Asthma
Conditions
Interventions
Trade Name: SERROFLO 25 Mikrogramm / 125 Mikrogramm / Dosis Druckgasinhalation, Suspension
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Salmeterol
CAS Number: 94749-08-
Sponsors
Cipla Europe NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confidential Cipla Ltd Page 10 of 52 ELIGIBILITY CRITERIA Inclusion Criteria: 1. Subjects willing to give voluntary signed informed consent. 2. Subjects of either sex between 18 and 65 years (both inclusive) of age. 3. Able to use investigational device appropriately. 4. Subjects should have been receiving treatment with Viani ® Evohaler 25/125 mcg for 3 months or longer and have had no change in their asthma therapy for at least 1 month prior to starting the study 5. ACQ = 1.0 6. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study. 7. Asthma diagnosis: Physician diagnosed asthma as defined by GINA 2015. 8. Subjects with current or ex-smoking history of less than 10 pack years. 9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum/urine pregnancy test, and is of non-childbearing potential, defined as: ? before menarche or ? >1 year post-menopausal or ? Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or ? Congenital sterility or ? Diagnosed as infertile and not undergoing treatment to reverse infertility or is of Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study: ? Systemic contraception used for >1 month prior to screening, including birth control pills, transdermal patch (e.g., Ortho Evra ® ), vaginal ring (e.g., NuvaRing ® ), Version No 1.0: Final Eudra CT No. 2015-004455-52 Date: 14/10/2015 Confidential Cipla Ltd Page 11 of 52 levonorgesterel (e.g., Norplant ® ), or injectable progesterone (e.g., Depo-Provera) or ? Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or ? Intrauterine device (IUD) or is of Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active 10. Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the investigator and being compliant with all study requirements (visits, record keeping etc.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Confidential Cipla Ltd Page 11 of 52 levonorgesterel (e.g., Norplant ® ), or injectable progesterone (e.g., Depo-Provera) or ? Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or ? Intrauterine device (IUD) or is of Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active 10. Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the investigator and being compliant with all study requirements (visits, record keeping etc.) Exclusion Criteria: 1. Upper respiratory tract infection or lower respiratory infection in the past 4 weeks that has not resolved within at least 2 weeks prior to the screening visit 2. History of known hypersensitivity or idiosyncratic reaction to Fluticasone propionate or Salmeterol, any component of the product or any related class of drugs (e.g., Salbutamol, Beclomethasone dipropionate) 3. Subjects with significant, uncontrolled comorbid conditions 4. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. 5. Any asthma exacerbation requiring oral corticosteroids within 3 months prior to the Screening Visit. A subject must not have had any hospitalization for asthma within 12 months prior to the Screening Visit. Note: An exacerbation of asthma is defined as any worsening of asthma requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization. 6.Have any of the following conditions that, in the judgment of the Version No 1.0: Final Eudra CT No. 2015-004455-52 Date: 14/10/2015 Confidential Cipla Ltd Page 12 of 52 investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to: ? Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit) ? Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years ? Uncontrolled hypertension (systolic BP =160 or diastolic BP >100) ? Stroke within 3 months prior to the Screening Visit ? Immunologic compromise ? History of a positive test for HIV, hepatitis B or hepatitis C. ? Clinical visual evidence of oral candidiasis at the Screening Visit. 7.Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, intraconzole) within 4 weeks prior to the Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will evaluate overall asthma control, as assessed by the Asthma Control Questionnaire (ACQ), in asthma subjects who are switched from Viani ® Evohaler 25/125 mcg to salmeterol/fluticasone propionate pMDI (Cipla Ltd) 25/125 mcg (taken as 2 actuations of 25/125 mcg/actuation) compared with overall asthma control in asthma subjects who are not switched from Viani ® Evohaler to salmeterol/fluticasone propionate pMDI. ;Secondary Objective: Not applicable;Primary end point(s): Primary Endpoint ? The difference in mean ACQ between Serroflo ® pMDI and Viani ® Evohaler after 4 weeks of treatment;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline to week 4 in pre dose FEV 1;Timepoint(s) of evaluation of this end point: from baseline to week 4 | — |
Countries
Germany
Contacts
Public ContactChief Medical Officer
Cipla Europe NV
Outcome results
None listed