Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377410
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-31
Brief Title:
Efficacy Safety of Dry Powder Ivy Extract Syrup Prospan Versus NAC Among COPD Patients
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
A Randomised Open Label Interventional Study Evaluating the Efficacy Safety of Dry Powder Ivy Extract Syrup Prospan Versus NAC Among COPD Patients SyProNAC Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SyProNAC
Brief Summary:
As the third global leading cause of death Chronic Obstructive Pulmonary Disease COPD affects more than 300 million people worldwide These patients suffer from 05-35 exacerbations per year on average Each exacerbations dampened their health status as well as quality of life not to mention a great burden to our healthcare system Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression Hence a holistic approach in managing each exacerbations is very crucial
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes These exacerbations comes with sputum increment as much as its purulence Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation
Mucolytics work by reducing sputum viscosity hence improved its expectoration N-acetylcysteine NAC is a mucolytic with antioxidant and anti-inflammatory properties commonly used in practice among COPD patients Meanwhile Syrup Prospan is ivy leaf preparations obtained as extracts from leaves of the plant Hedera helix L It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties Studies show evidence of antispasmodic bonchodilating anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes These exacerbations comes with sputum increment as much as its purulence Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation
Mucolytics work by reducing sputum viscosity hence improved its expectoration N-acetylcysteine NAC is a mucolytic with antioxidant and anti-inflammatory properties commonly used in practice among COPD patients Meanwhile Syrup Prospan is ivy leaf preparations obtained as extracts from leaves of the plant Hedera helix L It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties Studies show evidence of antispasmodic bonchodilating anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency
Detailed Description:
Hypothesis
1 Syrup Prospan is non inferior to NAC - no significant difference of cough symptoms and its impact on daily activities health related quality of life as well as lung function test at 30 days of treatment
2 Patients received Syrup Prospan has higher satisfaction score compared to N-Acetylcysteine
This is a randomised open label interventional study evaluating the efficacy and safety of dry powder Ivy Extract Syrup Prospan versus NAC among COPD patients Randomization 11 to received either NAcetylcysteine 600 mg BD or Syrup Prospan 75mls BD Block randomization
The study will be conducted from April 2024 to November 2026 This is a prospective interventional study conducted on COPD patients under the Respiratory Unit Department of Internal Medicine in HCTM who qualified both the inclusion and exclusion criteria Patients will be briefed about this study
Subsequently consent will be obtained from those who are agree to participate from the patient himherself
Participants will be assessed first with several modalities particularly spirometry CAT score McGill COPD Quality of Life and Cough and Sputum Assessment Questionnaire CASA-Q prior to the commencement of treatmentParticipants will be seen on Day 15 to evaluate patients adherence compliance as well as adverse effect Then patients will be assessed again on Day 30 of treatment with the same set of evaluation tools as in the beginning of the study
In order to calculate the required sample size we will employ the Cohens d formula for estimating the effect size Cohen 1988 19 The formula is given as
Where d is the Cohens effect size M1 and M2 are the mean for the first and second group and SD1 and SD2 are the standard deviation for the first and second group respectively
Based on a previous study which employs the CAT score to assess the efficacy of NAC in patients with COPD the mean and standard deviation for before and after treatment are given as
Before treatment 2346 366 After treatment 2038 578
Hence this give the values of M1 2346 and M2 2038 and SD1 366 and SD2 578 that can use to estimate the effect size using the formula above
Therefore it gives an estimated effect size of 0637 which is considered to be a medium effect size
With a power of 80 and a level of significance of 5 for detecting an effect size of 0637 we calculate the required sample size using an online sample size calculator for comparing paired differences It gives at a value of 23 participants for each group which mean the required number of participants is 46
Additional of 20 samples is recruited to avoid missing data due to withdrawal or drop out Therefore a total of minimum 55 patients will be recruited for this study However we aim to recruit 100 patients for our study where the treatment is given to equal number of participants in each group
1 Syrup Prospan is non inferior to NAC - no significant difference of cough symptoms and its impact on daily activities health related quality of life as well as lung function test at 30 days of treatment
2 Patients received Syrup Prospan has higher satisfaction score compared to N-Acetylcysteine
This is a randomised open label interventional study evaluating the efficacy and safety of dry powder Ivy Extract Syrup Prospan versus NAC among COPD patients Randomization 11 to received either NAcetylcysteine 600 mg BD or Syrup Prospan 75mls BD Block randomization
The study will be conducted from April 2024 to November 2026 This is a prospective interventional study conducted on COPD patients under the Respiratory Unit Department of Internal Medicine in HCTM who qualified both the inclusion and exclusion criteria Patients will be briefed about this study
Subsequently consent will be obtained from those who are agree to participate from the patient himherself
Participants will be assessed first with several modalities particularly spirometry CAT score McGill COPD Quality of Life and Cough and Sputum Assessment Questionnaire CASA-Q prior to the commencement of treatmentParticipants will be seen on Day 15 to evaluate patients adherence compliance as well as adverse effect Then patients will be assessed again on Day 30 of treatment with the same set of evaluation tools as in the beginning of the study
In order to calculate the required sample size we will employ the Cohens d formula for estimating the effect size Cohen 1988 19 The formula is given as
Where d is the Cohens effect size M1 and M2 are the mean for the first and second group and SD1 and SD2 are the standard deviation for the first and second group respectively
Based on a previous study which employs the CAT score to assess the efficacy of NAC in patients with COPD the mean and standard deviation for before and after treatment are given as
Before treatment 2346 366 After treatment 2038 578
Hence this give the values of M1 2346 and M2 2038 and SD1 366 and SD2 578 that can use to estimate the effect size using the formula above
Therefore it gives an estimated effect size of 0637 which is considered to be a medium effect size
With a power of 80 and a level of significance of 5 for detecting an effect size of 0637 we calculate the required sample size using an online sample size calculator for comparing paired differences It gives at a value of 23 participants for each group which mean the required number of participants is 46
Additional of 20 samples is recruited to avoid missing data due to withdrawal or drop out Therefore a total of minimum 55 patients will be recruited for this study However we aim to recruit 100 patients for our study where the treatment is given to equal number of participants in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None