CTRI/2020/02/023237 [Registered on: 11/02/2020] Trial Registered Prospectively
Last Modified On:
07/12/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A study to assess the safety and efficacy of fixed dose combination of Montelukast 10 mg plus Acebrophylline SR 200 mg tablet in patients having bronchial asthma
Scientific Title of Study
An open label, multi-centric, prospective clinical trial to evaluate safety and efficacy of fixed dose combination of Montelukast 10 mg plus Acebrophylline SR 200 mg tablet in patients having bronchial asthma in India
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ICR/18/006 Version No. 2.0, Dated 25/APR/2019
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Department of Pulmonology & Sleep Medicine, Apollo Hospitals, Jubilee Hills, Hyderabad – 500096, Telangana, India. Hyderabad TELANGANA
9866343831
andiv225@yahoo.com
Dr Kartikeya Parmar
B.J, medical college and Civil hospital
Department of Medicine,
Division of Internal medicine
Room No. D4
B.J, medical college and Civil hospital, Asarwa-Ahmedabad-380016, Gujarat, India. Ahmadabad GUJARAT
Grant Government Medical College and Sir J J Group of hospitals
Department of Internal Medicine, OPD No 20, Old Building, Grant Government Medical College and Sir J J Group of hospitals, Byculla Mumbai-400008 Mumbai MAHARASHTRA
9870456888
drhemantgupta@hotmail.com
Dr Rakhi Ludam
Institute of Medical Sciences & SUM Hospital
4th floor, Department of Pulmonary Medicine, Institute of Medical Sciences & SUM Hospital,
Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha.
Khordha ORISSA
9437258118
drrakhi01@gmail.com
Dr Ranjit Kumar Haldar
IPGME&R and SSKM HOSPITAL
Room No.- 6, Department of Chest Medicine, IPGME&R and SSKM HOSPITAL, 244, A.J.C. BOSE
ROAD KOLKATA-700020
Kolkata WEST BENGAL
8777572323
haldar.ranjit@gmail.com
Dr S Narasinga Rao
King George Hospital
Department of Medicine,Rajendra prasad Ward, Maharani Peta, Visakhapatnam- 530002 Visakhapatnam ANDHRA PRADESH
09848136704
drnarasingaraoresearch@gmail.com
Dr Keyurkumar Mayankbhai Patel
Lotus Multispeciality Hospital
Block N, Krupa Residency, Motera Stadium Road, Motera- Sabarmati,Ahmedabad-380005, Gujarat, India Ahmadabad GUJARAT
8866674417
lotushospital.79@gmail.com
Dr Vaibhav Daulat Pandharkar
Noble Hospital Pvt Ltd
OPD no. 18, Ground Floor, Department of Pulmonology, Noble hospital Pvt. Ltd, 153 A,Magarpatta City Road, Hadapsar (India)-Pune, Maharashtra, India 411013 Pune MAHARASHTRA
9923111646
nhcrd09@gmail.com
Dr Mayank Agrawal
Om Research Center, Om Surgical Center & Maternity Home
SA 17/3, P-4, Sri Krishna Nagar colony, Opp Petrol pump, near Surabhi Hotel, Ghazipur Road, Paharia, Varanasi, Uttar Pradesh-221007, India. Varanasi UTTAR PRADESH
Head of Department of General Medicine Room, Department of General Medicine, Near Superinderindent Department, Main Building, Osmania General Hospital, Afzalgunj, Hyderabad-500012. Hyderabad TELANGANA
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents,
Intervention / Comparator Agent
Type
Name
Details
Intervention
FDC of Montelukast 10 mg and Acebrophylline SR 200 mg tablet
Dosage and Administration- Each patient will receive Montelukast 10 mg plus Acebrophylline SR 200 mg tablet to be consumed orally once daily in the evening for 84 days with or without food.
