Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000344392
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
6/03/2017
Date last updated
2/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Propolis and N-Acetylcysteine Compared to Placebo in Adults in Acute Condition with Sputum Production
Scientific title
The Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Propolis and N-Acetylcysteine Compared to Placebo in Adults in Acute Condition with Sputum Production
Secondary ID [1] 290994 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 301758 0
Acute and chronic bronchitis 301759 0
Asthma 301760 0
Chronic obstructive pulmonary disease 302008 0
Bronchitis 302009 0
Condition category
Condition code
Respiratory 301652 301652 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study assessing the efficacy and safety of a combination of propolis and N-Acetylcysteine (PropoMucil 600, Abela Pharm; 80mg propolis+600mg NAC) versus placebo in patients with asthma or COPD or bronchitis, with productive cough, one sachet of powder (3g), once daily for a period of 10 days (sachet will be prepared prior to administration, each sachet dissolved in 125ml (1/4 pint) of water.). A prospective, randomized, double-blind, placebo-controlled study will include 100 consecutive patients.
Empty, used, sachets must returned at the end of the treatment to the study site.
Intervention code [1] 296951 0
Treatment: Drugs
Intervention code [2] 297142 0
Rehabilitation
Comparator / control treatment
1. PropoMucil 600 (80mg propolis + 600mg NAC), one sachet of powder (3g) orally, once daily for a period of 10 days.
2. Placebo (microcrystalline cellulose).
Control group
Placebo

Outcomes
Primary outcome [1] 300847 0
Each patient will be assessed by expectorated amount of sputum (ml) by participant diary and collected by container for sputum
Timepoint [1] 300847 0
Baseline, and 10 days after end of therapy
Primary outcome [2] 300848 0
Determined the patient’s markers of inflammation (by measuring the C-reactive protein (CRP), fibrinogen and erythrocyte sedimentation rate (ESR)) from the blood samples (by serum assay), as composite primary outcome.
Timepoint [2] 300848 0
Baseline, and 10 days after end of therapy
Secondary outcome [1] 331013 0
Patients` compliance using by participant diary
Timepoint [1] 331013 0
At end of 10 day treatment period
Secondary outcome [2] 331014 0
Cough effect on the quality of life through LEICESTER COUGH QUESTIONNAIRE-acute (LCQ-acute)
Timepoint [2] 331014 0
Baseline and 10 days after end of therapy
Secondary outcome [3] 331574 0
Safety of product reported by questionnaire (fill it out for each of patient), special questionnaire created for the purpose of research
Timepoint [3] 331574 0
10 days after end of therapy

Eligibility
Key inclusion criteria
1. Subjects are between the age of 18 and 85 with acute exacerbation of chronic obstructive pulmonary disease (COPD), acute and chronic bronchitis or asthma who have chest symptoms such as cough and sputum production (particularly increased breathlessness and cough, and increased sputum), treating with conventional therapy (corticosteroid and antibiotics)
2. Gender: both males and females
3. Informed, written consent will be obtained from all respondents (patients)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. status asthmaticus
2. history of stomach or duodenal ulcer
3. <18 years of age
4. patients who are sensitive to NAC and propolis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed, by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomly allocated to the two study arms using simple randomisation procedures like coin-tossing. Groups will be matched by age, gender and diagnostic criteria.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/03/2017
Actual
21/03/2017
Date of last participant enrolment
Anticipated
11/04/2017
Actual
2/10/2017
Date of last data collection
Anticipated
17/04/2017
Actual
13/10/2017
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8604 0
Serbia and Montenegro
State/province [1] 8604 0
Serbia

Funding & Sponsors
Funding source category [1] 295418 0
Commercial sector/Industry
Name [1] 295418 0
Abela Pharm
Country [1] 295418 0
Serbia and Montenegro
Primary sponsor type
Commercial sector/Industry
Name
Abela Pharm
Address
Viline vode bb, 11000 Belgrade
Country
Serbia and Montenegro
Secondary sponsor category [1] 294236 0
Hospital
Name [1] 294236 0
Municipal Institute for Lung Diseases and Tuberculosis
Address [1] 294236 0
Presevska 35, 11000 Belgrade
Country [1] 294236 0
Serbia and Montenegro

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296750 0
Ethics committee of Municipal Institute for Lung Diseases and Tuberculosis
Ethics committee address [1] 296750 0
Presevska 35
11000 Belgrade
Ethics committee country [1] 296750 0
Serbia and Montenegro
Date submitted for ethics approval [1] 296750 0
10/10/2016
Approval date [1] 296750 0
17/10/2016
Ethics approval number [1] 296750 0
5422/1

Summary
Brief summary
Efficacy and safety of a combination of propolis and N-Acetylcysteine (NAC); (PropoMucil 600 manufactured by Abela Pharm, Serbia) versus placebo in patients with asthma or COPD, and productive cough for a period of 10 days as measured by the amount of sputum, cough impact on the patient, parameters of inflammation (C-reactive protein, erythrocyte sedimentation rate).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71950 0
Dr Dejan Zujovic
Address 71950 0
Municipal Institute for Lung Diseases and Tuberculosis
Presevska 35
11000 Belgrade
Serbia
Country 71950 0
Serbia and Montenegro
Phone 71950 0
+38165 2230220
Fax 71950 0
Email 71950 0
[email protected]
Contact person for public queries
Name 71951 0
Anita Agic
Address 71951 0
Abela Pharm
Viline vode bb
11000 Belgrade
Serbia
Country 71951 0
Serbia and Montenegro
Phone 71951 0
+38163204797
Fax 71951 0
Email 71951 0
[email protected]
Contact person for scientific queries
Name 71952 0
Dejan Zujovic
Address 71952 0
Municipal Institute for Lung Diseases and Tuberculosis
Presevska 35
11000 Belgrade
Serbia
Country 71952 0
Serbia and Montenegro
Phone 71952 0
+38165 2230220
Fax 71952 0
Email 71952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.