BronchiectasisNCT05034900
Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
A study testing Chest physiotherapy and Oscillatory Positive Expiratory Pressure (OPEP) device in people with Bronchiectasis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Chest physiotherapy and Oscillatory Positive Expiratory Pressure (OPEP) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 15 Sep 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of bronchiectasis
Who cannot join
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
Izmir
About this study
Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.
- Conditions
- Bronchiectasis
- Being tested
- Chest physiotherapy, Oscillatory Positive Expiratory Pressure (OPEP) device
- Keywords
- bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapyOther
Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.
Oscillatory Positive Expiratory Pressure (OPEP) deviceDevice
Shaker® device will be used.
| Study group | Role | What they receive |
|---|---|---|
| Chest Physiotherapy Group | Active comparator | Patients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes. Receives: Other: Chest physiotherapy |
| OPEP device + Chest Physiotherapy Group | Experimental | In addition to the same physiotherapy program applied to the controls, patients in this group will also use OPEP device two times a day, 7 days a week for 8 weeks at their homes. Receives: Other: Chest physiotherapy; Device: Oscillatory Positive Expiratory Pressure (OPEP) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Measured: 8 weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Measured: 8 weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Measured: 8 weeks
Change from baseline maximum minute ventilation at 8 weeks
Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test
Measured: 8 weeks
Change from baseline breathing reserve at 8 weeks
Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Measured: 8 weeks
Change from baseline six-minute walk distance at 8 weeks
Distance walked in six minutes will be recorded in six-minute walk test.
Measured: 8 weeks
Change from baseline M. Quadriceps strength at 8 weeks
- Quadriceps strength will be measured using hand-held dynamometer
Measured: 8 weeks
Change from baseline Leicester Cough Questionnaire score at 8 weeks
Questionnaire consists of 19 items covering physical, psychological and social domains of chronic cough with a 7 point likert response scale (range from 1 to 7). Higher score indicates better quality of life.
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 posted5 Sep 2021
- Study start6 Sep 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034900
- Sponsor's protocol ID
- bakircaymzeren05
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeren M, Barlik M, Tosun BNC, Demir E, Gulen F. Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Benefits in Children With Bronchiectasis?: A Randomized Trial. Pediatr Pulmonol. 2026 Apr;61(4):e71602. doi: 10.1002/ppul.71602.
PubMed 41914274
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?
- ClinicalTrials.gov ID
- NCT05034900
- Acronym / sponsor ID
- bakircaymzeren05
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, children, oscillatory positive expiratory pressure device, chest physiotherapy, pulmonary function, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 5 Sep 2021 (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.
Oscillatory positive expiratory pressure (OPEP) devices such as Flutter®, Aerobika® or Shaker ® are commonly prescribed in the clinical practice for airway clearance in children with chronic lung diseases including bronchiectasis, cystic fibrosis, and primary ciliary dyskinesia. Health insurance companies may cover these devices in some countries; but this is not a common practice around the world. Therefore, many families have to purchase these devices themselves. Unfortunately, these devices are rather expensive especially in the developing countries and consequently, families become financially burdened. Aim of this study is to investigate whether the addition of OPEP devices to a comprehensive chest physiotherapy program provide additional benefits on pulmonary function and exercise capacity in children with bronchiectasis. Results of this study may help better interpreting the cost-effectiveness of these devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest Physiotherapy Group | Active comparator | Other: Chest physiotherapyPatients in this group will perform comprehensive chest physiotherapy program two times a day, 7 days a week for 8 weeks at their homes. |
| OPEP device + Chest Physiotherapy Group | Experimental | Other: Chest physiotherapy, Device: Oscillatory Positive Expiratory Pressure (OPEP) deviceIn addition to the same physiotherapy program applied to the controls, patients in this group will also use OPEP device two times a day, 7 days a week for 8 weeks at their homes. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of bronchiectasis
Key exclusion criteria (2 listed)
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
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 |
|---|---|---|
| Chest physiotherapyProgramme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques. | Other | Chest Physiotherapy Group, OPEP device + Chest Physiotherapy Group |
| Oscillatory Positive Expiratory Pressure (OPEP) deviceShaker® device will be used. | Device | OPEP device + Chest Physiotherapy Group |
Primary outcome
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time frame: 8 weeks
Forced Vital Capacity (FVC) will be measured using Spiropalm 6MWT device
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time frame: 8 weeks
Forced Expiratory Volume in 1 second (FEV1) will be measured using Spiropalm 6MWT device
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time frame: 8 weeks
Peak Expiratory Flow (PEF) will be measured using Spiropalm 6MWT device
Change from baseline maximum minute ventilation at 8 weeks
Time frame: 8 weeks
Maximum minute ventilation will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline breathing reserve at 8 weeks
Time frame: 8 weeks
Breathing reserve will be measured using Spiropalm 6MWT device during six-minute walk test
Change from baseline six-minute walk distance at 8 weeks
Time frame: 8 weeks
Distance walked in six minutes will be recorded in six-minute walk test.
Change from baseline M. Quadriceps strength at 8 weeks
Time frame: 8 weeks
M. Quadriceps strength will be measured using hand-held dynamometer
Change from baseline Leicester Cough Questionnaire score at 8 weeks
Time frame: 8 weeks
Questionnaire consists of 19 items covering physical, psychological and social domains of chronic cough with a 7 point likert response scale (range from 1 to 7). Higher score indicates better quality of life.
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 16 Sep 2022.
- Derived from this study: PubMed 41914274Zeren M, Barlik M, Tosun BNC, Demir E, Gulen F. Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Benefits in Children With Bronchiectasis?: A Randomized Trial. Pediatr Pulmonol. 2026 Apr;61(4):e71602. doi: 10.1002/ppul.71602.
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Bronchiectasis
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 Chest physiotherapy and Oscillatory Positive Expiratory Pressure (OPEP) device in people with Bronchiectasis, run by Izmir Bakircay University 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: finished, as of the sponsor's last update on 16 Sep 2022. 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 from baseline Forced Vital Capacity (FVC) at 8 weeks (time frame: 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034900, which also lists 1 linked publication.
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 16 Sep 2022.