Inhaled Steroid-Dependent AsthmaNCT07442617
Bridging the Gap Between Prescription and Practice: Impact of Nurse-Led Inhaler Education
A study testing Inhaler technique in people with Inhaled Steroid-Dependent Asthma, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inhaled Steroid-Dependent Asthma
- What is being tested?
- Inhaler technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Feb 2026
- 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 diagnosed with Asthma or COPD according to GINA / GOLD guidelines
- Current use of inhaler therapy (MDI, DPI, or Nebulizer) for ≥3 months.
- Able to understand instructions and perform inhaler technique assessments.
- Willing to provide informed consent and participate in all study assessments.
Who cannot join
- Acute exacerbation requiring hospitalization at the time of enrollment.
- Cognitive impairment or neurological disorders preventing understanding or proper inhaler use.
- Severe comorbidities (e.g., advanced heart failure, end-stage renal disease) that limit participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bridging the Gap Between Prescription and Practice: Impact of Nurse-Led Inhaler Education on Patient Technique, Knowledge, Adherence, and Beliefs - A Randomized Clinical Trial
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Although clinicians routinely advise patients verbally on inhaler use, the lack of structured, hands-on education results in significant variation in technique and consistently poor retention of skills over time.
Read the detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Inhaled therapy remains the cornerstone of management for both diseases, providing targeted delivery of bronchodilators and corticosteroids while minimizing systemic side effects.
Despite correct prescription of inhaler devices, a large proportion of patients demonstrate incorrect technique in inhaler use, leading to suboptimal drug delivery, poor symptom control, increased exacerbations, and frequent emergency department visits. Multiple factors contribute to this gap between prescription and real-world practice, including poor patient understanding of device mechanics, inappropriate inhalation patterns, and misconceptions about the nature and safety of inhaled corticosteroids.
Although clinicians routinely advise patients verbally on inhaler use, the lack of structured, hands-on education results in significant variation in technique and consistently poor retention of skills over time. Nurses, who often maintain the most direct and sustained contact with patients, represent an underutilized resource in addressing this gap. Previous studies indicate that nurse-led inhaler education can significantly enhance practical technique, reinforce adherence, and correct misconceptions about medication use. However, there is limited evidence on the long-term retention of inhaler skills and the impact of structured nurse training on both nurse competency and patient outcomes.
- Conditions
- Inhaled Steroid-Dependent Asthma
- Being tested
- Inhaler technique
- Keywords
- Inhaler technique, nurse-led inhaler education, Bronchial Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaler techniqueProcedure or surgery
Patient Education: Conducted by trained nurses using standardized checklist (GINA/GOLD)
| Study group | Role | What they receive |
|---|---|---|
| nurse-led inhaler education | Active comparator | Known Patients with asthma or COPD, using inhalers and education was Conducted by trained nurses using standardized checklist (Global Initiative for Asthma "GINA"/Global Initiative for Chronic Obstructive Lung Disease "GOLD") Receives: Procedure: Inhaler technique |
| Control group on inhaler | No intervention | Known Patients with asthma or COPD, using inhalers weren't trained |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of nurse-led education on inhaler technique
Participants will be evaluated to assess the impact of nurse-led education on technique Score: 152 This score evaluates the patient's ability to correctly use their inhaler. It covers nine key 153 components: ensuring the prescribed device type is used (MDI, DPI, or nebulizer), shaking 154 the MDI before use, complete exhalation before inhalation, proper lip seal around the 155 mouthpiece or spacer, correct inhalation speed according to device type, holding breath after 156 inhalation, rinsing the mouth after corticosteroid sprays, correct use of spacer devices, and 157 overall error correction. The maximum possible score is 9 points. Scores are interpreted as 158 follows: ≥8 indicates excellent technique, 5-7 represents moderate performance, and ≤4 159 indicates poor technique. The checklist was adapted from guideline-recommended inhaler 160 technique steps according to GINA and GOLD reports
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhaled Steroid-Dependent AsthmaStudies 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
- Model description
- Assess the effect of nurse-led inhaler education on patients' inhaler technique
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442617
- Sponsor's protocol ID
- R.26.02.3594
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap Between Prescription and Practice: Impact of Nurse-Led Inhaler Education on Patient Technique, Knowledge, Adherence, and Beliefs - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07442617
- Acronym / sponsor ID
- R.26.02.3594
- Conditions
- Inhaled Steroid-Dependent Asthma
- Keywords
- Inhaler technique, nurse-led inhaler education, Bronchial Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 2 Mar 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.
