| CTRI Number |
CTRI/2017/02/007787 [Registered on: 06/02/2017] Trial Registered Prospectively |
| Last Modified On: |
06/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of the Efficacy and Safety of Budesonide, Inhalation Powder, Capsule 400 μg/dose |
|
Scientific Title of Study
|
Open-label, Multicentre, Randomized, Comparative Study of the efficacy and Safety of Budesonide, Inhalation powder, Capsule 400 μg/dose (Sava Healthcare Limited, India), and Pulmicort® Turbuhaler®, Inhalation powder, pre-dispensed, 200 μg/dose (AstraZeneca AB, Sweden), in Patients with Partially Controlled Asthma.†|
| Trial Acronym |
DPI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ÐœÐ/1215-5 Version No.: 1.0, Dated: 20/06/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhatt |
| Designation |
General Director |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
09167243914 |
| Email |
hbo@nexuscro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mangesh Khadakban |
| Designation |
Head CRO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
09167243914 |
| Fax |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mangesh Khadakban |
| Designation |
Head CRO |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
09167243914 |
| Fax |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
|
Source of Monetary or Material Support
|
| Rus Biopharm LLC
664009, Russia, Irkutsk, Ul. Shiryamova, 36, Office 204
Tel./Fax: 8 (3952) 500-456 |
|
|
Primary Sponsor
|
| Name |
Rus Biopharm LLC |
| Address |
664009, Russia, Irkutsk, Ul. Shiryamova, 36, Office 204
Tel./Fax: 8 (3952) 500-456 Е-mail: md@rusbiopharm.ru |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nexus Clinical Research India Ltd |
32 A, Nexus Centre For Clinical Excellence,
Shiravane Road ,Service Industry, Sector -1,
Mumbai-Pune Highway, Nerul (E),
Navi Mumbai 400706, 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 Sarat Kumar Behera |
Hi Tech Medical College & Hospital |
Department of Medicine Second floor Room No. 02 Division Pulmonary, Pandara Rasulgarh Bhubaneshwar Odisha 751025 Cuttack ORISSA Cuttack ORISSA Cuttack ORISSA
Cuttack
ORISSA |
9439129178
behera.saiprasanna82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hi Tech Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
In patients with partially controlled asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide, inhalation powder, capsule 400 μg/dose. |
Manufactured by Sava Healthcare Limited, India.
1 inhalation (400 μg/dose) twice daily for 84 days |
| Comparator Agent |
Pulmicort® Turbuhaler®, inhalation powder, pre-dispensed, 200 μg/dose. |
Manufactured by AstraZeneca AB, Sweden.
2 inhalations (200 μg/dose) twice daily for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit
Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy
ACQ-5 score ≥ 0.75 and < 1.5.
Forced expiratory volume in 1 second (FEV1) prior to administration of bronchodilators not less than 60 % of the due value.
Availability of a signed and dated Informed Consent Form for participation in the study. |
|
| ExclusionCriteria |
| Details |
Contraindications for treatment with inhaled IC, hypersensitivity to budesonide, salbutamol, or to any other ingredient included in the formulation of salbutamol.
Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
Body mass index (BMI) > 35 kg/m2.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Magnitude of the increase in FEV1 |
at Visits 1, 2, and 4 before the inhalation and the use of SABAs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FEV1 changes |
Visit 2, 3, 4 |
| Changes in absolute PEF |
Visit 2, 3, 4 |
| Total ACQ-5 (asthma control questionnaire) score changes |
Visit 2, 3, 4 |
| SF-36 (quality of life questionnaire) score changes |
Visit 2 and Visit 4 |
| Proportion of patients achieving asthma control |
Visit 4 |
| Weekly average daily SABA requirement |
Visit 2, 3, 4 |
| Proportion of patients with exacerbated disease |
Visits 2, 3, and 4 |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="116"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/02/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="19" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as an open-label, multicentre, randomized, comparative trial. The total duration of the study for each patient will not exceed 109 days, of which the duration of screening will not exceed 14 days, the duration of the treatment period 84 days, and the duration of the follow-up period 11 days. Before the screening, the patient will be informed about this clinical study and the rules of participation in the study. If a patient consents to participate in this study, he / she will sign the Informed Consent Form in the Patient Information Leaflet. The Investigator will ask every patient to provide information on his / her mobile and home (if applicable) telephone numbers, as well as the telephone number of a contact person who can be contacted in case of impossibility of communication with the patient. After the signing of the Informed Consent Form in the Patient Information Leaflet, the patient will be enrolled in the study. The Investigator will assign a three-digit screening number to the patient. At each study site, patients will receive their screening numbers as they are enrolled in the study. The screening number will be recorded in the Study Screening Log and on the title page of the Case Report Form (CRF). After the screening procedures (see Section 6.8), patients who meet all inclusion criteria and do not meet any exclusion criteria will continue their participation in this study. |