BronchiectasisNCT05838144
Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis
A study testing Acapella device and Only routine chest physical therapy program in people with Bronchiectasis, run by South Valley University at 1 site in Egypt.
Trial summary
1. Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program . 2. Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Acapella device and Only routine chest physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 20 Oct 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- bronchiectasis patients.
- Age range between 40 to 55 years old of both gender.
- Cooperative patients.
Who cannot join
- Patients with severe cardiac disorders.
- Un controlled hypertensive patients.
- Un controlled diabetic patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Shymaa yussuf abo zaid
Cairo
Shymaa Y Abo zaid, 01010941685 ext. 01091631018, shaymaayoussef397@gmail.com
Shymaa Y Abo zaid, Doctoral
About this study
Official title: Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis.
- Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program .
- Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.
Read the detailed description
- Acapella group.Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program.
- Only routine physical therapy program group( control group). Will only take medications and routine chest physical therapy program Spirometer measures such as forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be measured for every patient before and after the end of 7 days.
- Conditions
- Bronchiectasis
- Being tested
- Acapella device, Only routine chest physical therapy program
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella deviceDevice
Group A. Will use Acapella device.
Only routine chest physical therapy programOther
Group B. Will take medications and perform routine chest physical therapy program.
| Study group | Role | What they receive |
|---|---|---|
| Acapella | Active comparator | Will use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program. Receives: Device: Acapella device; Other: Only routine chest physical therapy program |
| Only routine physical therapy program | Placebo comparator | Only they will receive medications and routine physical therapy program. Receives: Other: Only routine chest physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry measures
FVC, FEV1
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa yussuf abo zaid, South Valley University
- Investigators
- Shymaa Y Abo zaid, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838144
- Sponsor's protocol ID
- PT-IMG-02/2023-505
- Status last verified
- Jul 2023
- First submitted
- 24 Mar 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acapella on Spirometry Measures in Patients With Bronchiectasis.
- ClinicalTrials.gov ID
- NCT05838144
- Acronym / sponsor ID
- PT-IMG-02/2023-505
- Conditions
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 1 May 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.
- Acapella group. Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program .
- Only routine physical therapy program group ( control group). Will only take medications and routine chest physical therapy program.
Detailed description
- Acapella group.Will use Acapella device for 3 times per day for 15 minutes for 7 days beside medications and routine chest physical therapy program.
- Only routine physical therapy program group( control group). Will only take medications and routine chest physical therapy program Spirometer measures such as forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be measured for every patient before and after the end of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acapella | Active comparator | Device: Acapella device, Other: Only routine chest physical therapy programWill use Acapella device 3 times per day for 15 minutes for 7 days beside medications and routine physical therapy program. |
| Only routine physical therapy program | Placebo comparator | Other: Only routine chest physical therapy programOnly they will receive medications and routine physical therapy program. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- bronchiectasis patients.
- Age range between 40 to 55 years old of both gender.
- Cooperative patients.
Key exclusion criteria (3 listed)
- Patients with severe cardiac disorders.
- Un controlled hypertensive patients.
- Un controlled diabetic patients.
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 |
|---|---|---|
| Acapella deviceGroup A. Will use Acapella device. | Device | Acapella |
| Only routine chest physical therapy programGroup B. Will take medications and perform routine chest physical therapy program. | Other | Acapella, Only routine physical therapy program |
Primary outcome
Spirometry measures
Time frame: 7 days
FVC, FEV1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
Shymaa Y Abo zaid principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella device and Only routine chest physical therapy program in people with Bronchiectasis, run by South Valley 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 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 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. 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 Shymaa Y Abo zaid (01010941685 ext. 01091631018, shaymaayoussef397@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry measures (time frame: 7 days). 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 18 Jul 2023.