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Although clinicians routinely advise patients verbally on inhaler use, the lack of structured, hands-on education results in significant variation in technique and consistently poor retention of skills over time.
Detailed description
Asthma and chronic obstructive pulmonary disease (COPD) are among the most prevalent chronic respiratory conditions worldwide, affecting hundreds of millions of individuals and contributing substantially to morbidity, mortality, and healthcare burden. Inhaled therapy remains the cornerstone of management for both diseases, providing targeted delivery of bronchodilators and corticosteroids while minimizing systemic side effects.
Despite correct prescription of inhaler devices, a large proportion of patients demonstrate incorrect technique in inhaler use, leading to suboptimal drug delivery, poor symptom control, increased exacerbations, and frequent emergency department visits. Multiple factors contribute to this gap between prescription and real-world practice, including poor patient understanding of device mechanics, inappropriate inhalation patterns, and misconceptions about the nature and safety of inhaled corticosteroids.
Although clinicians routinely advise patients verbally on inhaler use, the lack of structured, hands-on education results in significant variation in technique and consistently poor retention of skills over time. Nurses, who often maintain the most direct and sustained contact with patients, represent an underutilized resource in addressing this gap. Previous studies indicate that nurse-led inhaler education can significantly enhance practical technique, reinforce adherence, and correct misconceptions about medication use. However, there is limited evidence on the long-term retention of inhaler skills and the impact of structured nurse training on both nurse competency and patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assess the effect of nurse-led inhaler education on patients' inhaler technique
| Arm | Type | Receives |
|---|---|---|
| nurse-led inhaler education | Active comparator | Procedure: Inhaler techniqueKnown Patients with asthma or COPD, using inhalers and education was Conducted by trained nurses using standardized checklist (Global Initiative for Asthma "GINA"/Global Initiative for Chronic Obstructive Lung Disease "GOLD") |
| Control group on inhaler | No intervention | –Known Patients with asthma or COPD, using inhalers weren't trained |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years diagnosed with Asthma or COPD according to GINA / GOLD guidelines
- Current use of inhaler therapy (MDI, DPI, or Nebulizer) for ≥3 months.
- Able to understand instructions and perform inhaler technique assessments.
- Willing to provide informed consent and participate in all study assessments.
Key exclusion criteria (3 listed)
- Acute exacerbation requiring hospitalization at the time of enrollment.
- Cognitive impairment or neurological disorders preventing understanding or proper inhaler use.
- Severe comorbidities (e.g., advanced heart failure, end-stage renal disease) that limit participation.
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 |
|---|---|---|
| Inhaler techniquePatient Education: Conducted by trained nurses using standardized checklist (GINA/GOLD) | Procedure or surgery | nurse-led inhaler education |
Primary outcome
impact of nurse-led education on inhaler technique
Time frame: 1 month
Participants will be evaluated to assess the impact of nurse-led education on technique Score: 152 This score evaluates the patient's ability to correctly use their inhaler. It covers nine key 153 components: ensuring the prescribed device type is used (MDI, DPI, or nebulizer), shaking 154 the MDI before use, complete exhalation before inhalation, proper lip seal around the 155 mouthpiece or spacer, correct inhalation speed according to device type, holding breath after 156 inhalation, rinsing the mouth after corticosteroid sprays, correct use of spacer devices, and 157 overall error correction. The maximum possible score is 9 points. Scores are interpreted as 158 follows: ≥8 indicates excellent technique, 5-7 represents moderate performance, and ≤4 159 indicates poor technique. The checklist was adapted from guideline-recommended inhaler 160 technique steps according to GINA and GOLD reports
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 2 Mar 2026.
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.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaler technique in people with Inhaled Steroid-Dependent Asthma, run by Mansoura University Hospital at 1 site in Egypt.
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 4 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 2 Mar 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 Egypt. 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?
impact of nurse-led education on inhaler technique (time frame: 1 month). 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 2 Mar 2026.