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CTRI Number  CTRI/2018/09/015862 [Registered on: 28/09/2018] Trial Registered Prospectively
Last Modified On: 20/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate efficacy and safety of Respiforb in patients with partly controlled asthma  
Scientific Title of Study   An open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb® inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthma’  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KI/1117-1 Version 1.0, Date: April 06, 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand Chaudhari 
Designation  Principal Investigator 
Affiliation  Rajpal Hospital 
Address  Rajpal Hospital, Department of Medicine, First Floor, Room number 01, Sector 10, Koparkhairane, Navi Mumbai.

Thane
MAHARASHTRA
400709
India 
Phone  9870351025  
Fax    
Email  dranandchaudhari100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshad Dabhade 
Designation  Head Clinical Operations 
Affiliation  Mudra Clincare 
Address  Department of Clinical Research, Ground Floor, Room number 01, Plot No 80, Sector 8, Koparkhairane Navi Mumbai, 400709, Maharashtra INDIA.

Thane
MAHARASHTRA
400709
India 
Phone  8850102096  
Fax    
Email  dr.harshad.d@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Waghmare 
Designation  QAQC 
Affiliation  Mudra Clincare 
Address  Department of Clinical Research, Ground Floor, Room Number 01, Plot 135, Sector 06, Koparkhairane, Navi Mumbai.

Thane
MAHARASHTRA
400709
India 
Phone  08850102096  
Fax    
Email  drmwaghmare524@gmail.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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Varade  AIMS Hospital  Department of Medicine, Room Clinical Research, Ground Floor, P-72, Milap Nagar, Dombivli,India 421203
Thane
MAHARASHTRA 		 9870409142

deepak.varade@gmail.com 
Dr Anand Chaudhari  Rajpal Hospital  Department of Medicine, Room number 01, First Floor, Sector 10, near D-mart Koparkhairane
Thane
MAHARASHTRA 		 8850102096

dranandchaudhari100@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ashirwad Institutional Ethics Committee  Approved 
Suraksha Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, (2) ICD-10 Condition: L00||Staphylococcal scalded skin syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Respiforb   Inhalation powder, pre-dispensed Dose regimen- One inhalation (320+9 μg/dose) twice daily Route of administration is oral Frequency twice daily for 80 days 
Comparator Agent  Symbicort Turbuhaler  Inhalation powder, pre-dispensed Dosing regimen- One inhalation (320+9 μg/dose) twice daily Route of administration is oral, Frequency twice daily for 80 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Availability of a signed copy of the Informed Consent Form of the Patient Information Leaflet.
2. Male and female patients 18 to 70 years of age (inclusive) at the moment of signing the Informed Consent Forms (ICF).
3. Diagnosis of persistent asthma established according to the GINA guidelines (2017) not less than 6 months prior to the screening visit.
4. Asthma that is inadequately controlled by inhaled corticosteroids (ICS) inhaled corticosteroids and short-acting beta-agonists (SABA) as on-demand therapy.
5. Need to use bronchodilatory therapy with a combination of ICS and long-acting beta agonists (LABA).
6. ACQ-5 score ≥0.75 and <1.5 
 
ExclusionCriteria 
Details  1. Patients who need the selection of initial maintenance therapy for asthma.
2. Contraindications for use of ICS, hypersensitivity to budesonide, formoterol, salbutamol, inhaled lactose or to any other component of the study drugs.
3. Lactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
4. A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2017 version of the GOLD guidelines.
5. Excessive requirement of SABA
6. Use of oral or parenteral corticosteroids within 2 months prior to the screening visit (3 months for extended-release parenteral ICS).
7. The use of immunosuppressive agents (e.g., cyclosporine, methotrexate, tumor necrosis factor (TNF) inhibitors or anti-TNF-antibodies, gold salts, azathioprine) within 4 weeks prior to the screening visit.
8. Conditions that require the use of systemic therapy with corticosteroids at the time of the screening visit.
9. Unexpected progressive deterioration of asthma symptom control.
10. A history of a nearly fatal asthma attack (e.g., unstable asthma, hospitalization due to asthma exacerbation to ICU with the use of intubation).
11. Pulmonary tuberculosis (active or inactive form).
12. Fungal, viral, or bacterial respiratory tract infections, or systemic viral infection, Herpes simplex-related eye disease at the moment of the screening visit.
13. Lower respiratory tract infection within 1 month prior to the screening visit.
14. Cystic fibrosis, bronchiectasis, pneumoconiosis.
15. Restrictive ventilatory defects.
16. Uncontrolled hypokalemia, hypocalcaemia.
17. Thyrotoxicosis.
18. Osteoporosis.
19. Glaucoma, cataract. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in FEV1   At Visits 1 and 4 
 
Secondary Outcome  
Outcome  TimePoints 
FEV1 changes  assessed 2 hours after inhalation of the test drug/reference drug. 
PEF changes   by Visits 2, 3, and 4. 
ACQ-5 score   changes over time. 
SF-36 (quality of life questionnaire) score   changes over time. 
Percentage of patients achieving asthma control   by Visit 4. 
Weekly average daily SABA requirement (salbutamol)   at Week 1, 4, 8, and 12. 
Percentage of patients who developed exacerbation   by Visits 2, 3, and 4. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="120" 
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)   02/10/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/10/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="12" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Suspended 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
The planned study is an open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb®, inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthma.
Total duration of the study for each patient will not exceed 102 days
The 1st group of patients will receive Respiforb® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).
The 2nd group of patients will receive Symbicort® Turbuhaler® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).

 
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