EUCTR2015-004455-52-DE进行中（未招募）1 期
An open label, prospective, randomized, parallel group, multicenter 4-week study to evaluate the efficacy and safety of salmeterol/ fluticasone propionate fixed dose combination following a switch from Viani ® Evohaler to Serroflo ® pressurized metered dose inhaler (pMDI) in subjects with stable persistent asthma
Cipla Europe NV0 个研究点开始时间: 2015年12月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Confidential Cipla Ltd Page 10 of 52
- •ELIGIBILITY
- •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
- •? 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
- 另有 7 项未显示
排除标准
- •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
- •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
- 另有 8 项未显示
研究者
相似试验
进行中（未招募）
1 期
A prospective, open label, randomised, parallel group, comparative pilot study to study the efficacy and safety of highly purified Menotrophin versus recombinant FSH (Follitropin alfa) administered subcutaneously to subfertile female patients undergoing IVF using antagonist downregulation. - PROSPECTsub fertilityMedDRA version: 7.1 Level: LLT Classification code 10042391EUCTR2004-001307-35-GBFerring Arzneimittel GmbH72
已完成
1 期
TESTING OF HAND SANITIZER.CTRI/2021/08/035597Guru Nanak Dev University Amritsar300
已完成
4 期
Post marketing study to validate the efficacy and safety of SAILIN HBS in patients with sickle cell disease.CTRI/2023/07/055773Sai Phytoceuticals (P) Ltd50
尚未招募
不适用
A study to compare efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with moderate to severe Acne VulgarisCTRI/2018/05/013916Dr Apoorva
已完成
不适用
Effect of lens wear on bacterial adhesion to lens surfacesACTRN12608000557336Institute for Eye Research60