Asthma (Diagnosis)NCT07232264
Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Comparison of DPI and MDI Devices
A study testing MDI Inhaler Therapy and DPI Inhaler Therapy in people with Asthma (Diagnosis), run by Bugra Kerget at 1 site in Turkey (Türkiye).
Trial summary
Asthma is a chronic respiratory disease characterized by variable airway obstruction. Inhaled therapies are the cornerstone of asthma management, and selecting the appropriate inhaler device is essential for effective treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma (Diagnosis)
- What is being tested?
- MDI Inhaler Therapy and DPI Inhaler Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years Newly diagnosed asthma according to GINA guidelines Education level of at least high school Ability to use inhaler devices correctly after standardized training Provided written informed consent to participate
Who cannot join
- Presence of other chronic lung diseases (e.g., COPD, interstitial lung disease) Acute asthma exacerbation at the time of enrollment Severe neurological or cognitive impairment affecting inhaler use
- Pregnancy or breastfeeding
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Randomized Comparison of Dry Powder and Metered Dose Inhalers
Asthma is a chronic respiratory disease characterized by variable airway obstruction. Inhaled therapies are the cornerstone of asthma management, and selecting the appropriate inhaler device is essential for effective treatment. Among available devices, metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are commonly used; however, their effectiveness depends not only on the medication but also on the patient's physiological capacity and inhalation technique.
This prospective randomized study aimed to evaluate the factors influencing inhaler treatment response in newly diagnosed asthma patients. A total of 80 patients with at least a high school education, who demonstrated perfect inhaler technique and adherence, were randomly assigned to MDI or DPI groups (n = 40 each). Baseline and one-month follow-up assessments included pulmonary function tests (PFTs), inspiratory and expiratory muscle strength measurements (MIP, MEP), Asthma Control Test (ACT), and handgrip strength (HGS).
The study investigated how respiratory and peripheral muscle strength, inspiratory capacity, coordination skills, and clinical status affect treatment outcomes with MDI and DPI. Findings from this research may help guide inhaler selection based on patient-specific physiological characteristics to optimize treatment effectiveness.
- Conditions
- Asthma (Diagnosis)
- Being tested
- MDI Inhaler Therapy, DPI Inhaler Therapy
- Medical subject headings
- Asthma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDI Inhaler TherapyDrug
Patients in the MDI group received Foster® metered-dose inhaler (MDI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, administered as two puffs twice daily for one month.
DPI Inhaler TherapyDrug
Patients in the DPI group received Foster® Nexthaler dry powder inhaler (DPI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, administered as two inhalations twice daily for one month.
| Study group | Role | What they receive |
|---|---|---|
| MDI Group | Experimental | Participants receive inhaled therapy using metered-dose inhalers (MDIs) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, 2 puffs twice daily for one month. Receives: Drug: MDI Inhaler Therapy |
| DPI Group | Experimental | Participants receive inhaled therapy using dry powder inhalers (DPIs) (Foster® Nexthaler) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, 2 inhalations twice daily for one month. Receives: Drug: DPI Inhaler Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV₁ (%) from Baseline to 1 Month
The primary outcome is the change in forced expiratory volume in one second (FEV₁) expressed as percent of predicted from baseline to one month after initiation of inhaler therapy. Pulmonary function tests were performed according to ATS/ERS 2019 guidelines using the same spirometry device for all participants.
Measured: Baseline and 1 month after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Mar 2025
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
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.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bugra Kerget
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bugra Kerget, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232264
- Sponsor's protocol ID
- B.30.2ATA.0.01.00/600
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Randomized Comparison of Dry Powder and Metered Dose Inhalers
- ClinicalTrials.gov ID
- NCT07232264
- Acronym / sponsor ID
- B.30.2ATA.0.01.00/600
- Conditions
- Asthma (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bugra KergetUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 18 Nov 2025 (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.
Asthma is a chronic respiratory disease characterized by variable airway obstruction. Inhaled therapies are the cornerstone of asthma management, and selecting the appropriate inhaler device is essential for effective treatment. Among available devices, metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are commonly used; however, their effectiveness depends not only on the medication but also on the patient's physiological capacity and inhalation technique.
This prospective randomized study aimed to evaluate the factors influencing inhaler treatment response in newly diagnosed asthma patients. A total of 80 patients with at least a high school education, who demonstrated perfect inhaler technique and adherence, were randomly assigned to MDI or DPI groups (n = 40 each). Baseline and one-month follow-up assessments included pulmonary function tests (PFTs), inspiratory and expiratory muscle strength measurements (MIP, MEP), Asthma Control Test (ACT), and handgrip strength (HGS).
The study investigated how respiratory and peripheral muscle strength, inspiratory capacity, coordination skills, and clinical status affect treatment outcomes with MDI and DPI. Findings from this research may help guide inhaler selection based on patient-specific physiological characteristics to optimize treatment effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDI Group | Experimental | Drug: MDI Inhaler TherapyParticipants receive inhaled therapy using metered-dose inhalers (MDIs) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, 2 puffs twice daily for one month. |
| DPI Group | Experimental | Drug: DPI Inhaler TherapyParticipants receive inhaled therapy using dry powder inhalers (DPIs) (Foster® Nexthaler) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, 2 inhalations twice daily for one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥ 18 years Newly diagnosed asthma according to GINA guidelines Education level of at least high school Ability to use inhaler devices correctly after standardized training Provided written informed consent to participate
Key exclusion criteria (3 listed)
- Presence of other chronic lung diseases (e.g., COPD, interstitial lung disease) Acute asthma exacerbation at the time of enrollment Severe neurological or cognitive impairment affecting inhaler use
- Pregnancy or breastfeeding
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| MDI Inhaler TherapyPatients in the MDI group received Foster® metered-dose inhaler (MDI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, administered as two puffs twice daily for one month. | Drug | MDI Group |
| DPI Inhaler TherapyPatients in the DPI group received Foster® Nexthaler dry powder inhaler (DPI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, administered as two inhalations twice daily for one month. | Drug | DPI Group |
Primary outcome
Change in FEV₁ (%) from Baseline to 1 Month
Time frame: Baseline and 1 month after treatment initiation
The primary outcome is the change in forced expiratory volume in one second (FEV₁) expressed as percent of predicted from baseline to one month after initiation of inhaler therapy. Pulmonary function tests were performed according to ATS/ERS 2019 guidelines using the same spirometry device for all participants.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDI Inhaler Therapy and DPI Inhaler Therapy in people with Asthma (Diagnosis), run by Bugra Kerget at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV₁ (%) from Baseline to 1 Month (time frame: Baseline and 1 month after treatment initiation). 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 18 Nov 2025.