| CTRI Number |
CTRI/2020/10/028365 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
09/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study for the comparison of usefulness and quality of life of patients with airway disease after taking corticosteroid and bronchodilator drug combination |
|
Scientific Title of Study
|
A study to evaluate the real world effectiveness of Inhaled corticosteroid/Long acting beta agonist combination and assessment of Health related quality of life among COPD patients on this therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
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, Patiala |
| Address |
Department of Pharmacology,
Government Medical College and Rajindra Hospital
Patiala
PUNJAB
147001
India |
| Phone |
7696194100 |
| Fax |
|
| Email |
dramrit24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay K Sehgal |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College and Rajindra Hospital, Patiala |
| Address |
Department of Pharmacology,
Government Medical College and Rajindra Hospital
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, Patiala |
| Address |
Department of Pharmacology,
Government Medical College and Rajindra Hospital
Patiala
PUNJAB
147001
India |
| Phone |
7696194100 |
| Fax |
|
| Email |
dramrit24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Rajindra Hospital
Patiala
Punjab |
|
|
Primary Sponsor
|
| Name |
Department of Pharmacology |
| Address |
Government Medical College and Rajindra Hospital,
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 |
OPD Room No. 8,
Department of Pulmonary Medicine,
Government TB Hospital (GMC, PATIALA)
Patiala
PUNJAB |
7696194100
dramrit24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt. Medical College, Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide Formoterol combination |
Budesonide Formoterol combination given in group I in dose of 200/6 or 400/6 microgram 2 puffs OD for a period of 4 weeks.
Route - Inhalational |
| Comparator Agent |
Fluticasone Salmeterol combination |
Fluticasone Salmeterol combination given in group II in dose of 250/50 microgram 2 puffs OD, for 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. Male and female patients of age 40 years or more.
2. Patient with at least 1 Inpatient Department visit with primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
3. Patient with at least 1 Emergency Department visit with COPD diagnosis.
4. Patient not having an exacerbation for one month prior to study entry.
5. Patient on inhalational therapy for 2-3 weeks. |
|
| ExclusionCriteria |
| Details |
1. Patient diagnosed with asthma or other non-COPD respiratory disorder.
2. Patient with history of any previous lung volume reduction surgery and/or lung transplantation.
3. Patient who requires 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. Immuno-compromised (HIV +ve) patients
8. Patients who are not willing to give written informed consent. |
|
|
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 |
| Comparison in exacerbation rate and SGRQ score in patients of COPD on Budesonide/Formoterol combination versus Fluticasone/Salmeterol combination. |
2 week and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To manage the side effects of both Budesonide/Formoterol combination and Fluticasone/Salmeterol combination in COPD patients. |
2 week and 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)
|
15/10/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, open-label, randomized parallel group comparative study to evaluate the real-world effectiveness of Inhaled Corticosteroid/Long Acting Beta Agonist combination and assess the Health-related Quality of life, in Chronic Obstructive Pulmonary Disease patients.
The study is to be conducted for a duration of one year from the date of approval of plan of thesis from Ethics Committee of BFUHS, Faridkot and Government Medical College, Patiala. It includes total of 80 patients, 40 patients in group I and 40 patients in group II. Patients coming to the Dept. of Pulmonary Medicine, Government TB Hospital, Patiala (GMC, Patiala) 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. Study samples will be balanced on age, gender, and pre-index characteristics including COPD-related inpatient hospitalizations and Emergency Department visits.
In group I, patients will receive inhaled Budesonide/Formoterol combination (BFC- 200/6 microgram or 400/6 microgram) 1-2 puff OD. In group II, patients will receive inhaled Fluticasone/Salmeterol combination (FSC - 250/50 microgram) 1-2 puff OD. The effectiveness of drugs will be evaluated by observing change in exacerbation rate. Adverse drug reactions will be monitored in patients. Health related quality of life will be evaluated by administering St. George’s Respiratory Questionnaire (SGRQ). Effectiveness of the drugs will be calculated in terms of improvement in breathlessness Modified Medical Research Council (mMRC) scale.
All the observations thus made will be statistically analyzed using appropriate tests. |