Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler

ConditionAsthma (Diagnosis)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14-60

SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Pressurized Metered Dose Inhaler (pMDI)
Device
Participants allocated to this group will be treated with a combination of inhaled corticosteroid and long-acting beta agonist in the form of budesonide/formoterol 200/6 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.
Dry Powder Inhaler
Device
articipants in this group will receive the same combination therapy of budesonide/formoterol 400/12 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.

Treatment groups

210 Participants

are divided into 2 treatment groups

Group A: Group AExperimental treatment 1 intervention

Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Health Sciences Lahore

Lead sponsor

Source ClinicalTrials.gov

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