| CTRI Number |
CTRI/2024/08/071763 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Oral doxophylline along with Inhaler therapy and only inhaler therapy in Chronic obstructive pulmonary disease patients. |
|
Scientific Title of Study
|
Comparative study of Oral Doxophylline along with Triple drug therapy versus Triple Drug Therapy in Stable Severe Chronic Obstructive Pulmonary Disease Patients A Randomised control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhagiradhi Thimmapuram |
| Designation |
Post graduate |
| Affiliation |
SRM medical college hospital and research institute |
| Address |
Department of respiratory medicine ,SRM medical college hospital ,Potheri Kattankulathur ,Kancheepuram ,TAMILNADU India
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7013845559 |
| Fax |
|
| Email |
bhagiradhithimmapuram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subramanian S |
| Designation |
Professor |
| Affiliation |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Department of respiratory medicine ,SRM medical college hospital ,Potheri Kattankulathur ,Kancheepuram ,TAMILNADU India
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9488507784 |
| Fax |
|
| Email |
subramas1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhagiradhi Thimmapuram |
| Designation |
Post graduate |
| Affiliation |
SRM medical college hospital and research institute |
| Address |
Department of respiratory medicine ,SRM medical college hospital ,Potheri Kattankulathur ,Kancheepuram ,TAMILNADU India
603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7013845559 |
| Fax |
|
| Email |
bhagiradhithimmapuram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Respiratory medicine ,Potheri ,Kattankulathur,603203,Kancheepuram |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital |
| Address |
Department of respiratory medicine ,potheri,kattankulathur,603203,KANCHEEPURAM,Tamil nadu,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhagiradhi Thimmapuram |
SRM medical college hospital and research centre |
Department of respiratory medicine,SRM Medical college Hospital Potheri Kattankulatur
Kancheepuram TAMILNADU
Kancheepuram
TAMIL NADU |
7013845559
bhagiradhithimmapuram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tablet Doxophylline |
Dosage-650 mg Sustained release
Per oral
Once daily
For 3 months |
| Comparator Agent |
Triple drug inhaler therapy
Formeterol fumarate,
Budesonide,
Glycopyronium . We
|
Formeterol fumarate -4.8 mcg
Budesonide-160mcg
Glycopyronium-9 mcg
Inhalation route
Twice daily
For 3 months
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
At least 6 months of diagnosis of chronic obstructive pulmonary disease, according to GOLD guidelines.(Baseline post bronchodilator forced expiratory volume is less than 50% of predicted value.)
|
|
| ExclusionCriteria |
| Details |
.Patient with bronchial asthma, tuberculosis, lung tumour, bronchiectasis, pneumonia or other diseases that might affect pulmonary function or ventilation.
2. Patients with acute exacerbation of COPD.
3.Patients with congestive heart failure, unstable arrhythmias, chronic hypotension, active peptic ulcer disease, recent myocardial infarction and severe liver/kidney disease.
4.Patients who are unable to take Dry powder/Metered dose inhaler effectively even after adequate training. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in symptoms using Chronic obstructive pulmonary disease assessment test scoring scale.
2.Spirometry
3.Six minute walk test
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of exacerbations |
3 months |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Detailed informed consent will be obtained from from the eligible patients.Then the patients will be alloted to Group A or Group B by computer generated random number sequencing.Allocation concealment will be done by sequentially numbered ,opaque ,sealed envelopes.Group A patients will receive oral doxophylline sustained release 650 mg once along with triple drug therapy formoteral fumarate 4,8 mcg ,Glycopyrrolate 9 mcg and budesonide 160 mcg through metred dose inhaler or dry powder inhaler of equivalent dosage.Group B will receive only Formeterol fumarate 4.8 mcg ,Glycopyrrolate 9 mcg and budesonide 160 mcg through metered dose inhaler and dry powder inhaler of equivalent dosage.All participants will be followed up on 30 th ,60 th abd 90 th of the study.During every visit all participants will be assessed subjectively and objectively assessed .Adverse effects will be noted in each follow up. |