A Prospective, Single-center, Single-Arm, Open-Label, Study To Assess The Effectiveness And Safety Of Triamcinolone Oral Tablet In Management of Acute Exacerbations Of Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To evaluate the effectiveness of triamcinolone oral tablets adjunct to standard of care (SOC) treatment in managing mild to moderate acute exacerbations of asthma symptoms, assessed by asthma control questionnaire-6 (ACQ-6) in routine outpatient clinical settings.
研究概览
简要总结
This is a prospective, single-center, single-arm, open-label, study designed to assess the effectiveness and safety of triamcinolone oral tablets adjunct to SOC treatment in the management of patients with mild to moderate acute exacerbations of asthma. This study plans to enroll 100 patients with mild to moderate acute exacerbation of asthma. The patients will be followed up for 7-days after enrollment into the study. The patients will be prescribed triamcinolone tablets at a dose of 4mg to 16mg per day,as per the discretion of the investigator, for a period of Seven (7)-days, to be taken with water preferably after meals, adjunct to SOC treatment, which will include inhaled corticosteroids (ICS) with or without long-acting beta2-agonist (LABA).
The selection of patients for the study will be totally at the discretion of the investigator. All patients diagnosed withmild to moderate acute exacerbation of asthma, meeting inclusion & exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this study.
At the baseline (Visit 1 [Day 0]), informed consent will be taken, before assessing the patient’s eligibility and entry into the study. Patients fulfilling all of the inclusion and violating none of the exclusion criteria will be enrolled in the study. Post entry of a patient into the study demographic details- age, gender, and socioeconomic status, will also be captured and clinical examination, which will include a record of vitals (including BP, HR, and RR), physical and systemic examination, will be done. Detailed medical history (including duration of disease, present treatment regime, co-existing condition, etc.) will be taken.
At baseline (Visit 1 [Day 0]), patients with acute exacerbations of asthma will be evaluated for adequacy of asthma control by ACQ-6 and assessment of lung functions by FEV1 and PEFR. The patient will also be prescribed oral triamcinolone 4mg tablets at a dose of 4mg to 16 mg per day, as per the discretion of the investigator, for the period of Seven (7)-days at the baseline, along with SOC treatment (ICS with or without LABA). Progress made by the patient will be reviewed on Day Seven (7) (end of study visit).
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.Patients of either sex in the age group of ≥18-≤65 years.
- •2.Previously diagnosed case of bronchial asthma for at least 6 months, before the screening date.
- •3.A primary diagnosis of mild to moderate acute exacerbation of asthma (with symptoms of shortness of breath, frequent or recurrent cough, wheezing, mucus production, and/ or tightness in the chest) on presentation.
- •4.Patients on a stable dose of asthma medications for at least 3 months, before the screening date.
- •5.No other acute pathology complicating the present condition i.e. cardiac, metabolic, or any other respiratory causes.
- •6.Patients willing to participate in the study and sign an informed consent form.
排除标准
- •A patient will be excluded from the study if they meet any of the following criteria: 1.Patients with a smoking history of more than 10 packs a year.
- •2.Patients with a history of Alcohol consumption.
- •3.Patients treated with oral or parenteral steroids for >5 days in the past 30-days.
- •4.Patients treated with theophylline ≤5-days, before the screening date.
- •5.Patients having uncontrolled diabetes or uncontrolled hypertension.
- •6.Patients having active tuberculosis.
- •7.Patients on regular Rifampicin, Phenytoin, or Phenobarbitone.
- •8.Pregnant and nursing women.
- •9.Women with childbearing potential who are not practicing a reliable method of birth control.
- •11.Suspected inability or unwillingness to comply with study procedures.
结局指标
主要结局
1.To evaluate the effectiveness of triamcinolone oral tablets adjunct to standard of care (SOC) treatment in managing mild to moderate acute exacerbations of asthma symptoms, assessed by asthma control questionnaire-6 (ACQ-6) in routine outpatient clinical settings.
时间窗: Day 0 and 7
次要结局
- 1.To evaluate the effectiveness of triamcinolone oral tablets adjunct to SOC treatment in improving lung function in patients with mild to moderate acute exacerbations of asthma, in routine outpatient clinical settings(Day 0 and 7)