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BronchoscopyNCT04208607

Role of Bronchoscopy in Bronchiectasis

A study testing Bronchoscopy in people with Bronchoscopy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Role of bronchoscopy in diagnosis of bronchiectasis in to different types Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Bronchoscopy
What is being tested?
Bronchoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Dec 2019to Dec 2020
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients more than 18 years
  • Patients less than 70 years
  • Patients with bronchiectasis

Who cannot join

  • patients with bronchial asthma or chronic obstructive pulmonary disease
  • patients with pneumonia
  • patients with T.B

About this study

Official title: Bronchiectasis Phenotypes ; Clinical , Radiological and Microbiological Assesment

Role of bronchoscopy in diagnosis of bronchiectasis in to different types

Read the detailed description

Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients have a structural abnormality of the bronchial wall that predisposes them to bacterial infection likely due to impaired mucus clearance. A self-perpetuating vicious cycle of chest infections and chronic lung inflammation can lead to further damage of the bronchial wall and spread of disease to normal areas of bystander lung.(1)( Wilson et al,1997).

A search for an underlying cause, which may be amenable to a targeted intervention to prevent ongoing damage, is essential but often fruitless, and the focus of therapy rapidly turns to empiric treatments to prevent infective exacerbations and retard disease progression. (2) ( Martinez-Garcia, et al,2005 ) The British Thoracic Society bronchiectasis management guidelines provide an in-depth summary of the available literature and are an excellent tool for guiding treatment decision making. However, they do not provide guidance on which patients are most likely to benefit from specific interventions. (3) (Pasteur et al, 2010).

Disease severity in bronchiectasis is hard to define. Radiological severity grading scores exist; however, there is often a disconnect between radiological severity, symptom burden and disease progression (4) (Eshed et al, 2007).

In 2014, competing bronchiectasis severity scores were published (FACED and the Bronchiectasis Severity Index (BSI). In each of these, a combination of patient demographics, symptom scores, comorbidities, and clinical, radiological and microbiological parameters were used to construct scoring systems, which, in the case of the BSI, predicted future mortality, and in the case of FACED, extended to prediction of future exacerbation frequency, hospitalisation and quality of life. (5, 6) (Chalmers et al, 2014; Martinez-Garcia et al, 2014).

These severity scores have utility in identifying an individual's risk of disease progression to a predefined outcome and aid in subclassifying this heterogeneous group of patients in a manner that may pave the way to future mechanistic studies, which explain how these different disease phenotypes arise and inform the development of targeted therapeutics. (7) (Aliberti et al, 2007).

Conditions
Bronchoscopy
Being tested
Bronchoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BronchoscopyProcedure or surgery

    Role of bronchoscopy in diagnosis of bronchiectasis

Study groups in NCT04208607
Study groupRoleWhat they receive
Study groupExperimentalPatients with bronchiectasis
Receives: Procedure: Bronchoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of bronchiectatic patients with pseudomonal infection

    Bronchoscopy will be done to all patients and bronchoalveolar lavage will be taken

    Measured: One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study startDec 2019 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208607
Sponsor's protocol ID
Bronchoscopy in bronchiectasis
Status last verified
Dec 2019
First submitted
21 Sep 2019
Last updated
23 Dec 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Bronchoscopy in people with Bronchoscopy, run by Assiut University.

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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Percentage of bronchiectatic patients with pseudomonal infection (time frame: One week). 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 23 Dec 2019.

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