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
1 other identifier
observational
75
0 countries
N/A
Brief Summary
Chronic obstructive pulmonary disease is associated with systemic and local inflammation. exposure to harmful gases and particles play important role in initiating the inflammatory processes leading to the development of COPD. In high- and medium-income countries, tobacco smoking is considered the predominant source of these noxious elements.1 Asthma, COPD, rhinitis and rhinosinusitis (RS) are chronic diseases of the respiratory tract with an estimated global prevalence of about 12%.2The concept of united airways diseases (UAD) was formulated on the initial observation of the coexistence of allergic rhinitis and chronic rhinosinusitis with asthma.3
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 8, 2023
July 1, 2023
1 year
July 5, 2023
August 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
degree of Upper Airway inflammation and severity of COPD
patients with high UAD mostly affect degree of obstruction which assessed by FEV1 in PFT
1 year
Secondary Outcomes (1)
high UAD and severity of COPD togeher and impact on quality of life in those patients
1 year
Study Arms (2)
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
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
Interventions
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).
Eligibility Criteria
copd patients
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
July 5, 2023
First Posted
August 8, 2023
Study Start
September 1, 2023
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
August 8, 2023
Record last verified: 2023-07