| CTRI Number |
CTRI/2017/03/008277 [Registered on: 31/03/2017] Trial Registered Prospectively |
| Last Modified On: |
29/03/2017 |
| 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 Formoterol |
|
Scientific Title of Study
|
Comparative study of the efficacy and safety of Formoterol, dry powder capsules for inhalation, 12 µg and Foradil, inhalation powder, capsules, 12 µg in patients with partially controlled bronchial asthma“ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ÐœÐ/1215-4; Version:1.0 Date:June 20, 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhatt |
| Designation |
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 |
Dr Mangesh khadakban |
| Designation |
Clinical Operations |
| 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 |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh khadakban |
| Designation |
Clinical Operations |
| 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 |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
|
Source of Monetary or Material Support
|
| Rus Biopharm LLC
664009, Russian Federation, Irkutsk,
Ul. Shiryamova, 36, Office 206
|
|
|
Primary Sponsor
|
| Name |
Rus Biopharm LLC |
| Address |
664009, Russian Federation, Irkutsk,
Ul. Shiryamova, 36, Office 206
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NEXUS CLINICAL RESEARCH INDIA LTD |
exus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai 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 |
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
Khordha
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 bronchial asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Trade name: Foradil
International nonproprietary name (INN): formoterol
Pharmaceutical form:
inhalation powder, capsules
|
Description: Transparent colourless capsules with printing “CG“ on the cap and “FXF†on the body or “CG“ on the body and “FXF†on the cap, written in black ink. Capsule size: No. 3. |
| Intervention |
Trade name: Formoterol fumarate
International nonproprietary name: Formoterol
Pharmaceutical form: dry powder capsules for inhalation
|
A white to off-white powder in oblong capsules, with a transparent, colourless body and a light green cap.
Pharmacotherapeutic group: selective beta-2-adrenoreceptor agonist
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients 18 to 70 years of age inclusive.
2. Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit.
3. Need for combination bronchodilator therapy with long-acting beta-agonists in combination with inhaled glucocorticoids (IGC).
4. Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting
beta-agonists (SABA) as on-demand therapy.
|
|
| ExclusionCriteria |
| Details |
1. Patients for whom starting maintenance therapy for asthma has to be selected.
2. Contraindications for treatment with inhaled glucocorticoids, hypersensitivity to formoterol, salbutamol, or to any other ingredient included in the formulation of the investigational medicinal product, reference product, or salbutamol.
3. Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
4. Body mass index (BMI) > 35 kg/m2.
5. A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2015 version of the GOLD guidelines.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in FEV1 |
By the 2nd hour post inhalation during Visits 1 and 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in FEV1 |
by the 2nd hour post inhalation during Visits 2, 3, and 4. |
| Changes in absolute PEF |
by Visits 2, 3, and 4. |
| Total ACQ-5 (asthma control questionnaire) score changes |
by Visits 2, 3, and 4. |
| SF-36 (quality of life questionnaire) score changes |
by Visits 2 and 4. |
| Proportion of patients achieving asthma control (total ACQ-5 score 0.75) |
by Visit 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)
|
17/04/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2017 |
| 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.
The study will include the following periods:
Study Visits
Visit 0 (screening, Day -14 ... -1);
Visit 1 (randomization, Day 1);
Visit 2 (interim visit, Day 14 ± 2);
Visit 3 (interim visit, Day 56 ± 2);
Visit 4 (completion of therapy, Day 86 ± 2);
Visit 5 (telephone call, Day 93 ± 2). |