Effectivenes of Pressurized Meter Dose Inhaler (PMDI) Versus Dry Powder Inhaler (DPI) in Delivering Inhaled Corticosteroid and Long Acting Beta Agonist Among Patients With Uncontrolled Asthma in a Tertiary Care Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Asthma Control Questionnaire (ACQ) score
研究概览
简要总结
This study compares two commonly used inhalation devices in asthma management. It focuses on evaluating how effectively PMDIs and DPIs deliver the same combination of inhaled corticosteroids and long-acting beta agonists in patients whose asthma remains poorly controlled despite treatment. The study is conducted in a tertiary care hospital setting, emphasizing real-world clinical practice and aiming to determine whether device choice influences asthma control outcomes.
详细描述
Asthma is a common chronic respiratory disease, and despite advances in therapy, a significant proportion of patients remain poorly controlled. Inhaled corticosteroids (ICS) combined with long-acting beta agonists (LABA) are the cornerstone of asthma management; however, the effectiveness of treatment is highly dependent on the inhalation device used. Pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) are the most widely used devices, yet their relative effectiveness in real-world clinical practice remains debated, particularly in resource-limited settings.
This randomized controlled trial aims to compare the effectiveness of pMDI versus DPI in delivering equivalent doses of ICS/LABA among patients with uncontrolled asthma attending the Pulmonology Outpatient Department of Services Hospital Lahore. A total of 210 patients aged 14-60 years with uncontrolled asthma, defined by an Asthma Control Questionnaire (ACQ) score ≥3 despite baseline therapy, will be enrolled using non-probability consecutive sampling and randomized into two groups. Both groups will receive an equivalent total daily dose of budesonide/formoterol (800/24 µg), administered either via pMDI or DPI.
Patients will be followed for eight weeks with assessments at baseline, four weeks, and eight weeks. The primary outcome will be improvement in asthma control measured by reduction in ACQ score, while secondary outcomes include frequency of asthma exacerbations. Data will be analyzed using SPSS version 25, with appropriate statistical tests applied to compare outcomes between groups.
The findings of this study are expected to clarify whether inhaler device choice significantly influences asthma control. This will help distinguish true treatment-resistant asthma from poor control due to device-related factors and guide clinicians in selecting the most effective inhalation device for improved patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14 to 60 years
- •Both genders
- •All patients with symptoms of uncontrolled asthma
排除标准
- •Patients with coexistent fungal sensitization (confirmed with peripheral eosinophil count and serum IgE)
- •Patients with coexistent Allergic Bronchopulmonary Aspergillosis (ABPA) (confirmed with HRCT and serum IgE)
- •Patients with coexistent COPD (confirmed on spirometry)
- •Patients with Hypersensitivity Pneumonitis
- •Patients with coexistent Interstitial Lung Disease (ILD) (confirmed on spirometry)
- •Patients with coexistent cardiac asthma secondary to heart failure (diagnosed on echocardiography)
研究组 & 干预措施
Group A
Patients in this arm will receive a fixed-dose combination of inhaled corticosteroid and long-acting beta agonist (budesonide/formoterol) via a pressurized metered dose inhaler. The prescribed dose will be 200/6 µg per puff, two puffs twice daily, delivering a total daily dose of 800/24 µg. This arm evaluates the effectiveness of aerosol-based drug delivery requiring hand-breath coordination.
干预措施: Pressurized Metered Dose Inhaler (pMDI) (Device)
Group B
Patients in this arm will receive the same fixed-dose combination of budesonide/formoterol via a dry powder inhaler at a dose of 400/12 µg per puff, one puff twice daily, achieving the same total daily dose of 800/24 µg. This arm assesses the effectiveness of breath-actuated powder-based drug delivery.
Both arms use equivalent drug molecules and doses, with the inhaler device being the only variable, allowing direct comparison of device-related effectiveness in uncontrolled asthma.
If you want, I can also write this in tabular form or CPSP RTMC-preferred wording.
干预措施: Dry Powder Inhaler (Device)
结局指标
主要结局
Asthma Control Questionnaire (ACQ) score
时间窗: 8 weeks
The primary outcome of this study is improvement in asthma control, assessed by the change in Asthma Control Questionnaire (ACQ) score from baseline to 8 weeks after intervention. Effectiveness will be determined by a reduction in ACQ score compared to the baseline value, reflecting better symptom control with the assigned inhaler device.
次要结局
未报告次要终点
研究者
Laiba Qamar
Principal Investigator
University of Health Sciences Lahore