| 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
|
|
|
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
|
|
|
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. |