Non Cystic Fibrosis BronchiectasisNCT07722364
HFCWO in Children With Non-CF Bronchiectasis
A study testing High Frequency Chest Wall Oscillation and conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. in people with Non Cystic Fibrosis Bronchiectasis, run by Sphinx university at 1 site in Egypt.
Trial summary
the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Non Cystic Fibrosis Bronchiectasis
- What is being tested?
- High Frequency Chest Wall Oscillation and conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
- 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
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children with no cystic fibrosis bronchiectasis
- Both sexes
- Their ages ranges from 6-12 years
- After 48 hours of attack, if hemoptysis or fever not found
Who cannot join
- • Osteoporosis (Calcium deficiency)
- Bleeding tendency
- Recent surgery of brain, eye, thoracic, or neck surgery
- Pneumothorax
- Cystic fibrosis bronchiectasis
- Pulmonary embolism
- Rib fracture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
pediatric hospital, Assiut university
Asyut
Marwa elkawy, Msc, 01030077626, marwa.elkawy2018@yahoo.com
About this study
Official title: Effect of High Frequency Chest Wall Oscillation on Pulmonary Functions in Children With Non-Cystic Fibrosis Bronchiectasis
the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis
Read the detailed description
The purpose of this study is to evaluate the effect of using HFCWO intervention on pulmonary functions in children with bronchiectasis.
it hypothesized that Using HFCWO has no effect on pulmonary functions and hospital stay in children with bronchiectasis.
Children subjected to the inclusion criteria will be assigned randomly into two groups, control group and study group.
Does high frequency chest wall oscillation (HFCWO) have an effect in pulmonary functions in children with bronchiectasis? RCT study Control group Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
Study group This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect.
outcome measure: FEV1, FVC, FEV1/FVC quality of life for bronchiectasis, 6-minute walk test
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Being tested
- High Frequency Chest Wall Oscillation, conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
- Keywords
- HFCWO, cystic fibrosis, bronchiectasis
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Chest Wall OscillationDevice
High-frequency chest wall oscillation that applies external chest wall oscillations via an inflatable vest worn around the thoracic cage, increasing the air-liquid shear forces during expiration is believed to result in secretion mobilization.
The product name that will be used is Air Way Clearness system; his model is PV-900/ PV-300/PV-100, made in China.
conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.Other
conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
Conventional physiotherapy that will be applied to the control group for 30 minutes will include:
- Postural drainage according to accumulation of secretions for 10 minutes accompanied by percussion or vibration
- Active cycle breathing technique (ACBT) for 10 minutes
- Respiratory exercises for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr | Experimental | This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect. Receives: Device: High Frequency Chest Wall Oscillation |
| children who will be treated by conventional physiotherapy program | Active comparator | Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. Receives: Other: conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Change in FEV1 measured by spirometry according to ATS/ERS guidelines
Measured: Baseline and after 8 weeks of treatment
Forced Vital Capacity (FVC)
Change in FVC measured by spirometry according to ATS/ERS guidelines
Measured: Baseline and after 6 months of treatment
FEV1/FVC Ratio
Change in FEV1/FVC ratio measured by spirometry according to ATS/ERS guidelines
Measured: Baseline and after 6 months of treatment
Secondary outcomes (1)
Six-Minute Walk Distance (6MWD)
hange in functional exercise capacity assessed by the Six-Minute Walk Test (6MWT). The total distance walked in six minutes is recorded according to the American Thoracic Society (ATS) guidelines.
Measured: Baseline and after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Cystic Fibrosis 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sphinx university
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa El-kawy Ghait Mohamed, Sphinx university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722364
- Sponsor's protocol ID
- HFCWO and bronchectasis
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Frequency Chest Wall Oscillation on Pulmonary Functions in Children With Non-Cystic Fibrosis Bronchiectasis
- ClinicalTrials.gov ID
- NCT07722364
- Acronym / sponsor ID
- HFCWO and bronchectasis
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Keywords
- HFCWO, cystic fibrosis, bronchiectasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sphinx universityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Jul 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.
the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis
Detailed description
The purpose of this study is to evaluate the effect of using HFCWO intervention on pulmonary functions in children with bronchiectasis.
it hypothesized that Using HFCWO has no effect on pulmonary functions and hospital stay in children with bronchiectasis.
Children subjected to the inclusion criteria will be assigned randomly into two groups, control group and study group.
Does high frequency chest wall oscillation (HFCWO) have an effect in pulmonary functions in children with bronchiectasis? RCT study Control group Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
Study group This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect.
outcome measure: FEV1, FVC, FEV1/FVC quality of life for bronchiectasis, 6-minute walk test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr | Experimental | Device: High Frequency Chest Wall OscillationThis group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group. The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect. |
| children who will be treated by conventional physiotherapy program | Active comparator | Other: conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Children with no cystic fibrosis bronchiectasis
Key exclusion criteria (7 listed)
- • Osteoporosis (Calcium deficiency)
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 |
|---|---|---|
| High Frequency Chest Wall OscillationHigh-frequency chest wall oscillation that applies external chest wall oscillations via an inflatable vest worn around the thoracic cage, increasing the air-liquid shear forces during expiration is believed to result in secretion mobilization. The product name that will be used is Air Way Clearness system; his model is PV-900/ PV-300/PV-100, made in China. | Device | children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr |
| conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. Conventional physiotherapy that will be applied to the control group for 30 minutes will include: * Postural drainage according to accumulation of secretions for 10 minutes accompanied by percussion or vibration * Active cycle breathing technique (ACBT) for 10 minutes * Respiratory exercises for 10 minutes | Other | children who will be treated by conventional physiotherapy program |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Baseline and after 8 weeks of treatment
Change in FEV1 measured by spirometry according to ATS/ERS guidelines
Forced Vital Capacity (FVC)
Time frame: Baseline and after 6 months of treatment
Change in FVC measured by spirometry according to ATS/ERS guidelines
FEV1/FVC Ratio
Time frame: Baseline and after 6 months of treatment
Change in FEV1/FVC ratio measured by spirometry according to ATS/ERS guidelines
1 secondary outcome
Six-Minute Walk Distance (6MWD)
Time frame: Baseline and after 6 months of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Chest Wall Oscillation and conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. in people with Non Cystic Fibrosis Bronchiectasis, run by Sphinx 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 7 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: opening soon, as of the sponsor's last update on 28 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa elkawy, Msc (01030077626, marwa.elkawy@sphinx.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in 1 second (FEV1) (time frame: Baseline and after 8 weeks of treatment). The study lists 3 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 28 Jul 2026.