CTRI/2024/11/076181 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On:
28/12/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Study to Demonstrate the Bioequivalence of Albuterol Inhalation Aerosol(Macleods Pharma Vs Teva pharma) in Adult Patients with Stable Mild Asthma.
Scientific Title of Study
A Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd.) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) in Adult Patients with Stable Mild Asthma.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT-060-ALBU-2024, Version no. 1.0, Dated 21 Jun 2024
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ashish Mungantiwar
Designation
Executive President Medical Services And Head Clinical Trials
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd R and D III Plot No 18 Street No 9
Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA
400093 India
Mumbai (Suburban)
MAHARASHTRA
400093
India
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
drashish@macleodspharma.com
Details of Contact Person Scientific Query
Name
Dr Ashish Mungantiwar
Designation
Executive President Medical Services And Head Clinical Trials
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd R and D III Plot No 18 Street No 9
Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA
400093 India
Mumbai (Suburban)
MAHARASHTRA
400093
India
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
drashish@macleodspharma.com
Details of Contact Person Public Query
Name
Priyanka Shrivastava
Designation
Head of Clinical Operations
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd R and D III Plot No 18
Street No 9
Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA
400093 India
Mumbai (Suburban)
MAHARASHTRA
400093
India
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
priyankas@macleodspharma.com
Source of Monetary or Material Support
Macleods Pharmaceuticals Ltd R and D III Plot No 18 Street No 9
Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA
400093 India
Mumbai (Suburban)
MAHARASHTRA
400093
India
Primary Sponsor
Name
Ms Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd, 3rd floor, Atlanta Arcade, Church Road, near Leela hotel, Andheri Kurla road, Andheri east, Andheri India - 400059
Ground Floor, Dr Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre, Rutubhai Adani Arogyadham, Dr Jivraj Mehta Marg, Ahmedabad 380007 Ahmadabad GUJARAT
07926639840
drvsheth@gmail.com
Dr Maheshkumar Anandbhai Vaghani
Global Hopsital
OPD Room no.1, 4th Floor Beside Navjivan Sarthana Jakatnaka Surat Surat GUJARAT
02612571116
drmahesh11vaghani@gmail.com
Dr Pradipkumar Hiraji Damor
Harmony Hospital
301 Puskar Icon Nr. Shukan Cross road Nikol Naroda Road above Croma New India Colony Nikol Ahmedabad Gujarat 382350 Ahmadabad GUJARAT
9512500822
drpradipdamor.researchcr@gmail.com
Dr Parth Patel
Hitech Multispeciality Hospital
Room no. 04, Ground Floor, Sector 3-D plot no.1180, Gh Road, Nr Gh-11/2 Bus stand Gandhinagar GUJARAT
07923240555
hitech.clinicalresearch@gmail.com
Dr Mitul Chaudhari
J K Orthopaedic Hospital
Behind Mehta Petrol Pump Near S T Stand, Girdharnagar Himmatnagar 383001 Sabar Kantha GUJARAT
02772241326
mitulchaudhari91@gmail.com
Dr Deepali Kamdar
Jaydeep Hospital
Consulting Room First Floor, Nr St. Xaviers Loyoala school, Opp Kamnath Mahadev, Darpan six roads, Naranpira, Ahmedabad-380013, Gujarat, India Ahmadabad GUJARAT
OPD Room, Ground Floor, Kanoria Hospital and Research Centre, Airport- Gandhinagar Highway, village Bhat. Gandhinagar-382428,Gujarat India. Ahmadabad GUJARAT
07923969274
jkanand09@gmail.com
Dr Ashish Tukaram Nikhare
Lata Mangeshkar Multispeciality Hospital
Departent of Pulmonology, Near YMCA complex, Maharajbagh Road, Sitabuldi Nagpur 440012 Nagpur MAHARASHTRA
07122530347
ashoonikh@gmail.com
Dr Dnyandeep Sarpe
Lifepoint Multispeciality Hospital
Sr. No. 145 Multispeciality hospital,Wakad, PCMC, 1, Mumbai Pune Bypass Rd, near Sayaji Hotel,
Wakad, Pimpri-Chinchwad, Maharashtra 411057 Pune MAHARASHTRA Pune MAHARASHTRA
020-66434366
sarpednyandeep@gmail.com
Dr Pankaj Vyas
Namostute Hospital
Namostute Hospital First Floor Room no. 102 Sector-6D, Near GH-3, Opposite Civil Hospital Gandhinagar 382006 Gujarat India Gandhinagar GUJARAT
07923237000
drpankajvyas.researchcr@gmail.com
Dr Ashish Goyal
Orchid Hospital
Orchid Specialty
Hospital, Basement,
L-Square, Porwal Road,
Sr. No. - 282/3/3, Off.
