Reactive Airway DiseasenasalfindingNCT03131323
Nasal Findings in Reactive Airway Diseases
An observational study of Reactive Airway Disease and Wheezing, run by Assiut University.
Trial summary
Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Reactive Airway Disease, Wheezing
- What is being tested?
- • Flexible fiberopticnasopharyngoscope
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jul 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged from 2years to 18 years with recurrent wheezy ches
Who may be able to join
- All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital
Who cannot join
- Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)
About this study
Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.Patients and methods:The study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital
Read the detailed description
Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. The worldwide increasing incidence of asthma continues to make it a global health problem . It is one of the major causes of hospitalization among children younger than 15 years of age . It carries a significant burden to children, their families, the healthcare system and the overall community. When combined with shortness of breath, chest tightness and/or cough, it is a bronchial asthma .
Pediatric wheeze be triggered by upper respiratory tract infections . The adenoids are a prominent contributor to chronic rhinitis in the pediatric population. Clinical control of chronic rhinosinusitis may be important to optimize the control of difficult-to-treat asthma. However, the relationship between chronic rhinosinusitis and asthma in children remains largely descriptive .
- Conditions
- Reactive Airway Disease, Wheezing
- Being tested
- • Flexible fiberopticnasopharyngoscope
- Keywords
- delineate the prevalence of abnormal nasal finding in wheezy child
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• Flexible fiberopticnasopharyngoscopeProcedure or surgery
.
II- Equipments:
- Flexible fiberopticnasopharyngoscope, 2.7 mm in diameter and fiberoptic light cable.
- The camera: fitted with Three-CCD (Charged Couple Device) sensors.
- A high resolution monitor.
- A recording unit. III- Positioning:Infants and small children have to be held by a parent or an adult. Older children and adolescents usually tolerate office flexible nasopharyngoscopy once the procedure is explained. If office flexible nasopharyngoscopy failed because the child is not cooperative or if there is excessive secretions, general anesthesia may be required [8].
IV- Technique: Lubricant gel will be applied to the tip of the endoscope which will be now will be passed along the floor of the nose, between the inferior turbinate and the nasal septum, till it reaches the nasopharynx. Now the entire nose and the nasopharynx could be thoroughly examined and any abnormal findings could be detected and documented.
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal findings in reactive airway diseases
the prevalence of abnormal nasal finding in wheezy children
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactive Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lamiaa mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131323
- Sponsor's protocol ID
- Assuit universit 17100106
- Acronym
- nasalfinding
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: children with age group 2years to 18 years will be obtained at the start of the study attenindin to emergency unit
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Findings in Reactive Airway Diseases
- ClinicalTrials.gov ID
- NCT03131323
- Acronym / sponsor ID
- nasalfinding / Assuit universit 17100106
- Conditions
- Reactive Airway Disease, Wheezing
- Keywords
- delineate the prevalence of abnormal nasal finding in wheezy child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 27 Apr 2017 (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.
Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.Patients and methods:The study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital
Detailed description
Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. The worldwide increasing incidence of asthma continues to make it a global health problem . It is one of the major causes of hospitalization among children younger than 15 years of age . It carries a significant burden to children, their families, the healthcare system and the overall community. When combined with shortness of breath, chest tightness and/or cough, it is a bronchial asthma .
Pediatric wheeze be triggered by upper respiratory tract infections . The adenoids are a prominent contributor to chronic rhinitis in the pediatric population. Clinical control of chronic rhinosinusitis may be important to optimize the control of difficult-to-treat asthma. However, the relationship between chronic rhinosinusitis and asthma in children remains largely descriptive .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged from 2years to 18 years with recurrent wheezy ches
Key inclusion criteria (1 listed)
- All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital
Key exclusion criteria (1 listed)
- Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)
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 |
|---|---|---|
| • Flexible fiberopticnasopharyngoscope. II- Equipments: * Flexible fiberopticnasopharyngoscope, 2.7 mm in diameter and fiberoptic light cable. * The camera: fitted with Three-CCD (Charged Couple Device) sensors. * A high resolution monitor. * A recording unit. III- Positioning:Infants and small children have to be held by a parent or an adult. Older children and adolescents usually tolerate office flexible nasopharyngoscopy once the procedure is explained. If office flexible nasopharyngoscopy failed because the child is not cooperative or if there is excessive secretions, general anesthesia may be required [8]. IV- Technique: Lubricant gel will be applied to the tip of the endoscope which will be now will be passed along the floor of the nose, between the inferior turbinate and the nasal septum, till it reaches the nasopharynx. Now the entire nose and the nasopharynx could be thoroughly examined and any abnormal findings could be detected and documented. | Procedure or surgery | – |
Primary outcome
nasal findings in reactive airway diseases
Time frame: one year
the prevalence of abnormal nasal finding in wheezy children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided. children with age group 2years to 18 years will be obtained at the start of the study attenindin to emergency unit
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reactive Airway Disease and Wheezing, 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 1 inclusion and 1 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 27 Apr 2017. 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?
nasal findings in reactive airway diseases (time frame: one year). 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 27 Apr 2017.