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CTRI Number  CTRI/2019/01/016974 [Registered on: 08/01/2019] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Phase IV Study of Tulobuterol Transdermal Patch in Patients with Asthma or COPD 
Scientific Title of Study   An Open-Label, Non–Comparative Phase-IV Study to Evaluate the Efficacy, Safety and Tolerability of Tulobuterol Transdermal Patch –0.5/1/2 mg (Tuloplastâ„¢) in Patients with Asthma or COPD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZUV/TULO/02/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Limited  
Address  Office No 5119, D wing, 5th floor, Oberoi Garden Estate, Chandivali, Andheri (east)

Mumbai
MAHARASHTRA
400 072
India 
Phone  28472823   
Fax    
Email  medico@zuventus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Limited  
Address  Office No 5119, D wing, 5th floor, Oberoi Garden Estate, Chandivali, Andheri (east)

Mumbai
MAHARASHTRA
400 072
India 
Phone  28472823   
Fax    
Email  medico@zuventus.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhupesh Dewan 
Designation  Director Medical Services 
Affiliation  Zuventus Healthcare Limited  
Address  Office No 5119, D wing, 5th floor, Oberoi Garden Estate, Chandivali, Andheri (east)

Mumbai
MAHARASHTRA
400 072
India 
Phone  28472823   
Fax    
Email  medico@zuventus.com  
 
Source of Monetary or Material Support  
Zuventus Healthcare Limited, Office no 5119, D wing 5th floor Oberoi Garden Estates Chandivali, Andheri East, Mumbai 400072  
 
Primary Sponsor  
Name  Zuventus Healthcare Limited 
Address  Oberoi Garden Estate, Sakinaka, Andheri East, Chandivali Farm Road, Powai Mumbai Maharashtra 400072  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjeev Kumar Verma  King George’s Medical University  1st floor, Department Of Pediatrics, Shah Mina Rd, Chowk
Lucknow
UTTAR PRADESH 		 9455934200

drsanjeev78@gmail.com 
Dr Ravi Koppula  Government Medical College & Government General Hospital (Old RIMSGGH)  1st floor, Department of Pulmonology, Srikakulam, Andhra Pradesh 532 001
Srikakulam
ANDHRA PRADESH 		 7995881980

bioexperts21@gmail.com 
Dr Rajendra Kumar Jenaw  Institute of Respiratory Disease, SMS Medical College  Block A, Ground Floor, OPD 01, Subhash Nagar Road, Subash Nagar
Jaipur
RAJASTHAN 		 9414051338

jenawrk@gmail.com 
Dr Rashid Parvez  Janta Hospital  1st floor, Room no. 101, Near Water Head Tank, Amara Akhari Bypass, Chunar Road
Varanasi
UTTAR PRADESH 		 9560407345

rashidaiims@yahoo.in 
Dr N T Awad  Lokmanya Tilak Municipal Medical College And General Hospital  Department of Respiratory Medicine, 1st floor, RB2 Central Railway Quarters, Sion West, Sion, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA 		 9322252708

nta1960@gmail.com 
Dr Ajoy Krishna Sarkar  Peerless Hospitex Hospital  Clinical Research Department, 2nd Floor, Main block, Peerless Hospitex Hospital and Research Centre, 360, Panchasayar, Kolkata 700094
Kolkata
WEST BENGAL 		 9830006644

ajoysarkar29@gmail.com 
Dr Hansraj Alva  Vinaya Hospital And Research Centre  1st floor, KIMS building, Post Box No. 717, Karangaipady, Mangalore-575003
Dakshina Kannada
KARNATAKA 		 9343562622

hansalva2001@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinical Research Ethics Committee Peerless Hospitex Hospital and Research Centre   Approved 
Ethics Committee Vinaya Hospital & Research Centre  Approved 
IEC Govt Medical college and Gen Hospital  Approved 
Institutional Ethics Committee For Human Research, Lokmanya Tilak Municipal Medical College  Approved 
Institutional Ethics Committee, Research Cell, King Georges Medical University   Approved 
Institutional Ethics Committee, SMS Medical College & Attached Hospital  Approved 
Janta Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J45||Asthma, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Tuloplastâ„¢ (Tulobuterol transdermal patches - 0.5/1/2 mg)  0.5 mg and 1mg patches for pediatric asthma patients, and 2mg patches for children above 9 years of age, adolescents and adult asthma or COPD patients. The patch is to be applied once daily for 4 weeks. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  80.00 Year(s)
Gender  Both 
Details  A. For Children < 6 years of age-
1. Children aged < 6 years or younger with a history of physician diagnosed asthma at the time of giving informed consent
2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of
breath, activity limitation and/or nocturnal awakening
3. Parents or guardians of the patients willing to give informed consent and willing to comply with the clinical study protocol
B. For Children > 6-11 years of age-
1. Children aged > 6 to 11 years with a history of physician diagnosed asthma at the time of giving informed consent
2. Children experiencing more than one of the following symptoms: wheeze, cough, shortness of
breath and/or nocturnal awakening
3. Children who meet one of the following criteria in terms of pulmonary function parameters:
i. The FEV1/FVC ratio less than 0.90
ii. Increase in FEV1 of > 12% predicted (post bronchodilator usage) from baseline, 10-15
minutes after 200-400 mcg salbutamol or equivalent as per GINA 2018
4. Parents or guardians of the patients willing to give written informed consent and willing to comply with the clinical study protocol
5. Children who give assent to participate in the study (Participants of appropriate intellectual maturity should personally sign and date a separately designed, written assent form. For other patients verbal assent is admissible)
C. Asthma (Adolescent and Adult Patients)-
1. Male or female patients aged ≥ 12 years at the time of giving informed consent
2. Patients experiencing more than one of the following symptoms: wheeze, cough, chest tightness,shortness of breath and/or nocturnal awakening
3. Patients who meet one of the following criteria in terms of pulmonary function parameters:
i. FEV1/FVC: less than 0.75
ii. Bronchodilator reversibility: increase in FEV1 of >12% and >200mL from baseline, 10-15
minutes after 200-400 mcg salbutamol or equivalent
4. Patients whose asthma is not controlled by low dose Inhaled Corticosteroids (ICS) alone E.g. Budesonide (200-400 mcg)
5. Patients willing to give written informed consent (parents or guardians in case of adolescent patients; adolescent patients will have to sign an informed assent form) and willing to comply with the clinical study protocol 
 
