Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients

Copd Clinical Trial

Official title:

Inhaled Fenotereol,Ipratroium Plus Beclomethasone Versus Salmeterol,Tiotropium Plus Fluticasone in Frequent Excerbator COPD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05748977
• Other study ID #: SABA,SAMA versus LABA,LAMAcopd
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 20, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: nermen M abuelkassem, lecturer
• Phone: 01000767713
• Email: nermenabuelkassem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All frequent exacerabator copd patients

Exclusion Criteria:

• patients less than 18

Related Conditions & MeSH terms

• Copd

Intervention

Drug:
• SABA SAMA ICS Vs LABA LAMA ICs
Short acting agents,long acting agents ,ics

Locations

Country	Name	City	State
Egypt	Nermen Mohammed Abuelkassem	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess improvement of symptoms mainly dyspnea	to assess dyspnea in two groups by mMRC,saint gorge quetsonaire	1 year