NCT05748977

Brief Summary

Chronic obstructive pulmonary disease is heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive ,airflow obstruction. There are network meta analysis to compare the efficacy and safety of short acting bronchodilators Vs long acting agents in treatment of COPD

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

February 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

February 18, 2023

Last Update Submit

February 28, 2023

Conditions

Copd

Outcome Measures

Primary Outcomes (1)

  • to assess improvement of symptoms mainly dyspnea

    to assess dyspnea in two groups by mMRC,saint gorge quetsonaire

    1 year

Study Arms (2)

SABA,SAMA ICS

EXPERIMENTAL
Drug: SABA SAMA ICS Vs LABA LAMA ICs

LABA,LAMA ICS

EXPERIMENTAL
Drug: SABA SAMA ICS Vs LABA LAMA ICs

Interventions

SABA SAMA ICS Vs LABA LAMA ICsDRUG

Short acting agents,long acting agents ,ics

LABA,LAMA ICSSABA,SAMA ICS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All frequent exacerabator copd patients

You may not qualify if:

  • patients less than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nermen Mohammed Abuelkassem

Asyut, 71511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • nermen M abuelkassem, Lecturer

    MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

nermen M abuelkassem, lecturer

CONTACT

01000767713nermenabuelkassem@gmail.com

mohammed gamal Abdelrahman, lecturer

CONTACT

01026600071dr.mga2011@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

February 20, 2023

Primary Completion

February 20, 2024

Study Completion

March 20, 2024

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

EG(1)