[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621588":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":34,"overallOfficials":13,"centralContacts":44,"locations":50,"responsibleParty":69,"collaborators":13,"id":73,"slug":13,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":13,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":13,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":97,"whyStopped":13,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Asthma Control Questionnaire (ACQ) score","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.","8 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","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.\n\nThis randomized controlled trial aims to compare the effectiveness of pMDI versus DPI in delivering equivalent doses of ICS\u002FLABA 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\u002Fformoterol (800\u002F24 µg), administered either via pMDI or DPI.\n\nPatients 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.\n\nThe 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.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"Group A","EXPERIMENTAL","Patients in this arm will receive a fixed-dose combination of inhaled corticosteroid and long-acting beta agonist (budesonide\u002Fformoterol) via a pressurized metered dose inhaler. The prescribed dose will be 200\u002F6 µg per puff, two puffs twice daily, delivering a total daily dose of 800\u002F24 µg. This arm evaluates the effectiveness of aerosol-based drug delivery requiring hand-breath coordination.",[27],"Device: Pressurized Metered Dose Inhaler (pMDI)",{"label":29,"type":30,"description":31,"interventionNames":32},"Group B","ACTIVE_COMPARATOR","Patients in this arm will receive the same fixed-dose combination of budesonide\u002Fformoterol via a dry powder inhaler at a dose of 400\u002F12 µg per puff, one puff twice daily, achieving the same total daily dose of 800\u002F24 µg. This arm assesses the effectiveness of breath-actuated powder-based drug delivery.\n\nBoth 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.\n\nIf you want, I can also write this in tabular form or CPSP RTMC-preferred wording.",[33],"Device: Dry Powder Inhaler",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","Pressurized Metered Dose Inhaler (pMDI)","Participants allocated to this group will be treated with a combination of inhaled corticosteroid and long-acting beta agonist in the form of budesonide\u002Fformoterol 200\u002F6 micrograms per actuation delivered via a pressurized metered dose inhaler. Patients will be instructed to take two puffs twice daily, resulting in a total daily dose of 800 micrograms of budesonide and 24 micrograms of formoterol. This intervention evaluates medication delivery through an aerosolized spray that requires proper coordination between actuation and inhalation.",[23],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"Dry Powder Inhaler","articipants in this group will receive the same combination therapy of budesonide\u002Fformoterol 400\u002F12 micrograms per inhalation administered through a dry powder inhaler. The prescribed regimen will be one inhalation twice daily, providing an equivalent total daily dose of 800 micrograms of budesonide and 24 micrograms of formoterol. This intervention assesses drug delivery via a breath-activated powder formulation, where adequate inspiratory effort is required for optimal drug deposition.",[29],[45],{"name":46,"role":47,"phone":48,"phoneExt":13,"email":49},"Syeda Xunaira Qamar Dr, MBBS","CONTACT","+92 302 8685212","Syedaxunairaqamar@gmail.com",[51],{"facility":52,"status":13,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Services Hospital Lahore","Lahore","Punjab Province","54000","Pakistan","PK",{"type":59,"coordinates":60},"Point",[61,62],74.35071,31.558,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":67,"phoneExt":13,"email":68},"Muhammad Hussain Dr, MBBS, FCPS","+92321 4783306","laibaqamar640@gmail.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Laiba Qamar","Principal Investigator","100621588",false,"NCT07372573","Pressurized Meter Dose Inhaler V\u002FS Dry Powder Inhaler","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.","Inclusion Criteria:\n\nAge 14 to 60 years\n\nBoth genders\n\nAll patients with symptoms of uncontrolled asthma\n\nExclusion Criteria:\n\nPatients with coexistent fungal sensitization (confirmed with peripheral eosinophil count and serum IgE)\n\nPatients with coexistent Allergic Bronchopulmonary Aspergillosis (ABPA) (confirmed with HRCT and serum IgE)\n\nPatients with coexistent COPD (confirmed on spirometry)\n\nPatients with Hypersensitivity Pneumonitis\n\nPatients with coexistent Interstitial Lung Disease (ILD) (confirmed on spirometry)\n\nPatients with coexistent cardiac asthma secondary to heart failure (diagnosed on echocardiography)","ALL","14 Years","60 Years",{"count":83,"type":84},210,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.",[90],"Asthma (Diagnosis)",[92,93,94,95,96],"Asthma","Pressrized Meter Dose inhaler","Dry powder Inhaler","long acting beta Agonist","inhaled corticosteroid","NOT_YET_RECRUITING","2026-01-19",{"date":100,"type":101},"2026-01-28","ACTUAL",{"date":103,"type":84},"2026-02-01",{"date":105,"type":84},"2026-07-31",{"name":5,"class":6},1]