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CTRI Number  CTRI/2019/10/021608 [Registered on: 11/10/2019] Trial Registered Prospectively
Last Modified On: 05/02/2020
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A comparative study of Albuterol drug in Asthma patients 
Scientific Title of Study   A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Single-Dose, Four-Period, Crossover, Multi-Center Bioequivalence Study to Compare the Bronchodilating Effect of Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) of Deva Holding A.S. with Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) in Adult Asthmatics 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CRL041920, Version: 1.0 Dated 29 May 2019   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dharmesh Domadia 
Designation  Associate Vice President - Global Clinical Operations 
Affiliation  Cliantha Research Limited  
Address  Cliantha Research Limited, Department of Clinical Trial, Room No. 01, Second Floor, Garden View Corporate House No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad – 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9879590828  
Fax  07966219549  
Email  ddomadia@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nil Desai 
Designation  Assistant Manager Medical Services 
Affiliation  Cliantha Research Limited  
Address  Cliantha Research Limited, Department of Clinical Trial, Room No. 01, First Floor, Garden View Corporate House No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad – 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9879732959  
Fax  07966219549  
Email  nhdesai@cliantha.com  
 
Details of Contact Person
Public Query  
Name  Mr Sumit Dodia 
Designation  Project Manager – Clinical Trials 
Affiliation  Cliantha Research Limited  
Address  Cliantha Research Limited, Department of Clinical Trial, Room No. 01, Second Floor, Garden View Corporate House No. 8, Opp. AUDA Garden, Bodakdev, Ahmedabad – 380054, India

Ahmadabad
GUJARAT
380054
India 
Phone  9825538366  
Fax  07966219549  
Email  sdodia@cliantha.com  
 
Source of Monetary or Material Support  
Deva Holding A.S.Turkey  
 
Primary Sponsor  
Name  Deva Holding AS 
Address  Basin Ekspres Cad.No:1 34303 Halkali-Küçükçekmece/Istanbul - Turkey  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand K Patel  GMERS Medical College & Hospital  Department of Respiratory Medicine, OLD TB Hospital Campus, Gotri Main Road, Gotri, Vadodara- 390021
Vadodara
GUJARAT 		 9879771079

dranandkpatel@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Department of Respiratory, central spine, Agarsenaspatal Marg, Sector-7, Vidyadhar Nagar, Jaipur-302039
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Vinit Niranjane  Orange City Hospital and Research Institute  Department of Pulmonology, 2nd Floor, Research Unit 19, Pandey Layout, Veer Sawarkar Square, Nagpur-440015
Nagpur
MAHARASHTRA 		 9881015523

vinit.niranjane@gmail.com 
Dr Akash Balki  Shree Hospital and Critical Care Centre  Department of Pulmonology, 2nd Floor, 799,Om Nagar,Opp. Tajshree Building, Sakkardara Square, Nagpur-440009
Nagpur
MAHARASHTRA 		 9890812215

akash_balki@yahoo.com 
Dr Nalini Jayanthi Pushkar Raj Lal  SRM Medical College Hospital and Research Centre  Department of Respiratory Medicine, SRM Nagar,Potheri, Kattankulathur, Kancheepuram, Chennai - 603203
Chennai
TAMIL NADU 		 9444226783

nalinijayanthi59@gmail.com 
Dr Samir Gami  Unique Hospital Multispeciality and Research Institute  Clinical Research Department, Basement, Opp. Kiran motor, behind civil char rasta, near sosyo circle, canal road, Surat- 395002
Surat
GUJARAT 		 9925276708

