A 52-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLEDUMMY, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY OF FEVIPIPRANT ONCE DAILY PLUS STANDARD-OF-CARE (SOC) FORREDUCTION OF SYSTEMIC CORTICOSTEROIDS (ORAL AND PARENTERAL) USE IN PATIENTS WITH SEVERE ASTHMA
- Conditions
- -J45J45
- Registration Number
- PER-050-18
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 17
1. Signed informed consent.
2. Male and female patients ≥18 years
3. Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening
Visit with current asthma severity step 4 or 5 (GINA 2018)
4. Currently on treatment with medium or high dose ICS/LABA +/- other controller for a minimum of 6 weeks prior to Screening Visit.
5. At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-InVisit .
6. An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility is accepted).
7. Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit.
8. Documented history of at least 1 asthma within 1 year prior to enrolment.
1. Asthma exacerbation, within 6 weeks prior to enrolment that required SCS, hospitalization, or emergency room visit.
2. Chronic/ maintenance use of OCS for asthma.
3. Prior use of biologics.
4. Any contra-indications of SCS use.
5. Pregnant or nursing (lactating) women.
6. Women of child-bearing potential, unless they are using methods of
7. Use of other investigational drugs.
8. Hypersensitivity to any of the study drugs.
9. History of malignancy of any organ system.
10. Patients who have smoked or inhaled any substance other than asthma medications
11. Patients requiring SCS use for conditions other than asthma
12. Patients with a history of chronic lung disease other than asthma,sarcoidosis, interstitial lung disease, cystic fibrosis, and active tuberculosis
13. Patients with history of alcohol or drug abuse
14. Patients with a known history of non-compliance to medication or unable/unwilling to complete an electronic patient diary or Electronic Peak Flow with eDiary device
15. Patients who have had a respiratory tract infection or asthma worsening
16. Patients with any chronic condition of the respiratory tract
17. Patients who have a clinically significant laboratory abnormality
18. Serious co-morbidities
19. Patients receiving any prohibited medication
20. Patients who started immunotherapy or desensitization for allergies
21. Inability to comply with all study requirements and demonstrate good medication compliance
22.Any medical or psychological condition that renders the patient unable to understand the nature, scope, and possible consequences of the study
23. Patients with a history of being unable to swallow tablets
24. Patients who have received immunomodulator or immumomodulatory drugs or any experimental anti-inflammatory therapies
25. Current treatment for hepatic disease
26. History of immunodeficiency disease or hepatitis B or hepatitis C
27. Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2mg of pitavastatin
28. Patients on any statin therapy with a CK level >2 X ULN
29. Patients on rifampin, probenecid, ritonavir and valproic acid
30. No person directly associated with the administration or study site family member is allowed to participate
31. History of lactose or milk sensitivity
32. Conditions other than asthma that could result in elevated eosinophils
33. Diagnosis of ECG abnormalities indicating significant
34. Patients with a resting QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female)
35. Use of agents with known risk of TdP
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method