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CTRI Number  CTRI/2009/091/000112 [Registered on: 25/03/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the evaluation of efficacy, safety and tolerability of three expectorants in the treatment of productive cough associated with acute bronchitis, AECB, pneumonia and asthmatic bronchitis in Indian population  
Scientific Title of Study   TO COMPARE THE EVALUATION OF EFFICACY, SAFETY AND TOLERABILITY OF COMBINATION OF SALBUTAMOL 2 mg + BROMHEXINE HCI 8 mg + GUAIFENESIN 100 mg (ASCORIL EXPECTORANT VS SALBUTAMOL 2 mg + GUAIFENESIN 100 mg EXPECTORANT VS SALBUTAMOL 2 mg + BROMHEXINE HCI 8 mg IN THE TREATMENT OF PRODUCTIVE COUGH ASSSOCIATED WITH ACUTE BRONCHITIS, AECB, PNEUMONIA AND ASTHMATIC BRONCHITIS IN INDIAN POPULATION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GP/01/08  Other 
GP/01/08  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Akhilesh Sharma 
Designation   
Affiliation   
Address  Glenmark Pharmaceuticals Ltd
BD Sawant Marg, Chakala, Andheri East
Mumbai
MAHARASHTRA
400099
India 
Phone  91-22-40189999  
Fax  91-22-40189990  
Email  akhileshs@glenmarkpharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Akhilesh Sharma 
Designation   
Affiliation  Medical Services 
Address  Glenmark Pharmaceuticals Ltd
BD Sawant Marg, Chakala, Andheri East
Mumbai
MAHARASHTRA
400099
India 
Phone  91-22-40189999  
Fax  91-22-40189990  
Email  akhileshs@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Akhilesh Sharma 
Designation   
Affiliation   
Address  Glenmark Pharmaceuticals Ltd
BD Sawant Marg, Chakala, Andheri East
Mumbai
MAHARASHTRA
400099
India 
Phone  91-22-40189999  
Fax  91-22-40189990  
Email  akhileshs@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. Mumbai 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd BD Sawant Marg, Chakala, Off. Western Express Highway, Andheri (E), Mumbai 400 099  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Prabhu Shankar  Arupadai Veedu Medical College and Hospital  Cuddalore Main Road,-607402
Pondicherry
PONDICHERRY 
91-9894835015

dr.prabhumd@yahoo.com 
Dr N T Awad  Kastur Mahal Polyclinic  C-3, Kastur Mahal Bldg, Plot No 9,,Sion West-400022
Mumbai
MAHARASHTRA 
91-22-24073941

drntawad@hotmail.com 
Dr S Chandrasekharan  Sooriya Hospital  1, Arunachalam Road, ,Saligramam-600093
Chennai
TAMIL NADU 
91-44-28275832

schan2004@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
East Coast Hospital  Approved 
Path Independant Ethics Committee  Approved 
Sooriya Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Productive Cough associated with Acute Bronchitis, AECB, Pneumonia and Asthmatic Bronchitis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Expectorant combination of Salbutamol 2mg + Bromhexine HCl 8 mg + Guaifenesin 100 mg  5ml three times a day for 7 days 
Comparator Agent  Salbutamol 2 mg + Bromhexine 8 mg  5 ml three timesa day for 7 days 
Comparator Agent  Salbutamol 2 mg + Guaifenesin 100 mg expectorant   5 ml three tiimes a day for 7 days 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Patients of either sex 18-65 years 2. Subjects giving written informed consent 3. Patients with Productive Cough associated with Acute Bronchitis, AECB, Pneumonia and Asthmatic Bronchitis 4. In the opinion of the investigator, able to comply with the requirements of the protocol.  
 
ExclusionCriteria 
Details  1. Patients with Cystic Fibrosis 2. Patients with Active Tuberculosis 3. Patients with lung cancer or lung metastasis 4. Patients with severe bronchiectasis 5. Patients with acute respiratory decompensation 6. Patients with Chronic respiratory insufficiency associated with resting hypoxemia, 7. Patients requiring hospitalization for parenteral antibiotic treatment 8. Patients with hypersensitivity against the medication under study 9. Patients with Female patients with child bearing potential- Who are pregnant Who are breastfeeding Who are not practicing acceptable methods of birth control  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the change in consistency of sputum between the test and reference drugs  End of study 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the change in volume of sputum, frequency and severity of cough, breathlessness from baseline and between the groups.  End of study 
 
Target Sample Size   Total Sample Size="354"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/05/2008 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The present one-week, multicentric, prospective, randomized, double-blind study compared the efficacy and tolerability of three expectorant formulations in 426 patients with productive cough associated with varied aetiology after approval by the institutional review boards. Selected patients received 7 days treatment with either fixed dose combination (FDC)of Salbutamol 2mg + Bromhexine HCl 8mg + Guaifenesin100 mg(Group A) or Salbutamol 2mg+ Guaifenesin100 mg Expectorant(Group B) or Salbutamol 2mg + Bromhexine 8mg (Group C) thrice daily after obtaining their informed consent. In Group A, there was improvement of symptoms in a larger number of patients and earlier onset of action in reducing cough frequency and severity and improving sputum characteristics as compared to the other two groups. More patients in Salbutamol +Guaphenesin+bromhexine reported excellent efficacy (44.4%) as compared to only 14.6% in Salbutamol +Guaphenesin and 13% in Salbutamol +Bromhexine. In conclusion, cough expectorant containing salbutamol + bromhexine +guaiphenesin could be the expectorant of choice in alleviating productive cough since it scored in terms of efficacy as well as tolerability over salbutamol with either bromhexine or guiaphenesin alone.  
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