Samirgami.dr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee, Unique Hospital Multispeciality & Research Institute, Surat  Approved 
IEC Maharaja Agrasen Hospital, Maharaja Agrasen Superspeciality Hospital, Jaipur  Approved 
Institutional Human Ethics Committee GMERS Medical College and Hospital, Vadodara  Approved 
Orange City Hospital & Research Institute, Nagpur  Approved 
Shree Hospital Ethics Committee, Nagpur  Approved 
SRM Medical College Hospital and Research Centre, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol)  06 hours : Single Dose : Max. 24 Hours wash out period : 4 Puffs 
Comparator Agent  Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol)  06 hours : Single Dose : Max. 24 Hours wash out period : 4 Puffs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or non-pregnant, non-lactating female subjects (18-65 years of age).
2. Moderate-to-severe asthma subjects based on NAEPP guidelines.
3. FEV1 within 40-70% of the predicted at screening visit.
4. Reversible airway obstruction demonstrated by an improvement of 15% or more in FEV1 30 minutes after inhalation of two puffs
(0.18 mg) of Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol).
5. Nonsmoker for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years) before that.
6. Willing to provide written informed consent to participate in this study.
7. History of asthma since at least last one year.
8. History of stable asthma a month prior to screening.
9. Subject must be able to demonstrate correct use of the metereddose inhaler (MDI) using the Vitalograph Aerosol Inhalation Monitor.
10. Able to comply with all study requirements and procedures.
 
 
ExclusionCriteria 
Details  1. Known intolerance or hypersensitivity to any components of the albuterol MDI.
2. Intolerance to aerosolized β2-adrenergic agonists.
3. Prior treatment with systemic corticosteroids during the last 3months or subjects who are currently taking oral corticosteroids.
4. Use of long-acting β2-agonists in last 2 weeks prior to randomization.
5. Require continuous treatment with monoamine oxidase inhibitors, tricyclic antidepressants or β-blockers (administered by any route).
6. Dosage of any required inhaled corticosteroids, cromolyn and/or
nedocromil are not stable for at least four weeks prior to the screening. Subjects requiring subsequent dosage adjustment of
these drug products during the study will be discontinued from the study.
7. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the
study.
8. History of life-threatening asthma in the last three years, or ED (Emergency Department) visit or hospitalization for asthma in the
last 12 months.
9. History of frequent exacerbations in the previous year.
10. Subjects whose asthma suspected to have been exclusively seasonal.
11. Other co-morbid respiratory and sinus diseases like tuberculosis, bronchitis, emphysema, COPD.
12. Inability to tolerate or unwillingness to comply with required washout periods or temporary withdrawal for all applicable
medications and xanthine containing foods and beverages prior to screening and each study period.
13. Known or suspected substance abuse (e.g. Alcohol, marijuana, etc.) and /or any other criteria according to the investigator which may affect subject’s safety or study results
14. Inability to tolerate temporary withdrawal of current asthma medication.
15. History of status asthmaticus, cystic fibrosis or bronchiectasis.
16. Abnormal prolongation of QT-interval and/or ECG abnormalities ofclinical relevance.
17. Subjects with abnormal serum potassium value, which is clinically significant as per the opinion of investigator.
18. History of clinically significant cardiovascular, renal, neurologic,
liver or endocrine dysfunction which in the opinion of the investigator, may put the subject at risk because of participation in
the study, or influence the results of the study, or cause concern regarding the subject ability to participate in the study.
19. Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception.
20. Subjects with known positivity for human immunodeficiency virus (HIV), HBsAg and/or HCV.
21. Subject having night shift work for 1 week prior to screening.
22. Participation in any investigational drug study within 30 days prior to screening.
23. Institutionalized subjects.
24. Any other criteria according to the investigator which may compromise subject’s safety or study results.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Baseline adjusted average area-under-the-effect curve calculated from the zero time to six hours(AUEC0-6h)  7 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Baseline adjusted average area-under-the-effect curve calculated from the zero time to four hours (AUEC0-4h).
Baseline adjusted maximum FEV1 (FEV1max) 		 7 Weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   21/10/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

A Bioequivalence Study, to compare the bronchodilating effect of Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) of Deva Holding A.S. with Proair® HFA Albuterol Sulfate Inhalation Aerosol (90 mcg/actuation as Albuterol) in Adult Asthmatics & to evaluate the safety and tolerability of investigational products.


 
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