Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106917652038 Date of Approval: 17/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Nebulized furosemide as adjunctive therapy in patients with stable chronic obstructive pulmonary disease : A randomized controlled trial
Official scientific title Nebulized furosemide as adjunctive therapy in patients with stable chronic obstructive pulmonary disease : A randomized controlled trial
Brief summary describing the background and objectives of the trial Chronic Obstructive Pulmonary Disease (COPD) is a progressive and persistent disease affecting public health concerns all over the world. It is the fourth cause of death and going to be the third cause of death by the end of 2030. COPD is a persistent disease that leads to a significant decline in lung functions, concerning morbidity and mortality characteristics. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is a well-known strategy for treating COPD but the current treatments are not stratifying for many types of COPD patients. However, nebulized furosemide is one of the adjunct therapy of COPD that may serve as a viable treatment solution. Furosemide nebulized researches focused on exacerbating COPD patients, only a few studies were done on stable COPD patients. Such studies are not enough as they did not deal with stable COPD as adjunctive therapy. This study intends to investigate the effect of adding nebulized furosemide to nebulized salbutamol-ipratropium nebulizer on FEV1, FVC, and FEV1/FVC in stable COPD patients (GOLD C and GOLD D).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2021
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Nebulized furosemide 4 ml of nebulized saline 0.9% for 10 minutes followed by 2ml of nebulized ipratropium 0.5 mg and 0.5ml of nebulized salbutamol 2.5mg for 10-15 minutes. 10 minutes 4 ml of nebulized saline 0.9% for 10 minutes followed by 2ml of nebulized ipratropium 0.5 mg and 0.5ml of nebulized salbutamol 2.5mg for 10-15 minutes. 50 Active-Treatment of Control Group
Experimental Group Nebulized normal saline 4 ml of nebulized furosemide 40 mg 10 minutes followed by 2ml of nebulized ipratropium 0.5mg and 0.5ml of nebulized salbutamol 2.5mg. 10 minutes 4 ml of nebulized furosemide 40 mg 10 minutes followed by 2ml of nebulized ipratropium 0.5mg and 0.5ml of nebulized salbutamol 2.5mg. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Stable (Not exacerbating) COPD patients documented by the pulmonologist - FEV1, FVC, (FEV1/FVC) less than 70% - Irreversible response to inhaled β-agonist (FEV1i ncrease <12% and <200 cc after15min from baseline) - Symptoms last about 5 years of breathlessness and, productive cough Patients with history of other lung diseases such as pneumonia, idiopathic pulmonary fibrosis, consolidation, congestive heart failure, exacerbated, asthma or asthma-COPD overlap. Smoking more than 15 packs/year using furosemide and other diuretics 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2021 Ethical Committee Medical Research Institute Alexandria University Egypt IORG0008812
Ethics Committee Address
Street address City Postal code Country
165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome forced expiratory volume/second (FEV1) after the first episode and after the second episode
Primary Outcome Forced vital capacity (FVC) after the first episode and after the second episode
Primary Outcome FEV1/FVC after the first episode and after the second episode
Secondary Outcome Modified Medical Research Council (mMRC) after the first episode and after the second episode
Secondary Outcome COPD assessment test (CAT) after the first episode and after the second episode
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Chest diseases. Faculty of Medicine Alexandria University Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reham Ragab Abd Rabbou Ali 165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Adel Zaki Abdel Sayed 6 Albert street, Somouha Alexandria 21646 Egypt
Alaa Eldeen Ali Abdallah Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
Gihan Mohamed Shehata 165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt
Asmaa Abdel Hameed Ahmed 165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt
Magda Alsayed Ibrahim 165 El-Horeya Rd, Al IbrahimeyahQebli WA Al HadrahBahri, Qesm Bab Sharqi Alexandria 21561 Egypt
Reham Ragab Abd Rabbou Ali 17 Mohammed El faham street, Ibrahimia Alexandria 21524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Zaki adelzakiok@yahoo.com 00201223289554 6 Albert street, Somouha
City Postal code Country Position/Affiliation
Alexandria 21646 Egypt Professor Medical statistics Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Reham Ali rere.hantery@gmail.com 00201146070685 17 Mohammed El faham street, Ibrahimia
City Postal code Country Position/Affiliation
Alexandria 21524 Egypt Biostatistician Medical statistics Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information