| CTRI Number |
CTRI/2020/09/027824 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
efficacy and safety of Ciclesonide, metered-dose inhaler |
|
Scientific Title of Study
|
International, open-label randomized comparative study of the efficacy and safety of Ciclesonide metered-dose inhaler, 160 μg/dose (LLC “PSK Pharmaâ€, Russia) and Alvesco, metered-dose inhaler, 160 μg/dose (AstraZeneca AB, Sweden) in patients with partially controlled asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CYK-4/19, Version: 1.0 date: December 2, 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uma Mulay |
| Designation |
Principal Investigator |
| Affiliation |
Orchid Hospital |
| Address |
Department of Medicine, 1st Floor, B Wing, Sector 18, Kamothe, India
Mumbai (Suburban)
MAHARASHTRA
410209
India |
| Phone |
7738664583 |
| Fax |
|
| Email |
drumamulay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
Head Medical Affairs |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
Mumbai (Suburban)
MAHARASHTRA
400709
India |
| Phone |
|
| Fax |
|
| Email |
md@mudraclincare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sadgune |
| Designation |
Head Medical Affairs |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
MAHARASHTRA
400709
India |
| Phone |
|
| Fax |
|
| Email |
md@mudraclincare.com |
|
|
Source of Monetary or Material Support
|
| Mudra Clincare, Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709,
Maharashtra, INDIA. |
|
|
Primary Sponsor
|
| Name |
PSK Pharma LLC |
| Address |
2 Programmistov 4, premise 215, Dubna town, Moscow Region
141983 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA. |
|
|
Countries of Recruitment
|
India
Russian Federation |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Mulay |
Orchid Hospital |
Department of Medicine, Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe, India
Mumbai (Suburban)
MAHARASHTRA |
7738664583
drumamulay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashirwad Institutional Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ciclesonide
Metered-dose inhaler |
1 inhalation of 160 mcg/dose BID |
| Comparator Agent |
Ciclesonide, Alvesco (Metered-dose inhaler) |
1 inhalation of 160 mcg/dose BID |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ACQ-5 asthma control test result: ≥ 0.75 and <1.5
Forced expiratory volume - 1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit).
Positive result of the test for reversibility of airway obstruction, expressed as ΔFEV1 ≥12% and ≥200 ml vs. baseline 30 minutes after the use of 400 µg of Salbutamol.
Signed Informed consent form for participation in the clinical study in the Patients Information Sheet |
|
| ExclusionCriteria |
| Details |
Patients with the need for selection of initial maintenance therapy of BA.
Contraindications to the use of iGCS, hypersensitivity to Ciclesonide, Salbutamol or any components of the study product
Use of glucocorticosteroids, either oral or for parenteral administration, less than 2 months before the screening visit (3 months for parenteral long-acting GCS).
Use of immunosuppressors less than 4 weeks before the screening visit (e.g. cyclosporine, methotrexate, anti-tumor necrosis factor α-receptors (TNF), gold preparations, azathioprine etc.).
Conditions requiring the use of systemic GCS at the time of the screening visit.
Unexpected and progressive deterioration of control of symptoms of BA.
Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma
Pulmonary tuberculosis (active or inactive form).
Fungal, viral or bacterial respiratory infections or systemic viral infections, herpetic ocular lesions (Herpes simplex) at the time of the screening visit.
Infection of the lower respiratory tract less than 1 month before the screening visit.
1Cystic fibrosis, bronchiectasis, pneumoconiosis.
Restrictive type breathing disorders.
Uncontrolled hypokalemia, hypocalcemia.
Thyrotoxicosis.
Decompensated diabetes mellitus.
Osteoporosis.
Glaucoma, cataract.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the PEF1 value |
Visits 1 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in FEV1 value
|
2 hours after the inhalation of the study/reference product. |
| Evolution of the PEF value |
as measured at Visits 2, 3 and 4. |
Changes of the index according to the ACQ-5 questionnaire for evaluation of BA control
|
from baseline. |
| Changes in quality of life indicators (QOL) according to the SF-36 questionnaire |
from baseline |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="112"
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)
|
18/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/09/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="26" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bronchial asthma is a heterogeneous disease, characterized by chronic inflammation of the
respiratory tract, and accompanied by respiratory symptoms such as wheezing,
dyspnea, chest congestion and cough. These signs vary in duration and intensity
and manifest along with variable airway obstruction - To
assess the efficacy of treatment with Ciclesonide, metered-dose inhaler in patients with partially controlled BA.
- To
assess the safety of treatment with Ciclesonide, metered-dose inhaler in patients with partially controlled BA.
- To assess the effect of
Ciclesonide, metered-dose inhaler on the quality of life of patients with
partially controlled BA metered-dose inhaler |