| CTRI Number |
CTRI/2020/08/027069 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Study to compare the efficacy and safety of Deflazacort tablets versus Prednisolone Tablets versus Methylprednisolone Tablets in patients with Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
A Prospective, Randomized, Open-label, Investigator-initiated Study to Evaluate the Short-term and Long-term Efficacy and Safety of Deflazacort Tablets, Prednisolone Tablets and Methylprednisolone Tablets in Patients with COPD |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-009-DEFL-2019 Ver 1.0 27 Nov 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshu Shashikant Pophale |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
Room No 1
Department of Respiratory Medicine
Lokmanya Medical Research Center
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Room No 1
Department of Respiratory Medicine
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Mumbai (Suburban)
MAHARASHTRA
411033
India |
| Phone |
7588693308 |
| Fax |
|
| Email |
himanshupophale@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Shashikant Pophale |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
Room No 1
Department of Respiratory Medicine
Lokmanya Medical Research Center
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Room No 1
Department of Respiratory Medicine
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Mumbai (Suburban)
MAHARASHTRA
411033
India |
| Phone |
7588693308 |
| Fax |
|
| Email |
himanshupophale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu Shashikant Pophale |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
Room No 1
Department of Respiratory Medicine
Lokmanya Medical Research Center
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Room No 1
Department of Respiratory Medicine
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune
Mumbai (Suburban)
MAHARASHTRA
411033
India |
| Phone |
7588693308 |
| Fax |
|
| Email |
himanshupophale@yahoo.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| MACLEODS PHARMACEUTICALS LTD.
R & D III, Plot No. 18, Street No. 9, MIDC Area
Andheri-(East), Mumbai 400 093, India. |
|
|
Primary Sponsor
|
| Name |
Lokmanya Medical Research Center |
| Address |
Lokmanya Hospital
314/B Telco Road
Chinchwad
Pune-411033
Maharashtra
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Himanshu Pophale |
Lokmanya Medical Research Center |
Room No 1
Department of Respiratory Medicine
Lokmanya Hospital,314/B, Telco Road,Chinchwad, Pune-411033,Maharashtra,India
Mumbai (Suburban)
MAHARASHTRA |
7588693308
himanshupophale@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Lokmanya Medical Research Center |
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 |
Deflazacort Tablets (Macleods Pharmaceuticals Ltd.)
|
Oral Deflazacort Tablets 0.5-1.0 mg/kg/day
Investigators are allowed to adjust study treatment regimen (dose per day, frequency per day, total
duration of treatment) as per their standard clinical practice during the entire treatment period
|
| Comparator Agent |
Methylprednisolone Tablets (Medrol-Pfizer Ltd.) |
Oral Methylprednisolone Tablets 0.65-1.35 mg/kg/day
Investigators are allowed to adjust study treatment regimen (dose per day, frequency per day, total duration of treatment) as per their standard clinical practice during the entire treatment period |
| Comparator Agent |
Prednisolone Tablets (Wysolone®-Pfizer Ltd.) |
Oral Prednisolone Tablets 0.65-1.0 mg/kg/day
Investigators are allowed to adjust study treatment regimen (dose per day, frequency per day, total
duration of treatment) as per their standard clinical practice during the entire treatment period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female with COPD aged between 18 to 65 years (both ages inclusive) requiring
oral corticosteroid treatment
2. Patient having FEV1 more than or equal to 45% of predicted normal value
3. Patients having FEV1/FVC ratio less than 0.70
4. Patients with CRP level more than 3 mg/L
5. Patients should be on stable COPD treatment regimen for at least 4 weeks prior to screening
6. Patients who have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past
year and has less than or equal to 10 pack years of historical use
7. Ability to withhold stable COPD treatment and quick-relief treatment for at least 12 h before
spirometry, in the opinion of the Investigator
8. Women of childbearing potential must be willing to consistently use an appropriate method of
contraception
9. Patients willing to give their written informed consent to participate in the study
10. Patients willing to comply with all aspects of the protocol
11. Ability to follow training given for study related procedures and assessments in the opinion of
the Investigator |
|
| ExclusionCriteria |
| Details |
1. Patients who require continuous daily oxygen therapy
2. Concurrent use of medications (except quick-relief) having significant drug-interaction with
study treatment affecting COPD condition or which may affect safety of the patient or interfere
with study results in the opinion of the Investigator
3. Patients suffering from rheumatologic disorders
4. Significant chronic respiratory disease other than COPD which may affect the safety of the
patient or interfere with study results in the opinion of the Investigator
5. History of behavioral and mood disturbances which may include euphoria, insomnia, mood
swings, personality changes, severe depression, and psychosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as assessed by FEV1, FVC and FEV1/FVC% measured after short term treatment from baseline |
8 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as assessed by change in C-reactive protein (CRP) levels after short term treatment from baseline |
3 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/08/2020 |
| 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="0"
Months="3"
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
|
Chronic
Obstructive Pulmonary Disease (COPD) is a common, lung disorder characterized
by progressive, poorly reversible airflow limitation often with systemic
manifestations, in response to tobacco smoke and/or other harmful inhalational
exposures.†COPD affects more than 400 million people worldwide. According to
the 12-site Burden of Obstructive Lung Disease study, the average prevalence of
COPD is 10.1%, with wide variations. The estimated burden of COPD in India is
about 15 million cases (males and females contributing to 9.02 and 5.75
million, respectively). These figures may however underestimate the true burden
since questionnaire based prevalence rates tend to underestimate the true
spirometry-based prevalence of COPD. Globally, COPD is the ninth leading cause
of loss of disability adjusted life years (DALYs) according to the baseline
projections made in the Global Burden of Disease Study. In India, chronic
respiratory diseases account for 3% of DALYs, and COPD is the major cause among
chronic respiratory disease. COPD also accounts for more than 3 million deaths
per year globally making it the third leading cause of death worldwide. In
India, COPD causes about 500,000 deaths per year.
