An open label, multi-centric, prospective clinical trial to evaluate safety and efficacy of fixed dose combination of Montelukast 10 mg plus Acebrophylline SR 200 mg tablet in patients having bronchial asthma in India
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 14
- 主要终点
- 1.Primary Outcome measure: (Safety)
研究概览
简要总结
This is a phase IV, multi-centric, open-label, prospective study toevaluate safety and efficacy of fixed dose combination of Montelukast 10 mgplus Acebrophylline SR 200 mg tablet in patients having bronchial asthma. Approximately206 Male or female patients with age 18 - 65 years having confirmed diagnosisof asthma as per GINA 2018 guideline since at least 3 months prior to screeningand who are having current sign/ symptoms of asthma or need for SABA more thantwice a week will be enrolled in this study. Study consists of 05 visits (oneScreening Visit, one Baseline Visit, two Follow up Visits and one End ofTreatment Visit). Study duration will be of 14 weeks, including 02 weeks ofscreening period (maximum) and treatment duration of all enrolled patients willbe of 12 weeks.
PrimaryOutcome measure: (Safety)
· Proportionof participants with adverse events and serious adverse events [Time frame: 84days]Secondary outcomemeasure(s): (Efficacy)
· Change in Trough ForcedExpiratory Volume in 1 second (FEV1) from baseline to the end of treatment.[Time frame: 28, 56, 84 days]
· Change in ASUI scorefrom baseline [Time frame: 28, 56, 84 days]
· Change in Forced VitalCapacity from baseline. [Time frame: 28, 56, 84 days]
Number of rescue medication (Short acting beta-2agonists) used during study period. It shall be captured by Mean of occasions(not puffs) of SABA use per day, averaged over 1 week [Time frame: 28, 56, 84days]
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patient with age
- •65 years (both inclusive) 2.Patient having confirmed diagnosis of asthma as per GINA 2018 guideline since at least 3 months prior to screening 3.Patient having current sign/symptoms of asthma or need for SABA more than twice a week 4.Patient who is suitable to take Montelukast and Acebrophylline as per GINA 2018 guideline 5.Female patient of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test. Effective contraceptive include (e.g. barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method†6.Except asthma disorder patient is judged to be in general good health to participate in trial based on medical history and physical examination as assessed by the Investigator 7.Written informed consent signed by patient and willing to comply with the study procedure.
排除标准
- •1.Pregnant or lactating female patient 2.Hospitalization due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit) 3.Patient with clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigators 4.Patient has a history of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to enrollment 5.Patient who had received leukotriene antagonist and/ or Acebrophylline within 3 days of enrolment 6.Patient with concurrent, previous or possible alcohol dependence, drug dependence or narcotic addiction as per DSM-5 7.Patient who have earlier participated in any other clinical trial within three months of screening 8.Patient with a known history of clinically significant (including but not limited to) acute myocardial infarction, impaired hemodynamics, psychiatric, hepatic or/and renal disorders, Ambroxol allergy, GI disorders, phenylketonuria, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax convulsion, arrhythmia, CAD, cardiac insufficiency and hyperthyroidism 9.Patient with known history of Hypersensitivity to Acebrophylline or Montelukast or any other leukotriene antagonists or asprin or theophylline or any other xanthine derivative 10.History of hepatitis B, hepatitis C or HIV infection 11.Patient with type 2 diabetes (HbA1c > 9 % at screening) 12.Patient with current history of uncontrolled hypertension (SeSBP ≥ 140 and/ or SeDBP ≥ 90 mm of Hg) 13.Current smoker or past smoker with a smoking history of ≥ 10 pack years 14.Patient with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug 15.Patient judged unfit for this study by investigator 16.Investigator, study personnel, sponsor representatives and their first degree relatives.
结局指标
主要结局
1.Primary Outcome measure: (Safety)
时间窗: Time frame: 84 days
Proportion of participants with adverse events and serious adverse events
时间窗: Time frame: 84 days
次要结局
- Change in Trough Forced Expiratory Volume in 1 second (FEV1) from baseline to the end of treatment(Time frame: 28, 56, 84 days)
- Change in ASUI score from baseline(Time frame: 28, 56, 84 days)
- Change in Forced Vital Capacity from baseline(Time frame: 28, 56, 84 days)
- Number of rescue medication (Short acting beta-2 agonists) used during study period. It shall be captured by Mean of occasions (not puffs) of SABA use per day, averaged over 1 week(Time frame: 28, 56, 84 days)