CTRI/2021/03/032100招募中3 期
A Prospective, Multi-center, Randomized, Assessor-blind, Parallel-group, Comparative Clinical Endpoint Bioequivalence Study to Compare the Efficacy and Safety of Generic Fluticasone Propionate Inhalation Aerosol (pMDI, HFA 134a) (test drug) (of Macleods Pharmaceuticals Ltd) versus the Reference Listed Drug FLOVENT HFA (pMDI) Inhalation Aerosol and Efficacy and Safety of both Test and RLD to a Placebo-control in Treatment of Patients with Bronchial Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive)
- •2. Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 months prior to screening
- •3. Pre-bronchodilator FEV1 of more than or equal to 45% and less than or equal to 85% of the predicted normal value during the screening visit
- •4. Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening (Note:-Subject stabilized with dose of more than 250 mcg of Fluticasone should not be included in the study)
- •5. Currently non-smoking; has not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and has less than or equal to 10 pack years of historical use
- •6. More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) at screening (Note: Subjects not fulfilling reversibility of FEV1 at screening can be rescheduled for reversibility testing during the entire screening period and up to 1 day prior to randomization)
- •6 (a) More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) prior to randomization
- •7. Ability to discontinue their asthma medication (ICS and long-acting beta agonist) during the run-in period and for remainder of the study in the opinion of the investigator
- •8. Ability to replace short-acting beta agonists (SABAs) ongoing at screening with Salbutamol inhaler for use as needed for the duration of the study in the opinion of the Investigator; subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits
- •9. Women of childbearing potential must be willing to consistently use an appropriate method of contraception
- •10. Willingness to give their written informed consent to participate in the study
- •11. Is willing to comply with all aspects of the protocol
- •12. Ability to follow training given for study related procedures and assessments in the opinion of the Investigator
排除标准
- •1. Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening
- •2. Significant respiratory disease other than asthma 3. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus (HbA1c more than 10%) uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, cardiovascular, endocrine, or other diseases that, in the opinion of the investigator, would put the subject at risk through study period, or would affect the study analyses if the disease exacerbates during the study 4.Known hypersensitivity to any sympathomimetic drug (e.g., Salbutamol/Albuterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to propellant HFA-134a (1,1,1,2- tetrafluoroethane)
- •5. Subjects receiving B2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening 6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit 7. Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to screening
- •8. Evidence or history of oral candidiasis, tuberculosis, hypercorticism, adrenal suppression, or eye problems 9. Subjects scheduled for pre-planned surgery during the treatment period or in the opinion of the Investigator is expected to undergo surgery based on their medical history details at the time of screening
- •10. Female subjects who are pregnant or breast-feeding or planning to be pregnant & Participation in another clinical trial within 3 months before screening, History or current drug substance abuse
- •11.Subjects with history or current significant alcohol consumption which as per investigators judgment, make the subject ineligible to participate in the study 12.Any other medical, surgical,psychiatric conditions or laboratory abnormalities that would patient at risk through study participation,which as per investigators judgment,make the subject ineligible to participate in the study or may increase potential risk for subject associated with study participation or that may affect study results interpretation
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