Rational of Study Amongst
the available corticosteroids, prednisolone and methylprednisolone are used
widely for managing inflammation in COPD patients. Oral administration of these
drugs has resulted in improvement in lung functions and significant reduction
of inflammatory cytokines. Deflazacort which was introduced in late 60s is also
being considered now because of its better safety profile with equivalent
potency. In contrast to Prednisolone and Methylprednisolone, Deflazacort do not
deteriorate the glycemic and lipid profile in the patients. In a study,
Deflazacort treatment also prevented the excessive bone loss and fat
accumulation compared to prednisolone and methyl prednisolone therapy in kidney
transplant patients. The short term efficacy (1-2 weeks) and safety of
prednisolone, methylprednisolone and Deflazacort in COPD patients is very well
established through several clinical trials but there is not enough data for these
drugs in long term efficacy and safety (6-8 weeks). These drugs have been used
safely for long term in other inflammatory conditions like rheumatoid arthritis
and inflammatory bowel disease. Additionally, a study which evaluated effect of
long term use of glucocorticoids reported that COPD were amongst major disease
conditions for which oral glucocorticoids were used for long term. With this
background, this study is proposed to evaluate the short and long term
beneficial effects of Prednisolone, Methylprednisolone and Deflazacort in
patients with COPD
STUDY OBJECTIVES
Primary Efficacy Objectives
To evaluate the efficacy of
Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as
assessed by FEV1, FVC and FEV1/FVC% measured after short term treatment from baseline
To evaluate the efficacy of Deflazacort,
Prednisolone and Methylprednisolone in patients with COPD as assessed by FEV1,
FVC and FEV1/FVC% measured after long term treatment from baseline
Secondary Efficacy Objectives
To evaluate efficacy of
Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as
assessed by change in C-reactive protein (CRP) levels after short term
treatment from baseline
To evaluate efficacy of
Deflazacort, Prednisolone and Methylprednisolone in patients with COPD as
assessed by change in CRP levels after long term treatment from baseline
Safety Objectives
To evaluate the changes in random
blood sugar in all the treatment groups after short term and long term
treatment from baseline
To evaluate the changes in lipid
profile in all the treatment groups after short term and long term treatment
from baseline
To compare the changes in
12-lead-ECG, hematology and biochemistry tests after short term and long term
treatment from baseline
To assess safety and tolerability
of the IP as assessed by treatment emergent adverse events (TEAEs) during short
and long term treatment
STUDY DESIGN Overview of the Study Design This is a prospective, randomized, open-label, investigator-initiated study to evaluate the short-term and long-term efficacy and safety of Deflazacort tablets, Prednisolone tablets and Methylprednisolone tablets in Patients with COPD. Following will be the study site visits during study period: • Visit 1/Screening period: Up to 4 days • Visit 2/Randomization • Visit 3/Interim visit during study treatment period (Day 8 (±4 days) after first dose of study treatment) • Visit 4/Interim visit during study treatment period (Day 16 (±4 days) after first dose of study treatment) • Visit 5 (Day 21 (±4 days)/End-of-treatment (EOT) study site visit and assessments • Safety follow-up/End-of-study (EOS)/Visit 6 (Telephonic): Investigator or designee will contact patient telephonically after 10 days (±2 days) from end-of-treatment (EOT) day to collect any adverse event related information. This will mark the End-of-study (EOS) visit. Additionally, during the treatment period, patients will be contacted telephonically as per Investigator’s discretion to ascertain compliance to study medication and to collect safety information, if any.
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