ExclusionCriteria 
Details  A. For children aged 6 months to 11 years-
1. Patients with a known history of hypersensitivity to the study medication
2. Patients with dermatological diseases, including atopic dermatitis
3. Patients showing evidences of pulmonary infection
4. Major organ disorders like liver or kidney failure
5. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes
6. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with β2 agonists is considered inappropriate)
B. Asthma (Adolescent and Adult Patients)-
1. History of smoking during 6 months preceding enrollment
2. Acute exacerbation of asthma (Patients can be included after stabilization)
3. Patients with dermatological diseases, including atopic dermatitis
4. Patients with respiratory disease other than asthma (e.g., emphysema, bronchiectasis, pulmonary fibrosis, lung cancer, sarcoidosis)
5. Any existing pulmonary infection
6. Female patients who are pregnant or breastfeeding or are planning to get pregnant within 2 months after initiation of the study
7. Illness severe enough to require hospitalization
8. Patients with a known history of hypersensitivity to the study medication
9. Major organ disorders like liver or kidney failure
10. Patients with history of poorly controlled associated diseases such as: heart disease, hypertension,thyroid disorders and diabetes
11. Patients who are otherwise judged to be inappropriate for inclusion in the study by the investigator (for whom treatment with β2 agonists is considered inappropriate) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
-Proportion of patients reporting adverse events during the treatment period
-Global assessment of Tuloplastâ„¢ tolerability by investigators and patients using a 4-point scale
(excellent, good, fair, and poor)
-Proportion of patients requiring rescue medications 		 -Throughout the study duration
-Last Visit (Day 28)
-Throughout the study duration 
 
Secondary Outcome  
Outcome  TimePoints 
-Percentage improvement in the severity of clinical symptoms from baseline of Asthma or COPD at the end of the study (as per GINA 2018 and GOLD 2018)
-Improvement in the lung function parameters (PEF, FEV1, FVC) at the end of the study (except in children 6 years of age who cannot perform spirometry)
-For the children 6 years of age: reduction in airflow obstruction as interpreted from the parameters of impulse oscillometry. (R5, R20, X5, Ax, Fres) 		 -Throughout the study duration
-Throughout the study duration
-Throughout the study duration 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   08/01/2019 
Date of Study Completion (India) 25/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Aim and Objective:
The aim of this clinical study is to investigate the efficacy, safety and tolerability of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg) in patients with Asthma or Chronic Obstructive Pulmonary Disease (COPD).

Primary Objective: 
The primary objective is to evaluate the safety and tolerability of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg)

Secondary Objective:
The secondary objectives of this clinical study is to assess the efficacy of TuloplastTM (Tulobuterol transdermal patches- 0.5/1/2 mg) in improvement of lung function parameters and resolution of the clinical symptoms in patients with Asthma or COPD.

Study Design: 
Prospective, Open label, Multicentric, Non-comparative clinical study.

Estimated Sample Size: 
300 evaluable patients

Test  Product: 
TuloplastTM (Tulobuterol transdermal patches- 0.5 and 1 mg patches for pediatric asthma patients, and 2 mg patches for children above 9 years of age, adolescents and adult asthma or COPD patients) 

Study Duration: 
The study duration will be of 6 weeks [2 weeks run-in i.e. maintainence therapy with ICS alone + 4 weeks treatment with study medication] for pediatric, adolescent and adult asthma patients previously maintained on any other antiasthmatic agents. For COPD patients and asthma patients maintained on ICS alone the study duration will be of 4 weeks.

Study Endpoints: 
Primary Outcomes: 
  • Proportion of patients reporting adverse events during the treatment period.
  • Global assessment of TuloplastTM tolerability by investigators and patients using a 4-point scale (excellent, good, fair and poor)
  • Proportion of patients requiring rescue medications
Secondary Outcomes:
  • Percentage improvement in the severity of clinical symptoms from baseline of Asthma or COPD at the end of the study (as per GINA  2018 and GOLD 2018)
  • Improvement in the lung function parameters (PEF, FEV1, FVC) at the end of the study (except in children less than 6 years of age who cannot perform spirometry)
  • for children less than 6 years of age: reduction in airflow obstruction as interpreted from the parameters of impulse oscillometry (R5, R20, X5, Ax, Fres)

 
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