AsthmaticNCT05904002
Effect of Incentive Spirometery on Asthmatic Pregnant Women
A study testing pulmicort inhaler and Incentive spirometer treatment in people with Asthmatic and Pregnant With Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy. Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthmatic, Pregnant With Complication
- What is being tested?
- pulmicort inhaler and Incentive spirometer treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 15 Feb 2022
- 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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients will have the following criteria:
- Their age will range from 30 to40years old.
- Body mass index (BMI) will range from 25-29.9 kg/m2.
- All patients will be clinically and medically stable.
Who cannot join
- Patients will be excluded from the study if they have the following:
- Diabetes mellitus.
- Severe hypertension.
- Neurological and neuromuscular disorders.
- Blindness.
- Developed moderate and severe degree of pleural effusion.
- Cardiovascular instability.
- Chronic chest disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic faculty of physical therapy cairo university
Dokki
About this study
The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.
Read the detailed description
This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.
- Conditions
- Asthmatic, Pregnant With Complication
- Being tested
- pulmicort inhaler, Incentive spirometer treatment
- Medical subject headings
- Asthma, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmicort inhalerDrug
Each woman in both groups (A\&B) will receive pulmicort inhaler on needs.
Incentive spirometer treatmentDevice
Each patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course.
| Study group | Role | What they receive |
|---|---|---|
| pulmicort inhaler | Experimental | Group (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs. Receives: Drug: pulmicort inhaler |
| incentive spirometer | Experimental | Group (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks. Receives: Drug: pulmicort inhaler; Device: Incentive spirometer treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in lung functions
The spirometer will be used for assessment of lung functions including total lung capacity (TLC) (litre), which is the most widely used functional index in the asthma follow up.
Measured: at baseline and after 6 weeks of intervention
Assessing the change in symptoms of asthma
The Asthma Control Test provides a numerical score to help you and your healthcare provider determine if your asthma symptoms are well controlled. Take this test if you are 12 years or older. Share the score with your healthcare provider.
Measured: at baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Sep 2020
- Primary completion15 Sep 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaticStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Amin Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904002
- Sponsor's protocol ID
- Eman_Amin_2023
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Incentive Spirometery on Asthmatic Pregnant Women
- ClinicalTrials.gov ID
- NCT05904002
- Acronym / sponsor ID
- Eman_Amin_2023
- Conditions
- Asthmatic, Pregnant With Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 15 Jun 2023 (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.
The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.
Detailed description
This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmicort inhaler | Experimental | Drug: pulmicort inhalerGroup (A) consists of 30 patients. They will receive their inhaled glucocorticoids (pulmicort inhaler) on needs. |
| incentive spirometer | Experimental | Drug: pulmicort inhaler, Device: Incentive spirometer treatmentGroup (B) consists of 30 patients. They will receive the same medical treatment and incentive spirometer program 3 days per week for six weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Their age will range from 30 to40years old.
- Body mass index (BMI) will range from 25-29.9 kg/m2.
- All patients will be clinically and medically stable.
Key exclusion criteria (8 listed)
- Diabetes mellitus.
- Severe hypertension.
- Neurological and neuromuscular disorders.
- Blindness.
- Developed moderate and severe degree of pleural effusion.
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 |
|---|---|---|
| pulmicort inhalerEach woman in both groups (A\&B) will receive pulmicort inhaler on needs. | Drug | incentive spirometer, pulmicort inhaler |
| Incentive spirometer treatmentEach patient in group B will be instructed about the effects of incentive spirometer to gain their cooperation during the study course. | Device | incentive spirometer |
Primary outcome
Assessing the change in lung functions
Time frame: at baseline and after 6 weeks of intervention
The spirometer will be used for assessment of lung functions including total lung capacity (TLC) (litre), which is the most widely used functional index in the asthma follow up.
Assessing the change in symptoms of asthma
Time frame: at baseline and after 6 weeks of intervention
The Asthma Control Test provides a numerical score to help you and your healthcare provider determine if your asthma symptoms are well controlled. Take this test if you are 12 years or older. Share the score with your healthcare provider.
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 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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 pulmicort inhaler and Incentive spirometer treatment in people with Asthmatic and Pregnant With Complication, run by Cairo University 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 8 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 15 Jun 2023. 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?
Assessing the change in lung functions (time frame: at baseline and after 6 weeks of intervention). The study lists 2 primary outcomes in all. 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 15 Jun 2023.