Dhanori Jakat Naka,
Lohgaon, Pune Pune MAHARASHTRA
Albuterol Sulfate HFA inhalation aerosol 90 mcg per actuation By Teva Pharmaceuticals
Intervention
Albuterol Sulfate
Albuterol Sulfate inhalation aerosol of Macleods Pharmaceuticals 90 mcg per actuation
Comparator Agent
Reference Placebo
Matching Placebo of Reference
Comparator Agent
Test Placebo
Matching Placebo of Test
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
(1.) Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive). (2.) Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines. (3.) Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date. (4.) Pre-bronchodilator forced expiratory volume in one second (FEV1) more than or equal to 80 percent of predicted. (5.) Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 1.56 mg per mL using AeroEclipse II BAN and 1-minute tidal breathing method at Screening MCT A (6.) The more than or equal to 20 percent reduction in FEV1 at Screening MCT A relative to post-saline FEV1 should be obtained above the lowest methacholine concentration. (7.) At Screening MCT-B, subjects should have at least four-fold increase in PC20 over Screening MCT-A (8.) At Screening MCT -B, the more than or equal to 20 percent reduction in FEV1 relative to post saline FEV1 must be obtained up to methacholine concentration 24.96 mg per mL (9.) Non-smokers for at least six months prior to screening visit and a maximum smoking history of five-pack years (the equivalent of one pack per day for five years). (10.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must have negative result for urine pregnancy test (11.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must agree to the use of a reliable and medically acceptable method of contraception throughout the duration of the study (12.) Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit using hormonal contraception must be on the same hormonal contraceptive for at least thirty days before the screening period and must be continued same throughout the study. (13.) Able to provide signed written informed consent and willing to comply with all aspects of the clinical study protocol
ExclusionCriteria
Details
1.Subjects with FEV1 less than 1.5L during methacholine challenge test
2.Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
3.History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season
4.History of cystic fibrosis, bronchiectasis or other respiratory diseases other than asthma (e.g., COPD, interstitial lung disease)
5.Treatment in an emergency room or hospitalization for acute asthmatic symptoms within past three months prior to screening visit
6.Need for daily oral corticosteroids within past three months prior to screening visit
7.History of life-threatening asthma leading to hospitalization within the past 1 year prior to screening visit
8.Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI)
9.Uncontrolled hypertension (systolic BP more than 200 mmHg, or diastolic BP more than 100Â mmHg)
10.History or evidence of myocardial infarction or stroke
11.History of known aortic aneurysm
12.Current use of cholinesterase inhibitor medication (for myasthenia gravis)
13.Clinically significant ECG recording at screening such as flattening of T wave, prolongation of QTc interval ( more than 450 milliseconds), and ST segment depression, which in the opinion of the Investigator, would compromise subject’s safety or interfere with the study results
14.History of recent eye surgery or intracranial pressure elevation risk
15.Uncontrolled diabetes (HbA1c greater than or equal to 9%) at screening
16.Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates in the study
17.Presence of any abnormal clinically significant laboratory investigation at screening visit
18.History of paradoxical bronchospasm
19.Has participated in another investigational study or device research study within 30Â days before screening visit date
20.Women are pregnant, breast-feeding, or planning pregnancy during study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To demonstrate pharmacodynamic (PD) bioequivalence (BE) of Albuterol sulfate HFA inhalation aerosol (E.Q. 90 mcg albuterol Base/Inh) (of Macleods Pharmaceuticals Ltd) (TÂ inhalation aerosol) to Albuterol sulfate HFA Inhalation Aerosol (E.Q. 90 mcg albuterol Base/Inh) (distributed by Teva Pharmaceuticals USA, Inc.) (R inhalation aerosol) as assessed by post-dose PC20.
Period 1 to 4
Secondary Outcome
Outcome
TimePoints
To assess the safety profile of the test product compared to that of the reference product. Safety parameters, such as AEs physical examination, vital signs (BP, PR, and body temperature) and laboratory investigations.
Screening Visit to End of study
Target Sample Size
Total Sample Size="144" Sample Size from India="144" 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)
05/11/2024
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
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Prospective, Randomized, Single-dose, Double-blind, Double-dummy, Four-period, Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Inhalation Aerosol 90 mcg of Macleods Pharmaceuticals Ltd. to Albuterol Inhalation Aerosol 90 mcg Teva Pharmaceuticals USA, Inc. in Adult Patients with Stable Mild Asthma.
The Patients will be randomized to get 0 dose, 90 mcg of Reference, 90 mcg of Test or 180 mcg of Reference albuterol dose.