- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980611
Nasal IL 1 Beta ,IL 3 Level and Their Effects in COPD Patients
Evaluation of Nasal IL 1 Beta ,IL 3 Level and Their Effects on Disease Severity in COPD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
. COPD patients asscioted with upper airway disease either high symptoms or low symptoms according to The 22-item Sino Nasal Outcome Test .Data will be collected through: History and examination of the upper airways and COPD symptomatology. History of smoking, medication, admission and acute exacerbation . Pulmonary function tests to confirm diagnosis and degree of obstruction. Diagnosis of COPD will be confirmed by the presence of irreversible airflow obstruction, post-bronchodilator FEV1/FVC ratio of less than 0.7. Severity of airflow obstruction will be graded according to the GOLD criteria [9] using CAT questionnaire to assess degree of COPD burden.[10] The 22-item Sino Nasal Outcome Test (SNOT22) will assess chronic rhinosinusitis symptoms and includes nasal and more general symptoms such as fatigue [11]. Each symptom is scored from 0 (no symptoms) to 5 (symptoms as bad as they can be"). The maximum score is 110, with an MCID of 9 points [12].
The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell or taste", "post-nasal discharge" and "thick nasal discharge". A cut-off for normality (or MCID) has been not validated, however the total SNOT22 has been found to have a median score of 7 points in healthy volunteers [12] Clinical markers in COPD symptom severity: Dyspnea will be graded using the mMRC 5-point scale.13 Physical Activity The 6MWD will be measured in accordance with the standard protocol with modifications.14 The latter were a shorter walking lap of 50 m instead of 60 m . Participants rested for 10 min before the test and then followed a straight corridor with a length of 25 m which was marked every 5 m. The turnaround points were set up with a red cone, and the distance walked in 6 minutes was recorded. Standardized phrases of encouragement were given during the test. Disease-specific HRQoL for COPD was measured by the CAT and the SGRQ questionnaires. The range of the total score is from 0 to 40 for the former and from 0 to 100 for the latter questionnaire, and high scores are indicative of poorer HRQoL
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nermen mohamed abuelkassem, lecturer
- Phone Number: 01000767713
- Email: nermenabuelkassem@gmail.com
Study Contact Backup
- Name: Maha Ali Essameldeen, lecturer
- Phone Number: 01091570963
- Email: Mahaali@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:We included patients according to the following inclusion criteria:
- age ≥ 40 years
- History of smoking > ten pack-years of tobacco
- Post- bronchodilator Forced Expiratory Volume 1 s (FEV1)/Forced Vital Capacity (FVC) index <0.70.
Exclusion Criteria:self-reported or physician- diagnosed asthma and reversibility for beta 2 agonist above 400 ml and 15% from baseline FEV1
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
copd patients with high upper airway symptoms
The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no.
1-5 + 7-8), which include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell or taste", "post-nasal discharge" and "thick nasal discharge".
the total SNOT22 has been found to have a median score of 7 points in healthy volunteers
|
Interleukin (IL)-1-beta and IL-3 will be measured in patients' serum and supernatant from the nasal swap using enzyme linked immunosorbent assay (ELISA).
|
copd patients with low upper airway symptoms
The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no.
1-5 + 7-8), which include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell or taste", "post-nasal discharge" and "thick nasal discharge".
the total SNOT22 has been found to have a median score of 7 points in healthy volunteers
|
Interleukin (IL)-1-beta and IL-3 will be measured in patients' serum and supernatant from the nasal swap using enzyme linked immunosorbent assay (ELISA).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
degree of Upper Airway inflammation and severity of COPD
Time Frame: 1 year
|
patients with high UAD mostly affect degree of obstruction which assessed by FEV1 in PFT
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
high UAD and severity of COPD togeher and impact on quality of life in those patients
Time Frame: 1 year
|
patients with copd and nasal involvement and quality of life by using saint george questionnaire
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- nasal IL B,IL 3 ,COPD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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