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Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05748977
Enrollment
80
Registered
2023-03-01
Start date
2023-02-20
Completion date
2024-03-20
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

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.

Interventions

DRUGSABA SAMA ICS Vs LABA LAMA ICs

Short acting agents,long acting agents ,ics

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All frequent exacerabator copd patients

Exclusion criteria

* patients less than 18

Design outcomes

Primary

MeasureTime frameDescription
to assess improvement of symptoms mainly dyspnea1 yearto assess dyspnea in two groups by mMRC,saint gorge quetsonaire

Countries

Egypt

Contacts

Primary Contactnermen M abuelkassem, lecturer
nermenabuelkassem@gmail.com01000767713
Backup Contactmohammed gamal Abdelrahman, lecturer
dr.mga2011@yahoo.com01026600071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026