Asthma (Diagnosis)NCT07372573
Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler
A study testing Pressurized Metered Dose Inhaler (pMDI) and Dry Powder Inhaler in people with Asthma (Diagnosis), run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- Pressurized Metered Dose Inhaler (pMDI) and Dry Powder Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14 to 60 years
- Both genders
- All patients with symptoms of uncontrolled asthma
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Services Hospital Lahore
Lahore, Punjab Province, 54000
Muhammad Hussain Dr, MBBS, FCPS, +92321 4783306, laibaqamar640@gmail.com
About this study
Official title: 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.
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.
Read the detailed description
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.
- Conditions
- Asthma (Diagnosis)
- Being tested
- Pressurized Metered Dose Inhaler (pMDI), Dry Powder Inhaler
- Keywords
- Asthma, Pressrized Meter Dose inhaler, Dry powder Inhaler, long acting beta Agonist, inhaled corticosteroid
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 InhalerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Device: Pressurized Metered Dose Inhaler (pMDI) |
| Group B | Active comparator | 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. Receives: Device: Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiba Qamar, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372573
- Sponsor's protocol ID
- #PMDIDPI#
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07372573
- Acronym / sponsor ID
- #PMDIDPI#
- Conditions
- Asthma (Diagnosis)
- Keywords
- Asthma, Pressrized Meter Dose inhaler, Dry powder Inhaler, long acting beta Agonist, inhaled corticosteroid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Pressurized Metered Dose Inhaler (pMDI)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. |
| Group B | Active comparator | Device: Dry Powder InhalerPatients 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 14 to 60 years
- Both genders
- All patients with symptoms of uncontrolled asthma
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/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. | Device | Group A |
| Dry Powder Inhalerarticipants 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. | Device | Group B |
Primary outcome
Asthma Control Questionnaire (ACQ) score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressurized Metered Dose Inhaler (pMDI) and Dry Powder Inhaler in people with Asthma (Diagnosis), run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syeda Xunaira Qamar Dr, MBBS (+92 302 8685212, Syedaxunairaqamar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (ACQ) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.