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CTRI Number  CTRI/2019/04/018694 [Registered on: 23/04/2019] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A clinical study to evaluate the effectiveness and safety of a cough clearing formulation in comparison with ambroxol for clearing cough in bronchial asthma. 
Scientific Title of Study   A cross-section, observational, drug utilization study to assess productive cough symptom control in Br. asthma and phenotypes (ASTHMA*Cough study)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Salil Bendre 
Designation  Chest Consultant and Interventional Bronchoscopist 
Affiliation  The Chest Clinic and Sleep Lab, KLS Hospital 
Address  Room no. 6, Department of Chest Medicine, 2nd Floor, Opp Irla Petrol Pump, Off SV Road, Irla, Vile Parle West, Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  02226714448   
Fax    
Email  salilsaumil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Krishnaprasad 
Designation  General Manager- Medical Services 
Affiliation  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark Corporate Enclave, B D Sawant Marg, Chakala, Andheri (East), Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9820806811   
Fax    
Email  K.Krishna.Prasad@glenmarkpharma.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Krishnaprasad 
Designation  General Manager- Medical Services 
Affiliation  Glenmark Pharmaceuticals Ltd. 
Address  Glenmark Corporate Enclave, B D Sawant Marg, Chakala, Andheri (East), Mumbai.

Mumbai (Suburban)
MAHARASHTRA
400099
India 
Phone  9820806811   
Fax    
Email  K.Krishna.Prasad@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark House, B D Sawant Marg, Chakala, Andheri (East), mumbai- 400099 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kumar Doshi  NuLife Hospital  A1, Harekrishna Building, 1st Floor, Near Telephone Exchange, LBS Rd, Jivdaya Lane, Ghatkopar West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA 
9821029139

kumardoshi2000@yahoo.com 
Dr Salil Bendre  The Chest Clinic and Sleep Lab, KLS Hospital  Room no. 6, Department of Chest Medicine, 2nd Floor, Opp Irla Petrol Pump, Off SV Road, Irla, Vile Parle West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA 
02226714448

salilsaumil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Suraksha-Ethics Committee  Approved 
Suraksha-Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ambroxol  Route of administration: Oral with treatment duration of 7 days 
Intervention  Terbutaline, Bromhexine, Guaiphenesin, Menthol   Route of administration: Oral with treatment duration of 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults with bronchospastic respiratory conditions or bronchial asthma requiring outpatient therapy with bronchodilatory or mucolytic cough formulations. 
 
ExclusionCriteria 
Details  Patients with < 1 follow up visit to be excluded from this concurrent analyses

Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of ≥6 dosages in a day for the last week

Patients who have been hospitalized and received antimicrobial therapy within the last 24 hours

Patients at high risk for infection with 6Ps; pneumonia, pulmonary embolism, pneumothorax, pleural effusion, pulmonary oedema [heart failure] and paroxysmal atrial tachycardia(arrhythmias)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cough Severity at day 7

Sputum consistency at day 7

Nocturnal awakening frequency (No. of Episodes/night) at day 7 
Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment emergent adverse event rate with Bronchodilator based Cough Formulation and ambroxol  Day 7 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   23/04/2019 
Date of Study Completion (India) 02/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Cough is a protective reflex which help to remove any foreign material and excessive mucous produced during the inflammation of the respiratory lining. However, cough impairs the quality of life in terms of disturbances in sleep, daily activities and social stigmata. Cough reflex is complex, which involves central and peripheral nervous system as well as the smooth muscles of the bronchial tree. This results in bronchoconstriction, which in turn increase the sensitivity of the cough receptors. The supplementary role of Bronchodilatory Cough formulation in offering effective control of associated symptoms has been well highlighted. These bronchodilators have been suggested to offer ancillary actions that go beyond bronchodilation including differential impact on cough sensitivity, clearance of cough secretions while reducing protrusive inflammatory mediators’ release that is so common in these inflammatory conditions. At the same time these hyper mucosecretory states are better controlled by a combination of mucolytics/expectorants with bronchodilators. The complimentary action of the mucolytics with bronchodilator including Terbutaline improves sputum viscosity and mucociliary clearance or expulsion for better control of productive cough symptoms.

Data regarding use of oral bronchodilator based cough formulations (BCF) and/or xanthines in management of Bronchial asthma symptoms including cough remains unexplored.

To further assess the real world utilization of treatment strategies for Cough clearance in Bronchial asthma cases an observational, drug utilization, case control, concurrent analyses is planned.

 
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