Severe eosinophilic asthma MedDRA version: 21.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Provision of informed consent prior to any study-specific procedures 2 Patient must be aged 18 years old or above at the time of consenting to study participation 3 Documented current maintenance treatment with high-dose ICS/LABA 4 ACQ-5 score 8 weeks) prior to Visit 1 6 Male or female 7 Negative serum pregnancy test at Visit 1 for women of childbearing potential (WOCBP) 8 WOCBP must agree to use a highly effective method of birth control (confirmed by the Investigator) from randomisation throughout the study duration and within 12 weeks after the last dose of study treatment. Highly effective forms of birth control (those that can achieve a failure rate of less than 1% per year when used consistently and correctly) include: - Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation-oral, intravaginal, or transdermal - Progestogen-only hormonal contraception associated with inhibition of ovulation-oral, injectable, or implantable - Intrauterine device (IUD) - Intrauterine hormone-releasing system (IUS) - Bilateral tubal occlusion - Sexual abstinence, ie, refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient) - Vasectomised sexual partner (provided that partner is the sole sexual partner of the WOCBP study patient and that the vasectomised partner has received medical assessment of the surgical success) Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal Women will be considered postmenopausal if they have been amenorrhoeic for =12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply: - Women =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 As judged by the Investigator, any evidence of a severe or serious treatment-related AE during Fasenra® treatment which in the Investigator’s opinion makes it undesirable for the patient to participate in the study 2 History of exacerbation requiring systemic corticosteroids or hospitalisation during the last 3 months prior to Visit 1 or during the run-in period 3 Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome) 4 Current smokers or former smokers with a smoking history =20 pack/years 5 History of alcohol or drug abuse within 12 months prior to Visit 1 6 A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy 7 History of anaphylaxis to any biologic therapy 8 Known history of allergy or reaction to any component of the study treatment formulation 9 A history of known immunodeficiency disorder, including history of a positive human immunodeficiency virus (HIV) test 10 Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the potential for Fasenra® - treated patients to reduce Symbicort® maintenance treatment while maintaining asthma symptom control;Secondary Objective: - To assess changes in patient-reported outcomes for Fasenra® -treated patients while stepping down Symbicort® maintenance treatment - To assess the potential for Fasenra® - treated patients to maintain lung function while stepping down Symbicort® maintenance treatment - To assess asthma exacerbation rate - To assess the total ICS dose exposure - To assess if reductions in Symbicort® maintenance achieved at the end of the reduction period are maintained until the end of the maintenance period;Primary end point(s): Proportion of patients who reduced their Symbicort® maintenance dose at the end of the reduction period (Week 32) to: - Medium-dose Symbicort® maintenance and reliever therapy (SMART), or - Low-dose SMART, or - Symbicort® anti-inflammatory reliever only;Timepoint(s) of evaluation of this end point: Refer section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in ACQ-5 score at the end of the reduction period - Change from baseline in AQLQ(S)+12 at the end of the reduction period - Proportion of patients with no deterioration in AQLQ(S)+12 (deterioration defined as a decrease of at least 0.5 units compared to baseline) at the end of the reduction period - Proportion of patients with no deterioration in ACQ-5 (deterioration defined as an increase of at least 0.5 units compared to baseline) at the end of the reduction period - Change from baseline in pre-bronchodilator FEV1during the study period - Annualised asthma exacerbation rate during the study period - Cumulative total daily ICS dose (maintenance + reliever) for: o The reduction period o The maintenance period o The study period - Total daily ICS dose (maintenance + reliever) at the end of the reduction period - Proportion of patients using the same Symbicort® daily dose at the end of the maintenance period (Week 48) that they achieved at the end of the reduction period (Week 32) - Supportive outcomes: o Number of exacerbations occurring from end of the reduction period to end of the maintenance period o Total daily ICS dose from the end of the reduction period to the end of the maintenance period o Change in ACQ-5, AQLQ(S)+12, and FEV1from the end of the reduction period to the end of the maintenance period;Timepoint(s) of evaluation of this end point: Refer section E.5.2 | — |
Countries
France, Germany, United Kingdom
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed