| CTRI Number |
CTRI/2009/091/000112 [Registered on: 25/03/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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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
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| GP/01/08 |
Other |
| GP/01/08 |
Other |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. Akhilesh Sharma |
| Designation |
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| Affiliation |
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| 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 |
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Details of Contact Person
Scientific Query
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| 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 |
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Details of Contact Person
Public Query
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| 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 |
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Source of Monetary or Material Support
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| Glenmark Pharmaceuticals Ltd. Mumbai |
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Primary Sponsor
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| Name |
Glenmark Pharmaceuticals Ltd
BD Sawant Marg, Chakala,
Off. Western Express Highway,
Andheri (E), Mumbai 400 099
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| Address |
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| Type of Sponsor |
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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 = 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 |
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Details of Ethics Committee
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| East Coast Hospital |
Approved |
| Path Independant Ethics Committee |
Approved |
| Sooriya 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 associated with Acute Bronchitis, AECB, Pneumonia and Asthmatic Bronchitis
, |
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Intervention / Comparator Agent
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| 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 |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| 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.
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| 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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare the change in consistency of sputum between the test and reference drugs |
End of study |
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Secondary Outcome
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| 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 |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
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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 |
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Estimated Duration of Trial
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Years="0"
Months="5"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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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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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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