Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients

NCT06377410 | Recruiting

• 1 other identifier: FF-2023-433
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 0.5-3.5 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 .

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.

  Participants with COPD who received either Syrup Prospan or N-Acetylcysteine

  From the time of randomization to the time of the end of study up to 30 days post randomization

Secondary Outcomes (6)

• to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.

  From the time of randomization to the time of the end of study up to 30 days post randomization

• to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry

  From the time of randomization to the time of the end of study up to 30 days post randomization

• to determine change of Forced Vital Capacity in litres/minute using spirometry

  From the time of randomization to the time of the end of study up to 30 days post randomization

• to determine adverse effects of Syrup Prospan (in %)

  From the time of randomization to the time of the end of study up to 30 days post randomization

• to determine adverse effects of N-Acetylcysteine (in %)

  From the time of randomization to the time of the end of study up to 30 days post randomization

Study Arms (2)

Participant with stable COPD who received Syrup prospan

ACTIVE COMPARATOR

Participant who fulfiled inclusion criteria with stable COPD and received Syrup prospan for 1 month

Drug: Syrup Prospan

Participant with stable COPD who received N-Acetylcysteine

ACTIVE COMPARATOR

Participant who fulfiled inclusion criteria with stable COPD and received SN-Acetylcysteine for 1 month

Drug: N-Acetylcysteine

Interventions

Syrup Prospan DRUG

Participant with stable COPD who received Syrup prospan for 1 month

Participant with stable COPD who received Syrup prospan

N-Acetylcysteine DRUG

Participant with stable COPD who received N-Acetylcysteine for 1 month

Participant with stable COPD who received N-Acetylcysteine

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with documented post bronchodilator FEV1/FVC \< 70 or \<LLN
• Age 40 years and above
• Able to perform spirometry
• Participant with Stable COPD based on GOLD 2023 strategy

You may not qualify if:

• Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
• Participants with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
• Hypersensitivity to acetylcysteine or any component of the formulation
• Hypersensitivity to dry powder ivy extract
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
• Participant on pre-existing regular mucolytics (at least 1 month prior)
• Illiterate participants

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (2)

National University of Malaysia, Faculty of Medicine

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

National University of Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

NOT YET RECRUITING

Related Publications (8)

• GBD 2017 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1859-1922. doi: 10.1016/S0140-6736(18)32335-3.

  PMID: 30415748 RESULT

• Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11.

  PMID: 19554195 RESULT

• Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.

  PMID: 16443707 RESULT

• Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC.

  PMID: 26151174 RESULT

• Garrard J, Rolnick SJ, Nitz NM, Luepke L, Jackson J, Fischer LR, Leibson C, Bland PC, Heinrich R, Waller LA. Clinical detection of depression among community-based elderly people with self-reported symptoms of depression. J Gerontol A Biol Sci Med Sci. 1998 Mar;53(2):M92-101. doi: 10.1093/gerona/53a.2.m92.

  PMID: 9520914 RESULT

• Poole P, Sathananthan K, Fortescue R. Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2019 May 20;5(5):CD001287. doi: 10.1002/14651858.CD001287.pub6.

  PMID: 31107966 RESULT

• Du Y, Wolf IK, Zhuang W, Bodemann S, Knoss W, Knopf H. Use of herbal medicinal products among children and adolescents in Germany. BMC Complement Altern Med. 2014 Jul 2;14:218. doi: 10.1186/1472-6882-14-218.

  PMID: 24988878 RESULT

• Balsamo R, Lanata L, Egan CG. Mucoactive drugs. Eur Respir Rev. 2010 Jun;19(116):127-33. doi: 10.1183/09059180.00003510.

  PMID: 20956181 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS (IIUM)

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Faisal Abdul Hamid, MBBS (IIUM)

CONTACT

0391455555; faisal.hamid@ppukm.ukm.edu.my

Mohamed FaisalM Abdul Hamid, MBBS (IIUM)

CONTACT

0391455555; faisal.hamid@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)