| CTRI Number |
CTRI/2015/09/006198 [Registered on: 18/09/2015] Trial Registered Retrospectively |
| Last Modified On: |
17/09/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
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Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
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Observational Study on cough syrup |
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Scientific Title of Study
|
Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination (FDC) of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| DRL/RPS/PMS/RCT/542/2015, Version 2.1, Date 15th April 2015 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Garg |
| Designation |
Medical Director - Emerging Market |
| Affiliation |
Dr Reddys Laboratories Ltd |
| Address |
Banjara Hills, Hyderabad
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
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| Fax |
|
| Email |
amitgarg@drreddys.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Sachin Aggrawal |
| Designation |
Clinical Trial Administrator |
| Affiliation |
QREC Clinical Research LLP |
| Address |
QREC Clinical Research, LLP
211, Arya Nagar, scheme No. 1
Alwar
RAJASTHAN
301001
India |
| Phone |
8527566768 |
| Fax |
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| Email |
drsachin.cro@qreccr.com |
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Source of Monetary or Material Support
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| Dr Reddys Laboratories Ltd, hyderabad |
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Primary Sponsor
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| Name |
Dr Reddys laboratories Ltd |
| Address |
Hyderabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debasis Basu |
Apollo Gleneagles Hopsital |
58, canal circular road, Dept. of Internal Medicine, kolkata
Kolkata
WEST BENGAL |
9831256906
drdbasu@gmail.com |
| Dr Kirit sisodiya |
BAPS Hopsital |
Dept. of Paedriatics, Surat
Surat
GUJARAT |
9879194433
kirtisisodiya@gmail.com |
| Dr Nirmal choraria |
Nirmal Hospital |
Dept. of Paedriatics, Surat
Surat
GUJARAT |
9825142549
drnchoraria@gmail.com |
| Dr Bharath venkata |
NMCH |
Dept. of Paedriatics,Nellore
Nellore
ANDHRA PRADESH |
8977864862
rvbharath@gmail.com |
| Dr Monidipa Banerjee |
Peerless Hospitex Hospital & Research Centre |
Dept. of Paedriatics, 360, panchasayar
Kolkata
WEST BENGAL |
03324622394
mondipa@hotmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| APOLLO Gleneagles Hospital |
Approved |
| BAPS pramukh swami hospital |
Approved |
| Nirmal hospital |
Approved |
| NMCH |
Approved |
| Peerless Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
productive cough (cough with expectoration) associated with any of the nasal symptoms (nasal discharge,nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between over 6 to 18 years of age
2. Male and female children
3. Children having productive cough (cough with expectoration)
associated with any of the nasal symptoms (nasal discharge,
nasal stuffiness, nasal itching, and Sneezing) since at least
previous 8 hours
4. Child willing to provide assent and parents/guardian willing
to provide written informed consent
5. Willing and able to understand and comply with all study
requirements |
|
| ExclusionCriteria |
| Details |
1. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 8 hours
2. Use of any "cold medication" (e.g. nasal or systemic decongestants, antihistamine, expectorant, anti-tussive) within last 8 hours
3. Severe cough requiring hospitalization
4. Presence of fever within last 8 hours
5. Active pulmonary disease such as bronchopneumonia, bronchial asthma or tuberculosis
6. Known allergy to and/or hypersensitivity to ambroxol and/or cetirizine
7. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
8. Use of any investigational therapy within 30 days prior to randomization
9. Child not willing to provide assent and parents/guardian not willing to provide written informed consent
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
1. Total Symptom Score (TSS) for cough would be sum total of four scores given below:
o Sputum volume,
o Sputum viscosity,
o Difficulty of expectoration, and
o Severity of cough
All above symptoms would be assessed on a 4-point scale |
1) 3rd day visit
2) 7th day visit |
|
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Secondary Outcome
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| Outcome |
TimePoints |
1. Total Nasal Symptom Score (TNSS) which is the sum total of scores for the following symptoms:
o Nasal discharge,
o Nasal stuffiness,
o Nasal itching, and
o Sneezing
2. Cough frequency (daily) assessed during follow-up visit
3. Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit
4. Time taken for complete cough relief (days) assessed during follow-up visit
|
3rd Day
7th day |
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Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
20/04/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Study Title - Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination FDC of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study
Research Objectives - 1. To assess the efficacy of therapy with fixed dose (FDC) combination of Cetirizine 5 mg plus Ambroxol 30 mg, and Ambroxol 30 mg monotherapy in controlling the symptoms of productive cough. 2. To assess the safety and tolerability of therapy with fixed dose (FDC) combination of Cetirizine 5 mg plus Ambroxol 30 mg, and Ambroxol 30 mg monotherapy in controlling the symptoms of productive cough.
Inclusion criteria: 1. Children between over 6 to 18 years of age 2. Male and female children 3. Children having productive cough (cough withexpectoration) associated with any of the nasal symptoms (nasal discharge, nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours 4. Child willing to provide assent and parents/guardian willing to provide written informed consent 5. Child requiring therapy with fixed dose FDC combination of Cetirizine 5 mg with Ambroxol 30 mg, OR Ambroxol 30 mg monotherapy as per the clinician’s discretion 6. Willing and able to understand and comply with all study requirements
Exclusion criteria: 1. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 8 hours 2. Use of any "cold medication" (e.g. nasal or systemic decongestants, antihistamine, expectorant, anti-tussive) within last 8 hours 3. Severe cough requiring hospitalization 4. Presence of fever within last 8 hours 5. Active pulmonary disease such as bronchopneumonia, bronchial asthma or tuberculosis 6. Known allergy to and/or hypersensitivity to ambroxol and/or cetirizine 7. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process 8. Use of any investigational therapy within 30 days prior to randomization 9. Child not willing to provide assent and parents/guardian not willing to provide written consent.
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