| CTRI Number |
CTRI/2018/06/014573 [Registered on: 19/06/2018] Trial Registered Prospectively |
| Last Modified On: |
23/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
comparison of various respiratory medicines in patients with chronic airway disease of prolong duration |
|
Scientific Title of Study
|
A comparative evaluation of safety and efficacy of formoterol with tiotropium bromide and formoterol with glycopyrronium in patients of COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siraj Ahmad |
| Designation |
Junior Resident |
| Affiliation |
Jawahar lal nehru medical college and hospital |
| Address |
Department of Phamrmacology, JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9582626153 |
| Fax |
|
| Email |
sirajahmad9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Farida Ahmad |
| Designation |
Professor |
| Affiliation |
Jawahar lal nehru medical college and hospital |
| Address |
Department of Phamrmacology, JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417735300 |
| Fax |
|
| Email |
fahmad32@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siraj Ahmad |
| Designation |
Junior Resident |
| Affiliation |
Jawahar lal nehru medical college and hospital |
| Address |
Department of Phamrmacology, JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9582626153 |
| Fax |
|
| Email |
sirajahmad9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Phamacology, JNMCH, AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of pharmacology |
| Address |
Jawahar lal nehru medical college, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siraj Ahmad |
PG Lab Department of Pharmacology and OPD Department of Tuberculosis and Respiratory disease |
JNMCH, AMU, Aligarh
Aligarh
UTTAR PRADESH |
9582626153
sirajahmad9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
chronic obstructive pulmonary disease , (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with grade II and III COPD in age group of 18 - 65 of both genders will be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Complicated cases of COPD patients
Patients with clinically significant lung disease other than COPD
Patients with respiratory failure
Patients who are on systemic corticosteroid therapy
Pregnant and Lactating patients.
Psychotic patients.
Critically ill patients.
Patients with comorbid conditions like myocardial infarction, diabetes mellitus 5
Known cases of HIV/HBsAg /Anti-HCV and immuno-compromised patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety and cost effectiveness |
3 month |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2018 |
| Date of Study Completion (India) |
20/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
Modification(s)
|
Chronic obstructive pulmonary disease (COPD) is a leading cause of death especially in developing countries like India. To improve the health condition among the COPD patients a better yet cost effective treatment combination is required. This study is focussed on finding out an effective treatment combination for such patients. |