| CTRI Number |
CTRI/2019/10/021728 [Registered on: 21/10/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study for the uses and side effects of corticosteroids and bronchodilator drugs in people with airway problems |
|
Scientific Title of Study
|
A study to evaluate the efficacy and safety profile of inhaled corticosteroid/long acting beta agonist combination among COPD patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMRIT PAL KAUR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND RAJINDRA HOSPITAL |
| Address |
Department of Pharmacology,
Government Medical College,
Patiala.
Patiala
PUNJAB
147001
India |
| Phone |
7696194100 |
| Fax |
|
| Email |
dramrit24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY K SEHGAL |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND RAJINDRA HOSPITAL |
| Address |
Department of Pharmacology,
Government Medical College,
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9872197861 |
| Fax |
|
| Email |
vijayksehgal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMRIT PAL KAUR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND RAJINDRA HOSPITAL |
| Address |
Department of Pharmacology,
Government Medical College,
Patiala
Patiala
PUNJAB
147001
India |
| Phone |
7696194100 |
| Fax |
|
| Email |
dramrit24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Patiala,
Punjab. |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHARMACOLOGY |
| Address |
Department of Pharmacology,
Government Medical College,
Patiala,
Punjab. |
| 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 AMRIT PAL KAUR |
Government TB Hospital Attached to Government Medical College, Patiala. |
OPD Room No. 8, Department of Pulmonary Medicine.
Patiala
PUNJAB |
7696194100
dramrit24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide Formoterol Combination |
Budesonide Formoterol Combination (BFC) in group I in dose of 200/6 or 400/6 microgm 2 puffs OD over a period of 4 weeks.
Route - Inhalational |
| Comparator Agent |
Fluticasone Salmeterol Combination |
Fluticasone Salmeterol Combination (FSC) in group II in dose of 250/50 microgm 2 puffs OD over a period of 4 weeks.
Route - Inhalational |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age more than 40 years.
2. At least 1 inpatient visit with a primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
3. At least 1 ED visit with a COPD diagnosis (either primary or secondary).
4. Patient not having an exacerbation for one month prior to study entry.
5. Patient on inhalational therapy – 2-3 weeks. |
|
| ExclusionCriteria |
| Details |
1. Patient diagnosed with asthma or other non-COPD respiratory disorder.
2. Any previous lung volume reduction surgery AND/OR lung transplantation.
3.A requirement for oxygen therapy for at least 12 hours per day.
4. Any exclusionary co-morbid medical condition (cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, or any other condition likely to cause death within 3 years.
5. Current use of oral/injectable corticosteroid therapy.
6. Patients (diagnosed with cancer) who received ≥ 180 days of oral corticosteroids (OCS) in the 12-month pre-index period.
7. Patients who initiated both study medications on the same date.
8. Immuno-compromised (HIV +ve) patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination. |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the side effects of both Budesonide/formoterol combination and Fluticasone/salmeterol combination. |
4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/10/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, open randomized parallel group comparative study to evaluate the efficacy and safety profile of Budesonide Formoterol Combination versus Fluticasone Salmeterol Combination in Chronic Obstructive Pulmonary Disease patients. The study will be conducted for a duration of one and half year from date of approval from Ethics Committe of Govt. Medical College, Patiala. The study includes 80 patients, 40 patients in each group (group I and group II) coming to Department of Pulmonary Medicine, Government Tb Hospital attached to Government Medical College, Patiala. Patients from each group (BFC and FSC), diagnosed by GOLD criteria, fulfilling the inclusion criteria and having none of exclusion criteria, will be enrolled in the study after obtaining the written informed consent. In group I, patients will receive Budesonide Formoterol combination (BFC) 200/6 or 400/6 microgm 2 puffs OD. In group II, patients will receive Fluticasone Salmeterol combination (FSC ) 250/50 microgm 2 puffs OD. The therapeutic efficacy of drugs will be evaluated by spirometric indices (FEV1,FVC and FEV1/FVC). Adverse drug reactions will be monitored in patients. Effectiveness of the drugs will be evaluated by change in spirometric indices (FEV1,FVC and FEV1/FVC). All the observations thus made, will be statistically analyzed using appropriate tests. |