Take tablets whole, Do not chew
Comparator Agent
NOT APPLICABLE
NOT APPLICABLE
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Male or female patient with age 18 - 65 years (both inclusive)
2.Patient having confirmed diagnosis of asthma as per GINA 2018 guideline since at least 3 months prior to screening
3.Patient having current sign/symptoms of asthma or need for SABA more than twice a week
4.Patient who is suitable to take Montelukast and Acebrophylline as per GINA 2018 guideline
5.Female patient of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test. Effective contraceptive include (e.g. barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable methodâ€
6.Except asthma disorder patient is judged to be in general good health to participate in trial based on medical history and physical examination as assessed by the Investigator
7.Written informed consent signed by patient and willing to comply with the study procedure
ExclusionCriteria
Details
1.Pregnant or lactating female patient
2.Hospitalization due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit)
3.Patient with clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigators
4.Patient has a history of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to enrollment
5.Patient who had received leukotriene antagonist and/ or Acebrophylline within 3 days of enrolment
6.Patient with concurrent, previous or possible alcohol dependence, drug dependence or narcotic addiction as per DSM-5
7.Patient who have earlier participated in any other clinical trial within three months of screening
8.Patient with a known history of clinically significant (including but not limited to) acute myocardial infarction, impaired hemodynamics, psychiatric, hepatic or/and renal disorders, Ambroxol allergy, GI disorders, phenylketonuria, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax convulsion, arrhythmia, CAD, cardiac insufficiency and hyperthyroidism
9.Patient with known history of Hypersensitivity to Acebrophylline or Montelukast or any other leukotriene antagonists or asprin or theophylline or any other xanthine derivative
10.History of hepatitis B, hepatitis C or HIV infection
11.Patient with type 2 diabetes (HbA1c > 9 % at screening)
12.Patient with current history of uncontrolled hypertension (SeSBP ≥ 140 and/ or SeDBP ≥ 90 mm of Hg)
13.Current smoker or past smoker with a smoking history of ≥ 10 pack years
14.Patient with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug
15.Patient judged unfit for this study by investigator
16.Investigator, study personnel, sponsor representatives and their first degree relatives
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Primary Outcome measure: (Safety)
Proportion of participants with adverse events and serious adverse events
Time frame: 84 days
Secondary Outcome
Outcome
TimePoints
Change in Trough Forced Expiratory Volume in 1 second (FEV1) from baseline to the end of treatment
Time frame: 28, 56, 84 days
Change in ASUI score from baseline
Time frame: 28, 56, 84 days
Change in Forced Vital Capacity from baseline
Time frame: 28, 56, 84 days
Number of rescue medication (Short acting beta-2 agonists) used during study period. It shall be captured by Mean of occasions (not puffs) of SABA use per day, averaged over 1 week
Time frame: 28, 56, 84 days
Target Sample Size
Total Sample Size="206" Sample Size from India="206" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a phase IV, multi-centric, open-label, prospective study to
evaluate safety and efficacy of fixed dose combination of Montelukast 10 mg
plus Acebrophylline SR 200 mg tablet in patients having bronchial asthma. Approximately
206 Male or female patients with age 18 - 65 years having confirmed diagnosis
of asthma as per GINA 2018 guideline since at least 3 months prior to screening
and who are having current sign/ symptoms of asthma or need for SABA more than
twice a week will be enrolled in this study. Study consists of 05 visits (one
Screening Visit, one Baseline Visit, two Follow up Visits and one End of
Treatment Visit). Study duration will be of 14 weeks, including 02 weeks of
screening period (maximum) and treatment duration of all enrolled patients will
be of 12 weeks.
Primary
Outcome measure: (Safety)
·Proportion
of participants with adverse events and serious adverse events [Time frame: 84
days]
Secondary outcome
measure(s): (Efficacy)
·Change in Trough Forced
Expiratory Volume in 1 second (FEV1) from baseline to the end of treatment.
[Time frame: 28, 56, 84 days]
·Change in ASUI score
from baseline [Time frame: 28, 56, 84 days]
·Change in Forced Vital
Capacity from baseline. [Time frame: 28, 56, 84 days]
Number of rescue medication (Short acting beta-2
agonists) used during study period. It shall be captured by Mean of occasions
(not puffs) of SABA use per day, averaged over 1 week [Time frame: 28, 56, 84
days]