Allergic AsthmaPHASTERNCT05749237
The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma
A study testing respiratory exercises and relaxation exercises in people with Allergic Asthma, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- respiratory exercises and relaxation exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2023to 30 Aug 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 -
Who cannot join
- asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul
Ayca Kiykim, +905423432245, ayca.kiykim@iuc.edu.tr
Betul Gemici Karaaslan
About this study
The goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma.
Participants will be asked to perform respiratory exercises described at once in hospital at home regularly. Control group will comprised children with asthma without respiratory exercises.
Read the detailed description
At the beginning of the study anthropometric measurements, basal respiratory function assessment, drugs, demographic information, allergen sensitivity, asthma control levels and quality of life scales will be documented. Patients will be randomly divided into two groups; one group following respiratory exercises and relaxation exercises and the other following only relaxation exercises. Both groups will be called regularly to remind the exercises.
The spirometric tests and asthma control forms will be reevaluated at the 3rd and 6th month at hospital.
Peak flow meters will be given to patients to document PEF values during study.
- Conditions
- Allergic Asthma
- Being tested
- respiratory exercises, relaxation exercises
- Keywords
- allergy, asthma, respiratory exercises, children
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory exercisesOther
respiratory exercises
relaxation exercisesOther
relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | children older than 10 years with a diagnosis of allergic asthma respiratory and relaxation exercises Receives: Other: respiratory exercises; Other: relaxation exercises |
| Placebo group | Placebo comparator | children older than 10 years with a diagnosis of allergic asthma only relaxation exercises Receives: Other: relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma attack frequency
asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts
Measured: at third and sixth months
Secondary outcomes (1)
Quality of life questionnaire
increase quality of life
Measured: at third and sixth months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start3 Feb 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Model description
- Randomized placebo controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Kiykim, Istanbul University - Cerrahpasa
- Investigators
- Ayca Kiykim, Principal investigator, Istanbul University - CerrahpasaHilal Denizoglu, Study chair, Atlas UniversityHikmet Uçgun, Study chair, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749237
- Sponsor's protocol ID
- Phaster
- Acronym
- PHASTER
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma
- ClinicalTrials.gov ID
- NCT05749237
- Acronym / sponsor ID
- PHASTER / Phaster
- Conditions
- Allergic Asthma
- Keywords
- allergy, asthma, respiratory exercises, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 1 Mar 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 goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma.
Participants will be asked to perform respiratory exercises described at once in hospital at home regularly. Control group will comprised children with asthma without respiratory exercises.
Detailed description
At the beginning of the study anthropometric measurements, basal respiratory function assessment, drugs, demographic information, allergen sensitivity, asthma control levels and quality of life scales will be documented. Patients will be randomly divided into two groups; one group following respiratory exercises and relaxation exercises and the other following only relaxation exercises. Both groups will be called regularly to remind the exercises.
The spirometric tests and asthma control forms will be reevaluated at the 3rd and 6th month at hospital.
Peak flow meters will be given to patients to document PEF values during study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Other: respiratory exercises, Other: relaxation exerciseschildren older than 10 years with a diagnosis of allergic asthma respiratory and relaxation exercises |
| Placebo group | Placebo comparator | Other: relaxation exerciseschildren older than 10 years with a diagnosis of allergic asthma only relaxation exercises |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 -
Key exclusion criteria (2 listed)
- asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders
- -
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 |
|---|---|---|
| respiratory exercisesrespiratory exercises | Other | Active group |
| relaxation exercisesrelaxation exercises | Other | Active group, Placebo group |
Primary outcome
Change in asthma attack frequency
Time frame: at third and sixth months
asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts
1 secondary outcome
Quality of life questionnaire
Time frame: at third and sixth months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Ayca Kiykim principal investigator
Istanbul University - Cerrahpasa
Hilal Denizoglu study chair
Atlas University
Hikmet Uçgun study chair
Atlas 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 respiratory exercises and relaxation exercises in people with Allergic Asthma, run by Istanbul University - Cerrahpasa 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 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayca Kiykim (+905423432245, ayca.kiykim@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma attack frequency (time frame: at third and sixth months). 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 1 Mar 2023.