderate or severe exacerbation, and of time to first severe exacerbation
Measured: Over 52 weeks of treatment
Effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning FEV1 (Forced Expiratory Volume in 1 second)
Assessment of change from Baseline in pre-dose FEV1
Measured: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on St. George's Respiratory Questionnaire (SGRQ)
Assessment of change from Baseline in SGRQ scores (Score range from 0 to 100, with lower scores corresponding to better health)
Measured: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Control Questionnaire (ACQ-5)
Assessment of change from Baseline in ACQ-5 scores (Score range from 0=no impairment to 6= maximum impairment)
Measured: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Quality of Life Questionnaire (AQLQ+12)
Assessment of change from Baseline in AQLQ+12 scores (Score range from 1=severe impairment to 7= no impairment)
Measured: At Week 52
Pharmacokinetic analysis of CHF 6532
Assessment of the area Under of the plasma concentration-time curve from 0 to the last quantifiable concentration (AUC0-t) of CHF 6532
Measured: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the area Under of the plasma concentration versus time curve observed from time 0 up to 8 hours post-dose (AUC0-8h) of CHF 6532
Measured: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the value of the maximum plasma concentration (Cmax) of CHF 6532
Measured: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the time of the maximum plasma concentration (tmax) of CHF 6532
Measured: At baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start28 Aug 2019
- Primary completion19 Oct 2020
- Study completion1 Feb 2021
Why it stopped: An interim analysis run by an independent data monitoring committee (DMC) to assess futility met the protocol-defined futility rules. The DMC recommended to stop the study for futility. The Sponsor issued a notification of early study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma; EosinophilicStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierluigi Paggiaro, MD, Principal investigator, Universita di Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049175
- Sponsor's protocol ID
- CLI-06532AA1-01
- Other IDs
- 2018-003548-22, 2018
- Acronym
- PERSEA
- Status last verified
- Mar 2022
- First submitted
- 5 Aug 2019
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52 Week, Randomised, Double Blind, Multinational, Multicentre, 4-arm Parallel Group Trial to Assess the Efficacy and Safety of 3 Doses of CHF 6532 Compared to Placebo on Top of Standard of Care in Patients With Uncontrolled Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT04049175
- Acronym / sponsor ID
- PERSEA / CLI-06532AA1-01
- Conditions
- Asthma; Eosinophilic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An interim analysis run by an independent data monitoring committee (DMC) to assess futility met the protocol-defined futility rules. The DMC recommended to stop the study for futility. The Sponsor issued a notification of early study termination.
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase III Study is to demonstrate the efficacy of at least one dose of CHF 6532 on moderate and severe asthma exacerbations rate compared to placebo.
Detailed description
This is a phase III, randomised, double-blind, placebo controlled multinational, multicentre, 4-arm parallel-group, study evaluating 3 doses of CHF 6532.
The effect of CHF 6532 compared to Placebo on severe asthma exacerbations over 52 weeks of treatment will be assessed.
The effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning Forced Expiratory Volume in the first second (FEV1) as well as on St. George's Respiratory Questionnaire (SGRQ), Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ+12), at Week 52 will be assessed .
The inter-subject variability in the drug exposure and the effect of selected covariates on Pharmacokinetics (PK) will be investigated.
The impact of study treatments on health economics outcomes will be also investigated.
Standard safety assessments will be conducted during the Study, including electrocardiograms (ECGs), vital signs and laboratory tests.
Approximately 1392 severe eosinophilic asthmatic adult subjects and additional 248 severe eosinophilic asthmatic adolescent subjects will be randomised in about 150 investigational sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Treatment AAdministration of CHF 6532 Dose #1 |
| Treatment B | Experimental | Drug: Treatment BAdministration of CHF 6532 Dose #2 |
| Treatment C | Experimental | Drug: Treatment CAdministration of CHF 6532 Dose #3 |
| Treatment D | Placebo comparator | Drug: Treatment DAdministration of CHF 6532 Placebo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥12 years and ≤75 years with a diagnosis of asthma [according to Global Initiative for Asthma (GINA)] for a period of at least 24 months prior to screening.
- Subjects treated according to GINA step 4/5 with stable high-dose inhaled corticosteroids (ICS) plus a long-acting β2 agonist (LABA)
- 2 Asthma exacerbations history.
- A positive response to a reversibility test at screening.
- Subjects with evidenced eosinophilic airway inflammation at screening visit.
Key exclusion criteria (28 listed)
- Pregnant or lactating women and all women of childbearing potential unless are using a highly effective birth control method.
- Run-in compliance < 50% at randomisation
- Hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks prior to screening visit or during the run-in period.
- Subjects with a history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the investigator, may place the subjects at undue risk.
- Subjects with a history of more than 2 episodes of confirmed bacterial lower respiratory tract infection within the year prior to screening or with a bacterial lower respiratory tract infection during the run-in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment AAlso: CHF 6532Tablet of CHF 6532 | Drug | Treatment A |
| Treatment BAlso: CHF 6532Tablet of CHF 6532 | Drug | Treatment B |
| Treatment CAlso: CHF 6532Tablet of CHF 6532 | Drug | Treatment C |
| Treatment DAlso: CHF 6532Tablet of CHF 6532 placebo | Drug | Treatment D |
Primary outcome
Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate
Time frame: Over 52 weeks of treatment
Rate of moderate and severe asthma exacerbations during the treatment period with CH 6532 (3 doses tested) or Placebo
9 secondary outcomes
Effect of CHF 6532 on severe asthma exacerbations compared to Placebo
Time frame: Over 52 weeks of treatment
Effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning FEV1 (Forced Expiratory Volume in 1 second)
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on St. George's Respiratory Questionnaire (SGRQ)
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Control Questionnaire (ACQ-5)
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Quality of Life Questionnaire (AQLQ+12)
Time frame: At Week 52
Pharmacokinetic analysis of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Time frame: At baseline and 3 months
Results and safety
The study was stopped early (reason given: An interim analysis run by an independent data monitoring committee (DMC) to assess futility met the protocol-defined futility rules. The DMC recommended to stop the study for futility. The Sponsor issued a notification of early study termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Lay Summaries of study results available in the CHIESI Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierluigi Paggiaro, MD principal investigator
Universita di Pisa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment A, Treatment B and Treatment C in people with Asthma; Eosinophilic, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: An interim analysis run by an independent data monitoring committee (DMC) to assess futility met the protocol-defined futility rules. The DMC recommended to stop the study for futility. The Sponsor issued a notification of early study termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate (time frame: Over 52 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.