Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients

Early Phase 1

Not yet recruiting

• Conditions: Copd
• Interventions: Drug: SABA SAMA ICS Vs LABA LAMA ICs

• Registration Number: NCT05748977
• Lead Sponsor: Assiut University

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

Detailed Description

Aim of the work1.To compare efficacy of short acting beta 2 agonists ,short acting antimuscrinic agents and beclomethasone versus long acting beta 2 agonist,short acting antimuscurnic agents and fluticasone.- Type of the study: This study is a randomized controlled trail 2.4. 2- Study Setting: Present study will be conducted in chest outpatient clinic Chest department Assiut University hospital 2.4. 3- Study subjects: Frequent exacerbator COPD patients Based on determining the main outcome variable, the estimated minimum required sample size is 80 patients (40 in each group).

Main outcome variable is difference in dyspnoea scores in frequent exacerbator COPD patients receiving long-acting steroids vs. short acting treatment. Based on previous systematic review we expected to find significant improvement in long-acting treatment group (large effect size). Data will be collected through: patients diagnosed COPD by different investigations (history, examinations spirometry) have recurrent exacerbations, some patients receiving short acting beta 2 agonists, short acting anti-muscurnic agents and beclomethasone versus long acting agents and fluticasone then all patients followed using dyspnea scores, CCQ, saint George questionnaire which assess heath related quality of life.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-18
• Study Start: 2023-02-20
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-02-20
• Study Completion: 2024-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All frequent exacerabator copd patients

Exclusion Criteria

• patients less than 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SABA,SAMA ICS	SABA SAMA ICS Vs LABA LAMA ICs	-
LABA,LAMA ICS	SABA SAMA ICS Vs LABA LAMA ICs	-

Primary Outcome Measures

Name	Time	Method
to assess improvement of symptoms mainly dyspnea	1 year	to assess dyspnea in two groups by mMRC,saint gorge quetsonaire

Trial Locations

Locations (1)

Nermen Mohammed Abuelkassem; 🇪🇬 Assiut, Egypt