CTRI/2022/08/044640已完成3 期
A Multicenter, Randomized, Parallel-Group, 6-Week Treatment Clinical Study to Assess Bioequivalence of Budesonide 80 µg and Formoterol Fumarate Dihydrate 4.5 µg Inhalation Product (Cipla Ltd.) in comparison with the Reference Product, Symbicort® (Budesonide/Formoterol Fumarate Dihydrate, 80/4.5 µg per Actuation) Inhalation Aerosol (AstraZeneca, USA), in Adult Asthma Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 1,191
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Is capable of understanding consent form and provides written informed consent and agrees to comply with protocol requirements.
- •2.Male or female patients who are 18-70 years of age (both inclusive) at the time informed consent is obtained.
- •3.Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program [NAEPP 2007] at least 6 months prior to screening.
- •4.Has moderate to severe asthma with a pre bronchodilator FEV1 of =45% and <80% of the predicted normal value for the patient after withholding bronchodilators (see Appendix 17.2) at both run-in initiation visit (Visit 2) and randomization visit (Visit 4).
- •Withholding period of bronchodilators prior to spirometry:
- •oSABA for =6 hours
- •oLABA for =48 hours
- •oUltra-LABA =96 hours
- •5.Has =15% and =0.20 L reversibility of FEV1 within 30 minutes following administration of 360 µg of albuterol (pMDI).
- •All patients must perform a reversibility test at run in visit (Visit 2).
- •If all screening eligibility criteria are met except FEV1 reversibility at run-in visit (Visit 2), reversibility may be repeated once, on a different day, within 7 days. If FEV1 reversibility is not met on the repeat assessment, further rescreening will not be allowed (Section 3.2.2).
- •6.Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1).
- •7.Is able to discontinue current asthma medications, as well as prohibited medications listed in Appendix 17.2, during the run in period and for remainder of the study.
- •8.Is able to replace their current SABA inhaler with the study provided albuterol (pMDI) inhaler to be used as rescue medicine (as needed) throughout the study and is able to withhold SABAs for at least 6 hours prior to lung function assessments on study visits.
- •9.Adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control (Appendix 17.4).
排除标准
- •1.Has history of life threatening asthma defined as asthma episode(s) that required intubation and/or was associated with hypercapnoea, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run in period.
- •2.Has history of any asthma related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period.
- •3.Has had any asthma exacerbation requiring emergency room visits or systemic corticosteroids within 2 months prior to screening visit (Visit 1) or during the run-in period.
- •4.Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma.
- •5.Has history of confirmed COVID-19 positivity in the past 3 months or any COVID-19 related hospitalization requiring oxygen therapy in the past.
- •6.Has evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension (systolic blood pressure [BP] =160 mmHg or diastolic BP >100 mmHg), uncontrolled coronary artery disease, myocardial infarction, stroke within 3 months prior to the screening visit (Visit 1), or cardiac dysrhythmia.
- •7.Has historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- •8.Has current clinical evidence of bronchopulmonary dysplasia or pulmonary fibrosis.
- •9.Has obstructive sleep apnea warranting a prescription for continuous or biphasic positive airway pressure, regardless of patient compliance with this prescription.
- •10.Has history of any adverse reaction; known hypersensitivity to any sympathomimetic drug (e.g. formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy or any other constituents of the study treatment medication
- •11.Use of medication(s) with potential to affect the course of asthma or to interact with sympathomimetic amines throughout the study period, including but not limited to ß blockers, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, ephedrine, isoproterenol (Appendix 17.2).
- •12.Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator.
- •13.Is a current smoker or ex-smoker •If cotinine test is positive at screening (Visit 1), no retesting will be allowed.
- •14.Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs will be excluded.
- •15.Patients who have inhaled tobacco, consumed other tobacco containing products (e.g. cigars, pipe tobacco), or smoked marijuana within 12 months of screening visit (Visit 1) will be excluded.
- •16.Use of systemic corticosteroids (for any reason other than asthma) within the past 2 months or during the run-in period. Use of intramuscular depot corticosteroids within the past 90 days or during the run-in period. Intranasal corticosteroids, topical corticosteroids for dermatological diseases and ophthalmic and intra articul
研究者
相似试验
未知
4 期
A 16-week Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on InsuliType 2 Diabetes MellitusJPRN-jRCT1080222537AstraZeneca
进行中（未招募）
1 期
Study to assess the effect of AZD3241 in Multiple System AtrophyMultiple system atrophy (MSA)MedDRA version: 18.1Level: PTClassification code 10064060Term: Multiple system atrophySystem Organ Class: 10029205 - Nervous system disordersEUCTR2014-004902-13-SEAstraZeneca AB64
进行中（未招募）
1 期
Study to assess the effect of AZD3241 in Multiple System AtrophyEUCTR2014-004902-13-FIAstraZeneca AB64
进行中（未招募）
1 期
Study to assess the effect of AZD3241 in Multiple System AtrophyMultiple system atrophy (MSA)MedDRA version: 18.1 Level: PT Classification code 10064060 Term: Multiple system atrophy System Organ Class: 10029205 - Nervous system disordersEUCTR2014-004902-13-GBAstraZeneca AB59
进行中（未招募）
不适用
A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosisTreatment statisfaction in patients with relapsing remitting Multiple SclerosisMedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-002637-11-DEovartis Pharma GmbH