CTRI/2022/12/048206 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On:
30/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A randomized, phase 2 dose finding study of itraconazole as dry powder for inhalation in adult patients with Acute bronchopulmonary Aspergillosis (ABPA)
Scientific Title of Study
A Randomized, Double Blind, Placebo-Controlled, Prospective, Multicentre, Phase 2, Dose-Finding Study of Itraconazole Administered as a Dry Powder For Inhalation (PUR1900) In Adult Subjects With Asthma And Allergic Bronchopulmonary Aspergillosis (ABPA)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CP/03/22, Version 01, dated 23/05/2022
Protocol Number
Version 01, dated 23/05/2022
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jaideep Gogtay
Designation
Executive Vice President, Global Chief Medical Officer.
AIG Hospitals, Room no.2, 7th Floor Tower B, Department of Pulmonology, 1-66/AIG/2 to 5, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032, India. Hyderabad TELANGANA
8978033889
vishwanathgella@gmail.com
Dr Anant Mohan
All India Institute of Medical Sciences
All India Institute of Medical Sciences, Room no. 5, Portable Cabin, Department of Pulmonary medicine, critical care and sleep disorders, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India New Delhi DELHI
9810048204
anantmohan@yahoo.com
Dr Rennis Davis
AMALA INSITIUTE OF MEDICAL SCIENCES
DEPT. OF PULMONARY MEDICINE, PULMONARY MEDICINE, AMALA NAGAR P.O, THRISSUR
KERALA - 680555, INDIA
Thrissur KERALA
9847485785
rennis@rediffmail.com
Dr Girija Nair
Dr. D.Y. Patil Medical College Hospital & Research Centre
Pulmonary Medicine department, Chest & TB division, Sector-5, Nerul, Navi Mumbai, Maharashtra-400706, India Thane MAHARASHTRA
9324294457
girijapn@hotmail.com
Dr Jyoti Bajpai
King Georges Medical University
Department of Respiratory Medicine, Research Room, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 Lucknow UTTAR PRADESH
7897138335
jyotibajpai33@gmail.com
Dr Pajanivel
Mahatma Gandhi Medical College & Research Institute (MGMCRI),
Department of Pulmonary medicine, Respiratory Division, Hospital Building, 1st Floor, Pondicherry- Cuddalore ECR Main Road, Pillayarkuppam, Puducherry-607 402, India Pondicherry PONDICHERRY
9443493122
pajanivelr@mgmcri.ac.in
Dr Dhruva Chaudhry
Post Graduate Institute of medical education and research
Pandit Bhagwat Dayal Sharma, PGIMS, Room No. 17, Department of Pulmonary and Critical Care Medicine, Medical Road, Rohtak, Haryana 124001, India. Rohtak HARYANA
9416051616
dhruvachaudhry@yahoo.co.in
Dr Ritesh Agarwal
Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research, Department of Pulmonary Medicine, 4th Floor, F- Block, Nehru Hospital, PGIMER. Sector-12, Chandigarh (India) 160012, India. Chandigarh CHANDIGARH
Sanjivini Hospital and Research Center, Department of Pulmonology, CP-23, Viraj Khand, Near Hahnemann Chauraha, Gomti Nagar, Lucknow 226010 Uttar Pradesh, India Lucknow UTTAR PRADESH
9415007110
smsdgupta@gmail.com
Dr Akash Balki
Shree Hospital & Critical care centre
Shree Hospital & Critical care centre,Room No. 3, Respiratory Research Unit, 3rd floor, 799, Om Nagar, Opp.Tajshree Building, Sakkardara Square, Nagpur 440009, Maharashtra, India Nagpur MAHARASHTRA
9890812215
akash_balki@yahoo.com
Dr Raja Dhar
The Calcutta Medical Research Institute & C K Birla Hospital
The Calcutta Medical Research Institute & C K Birla Hospital, Department of Pulmonology, Level 1, 7/2 Diamond Harbour Road, Kolkata-700027, West Bengal, India Kolkata WEST BENGAL
9831855512
docaardee@yahoo.com
Dr Rohit Kumar
Vardhman Mahavir Medical College & Safdarjung Hospital
Vardhman Mahavir Medical College & Safdarjung Hospital, Room 614, Department of Pulmonary medicine, Heart command center building, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029, India New Delhi DELHI
9911218081
dr.rohitkumar.dm.aiims@gmail.com
Dr Venkata Nagarjuna Maturu
Yashoda Hospital
Yashoda Healthcare Services Pvt Ltd Hitech City, Cyber Towers to JNTU Road, Hyderabad, -500 084, Telangana, India
Hyderabad TELANGANA
Ethics Committee- AIMS THRISSUR, Amala Institute of Medical Science, Thrissur 680555
Approved
Institute Ethics Committee All India Institute of Medical Sciences Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar, New Delhi-29, Delhi, India
Approved
Institutional Ethic Committee, PGIMS UHS Rohtak
Approved
Institutional Ethics Committe, Office of Research Cell, Administrative Block, King George’s Medical University, Lucknow226003e,
Approved
Institutional Ethics Committee Asian Institute of Gastroenterology 3 rd Floor, 6-3-661, Somajiguda, Hyderabad Telangana - 500082 India
Approved
Institutional Ethics Committee D Y Patil Medical College Sector 5 Nerul Navi Mumbai Thane Maharashtra - 400706 India
Approved
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research Room No. 6006, IEC Office, 6th Floor P N Chuttani Block, Chandigarh, India
Approved
Institutional Ethics Committee The Calcutta Medical Research Institute, 7/2 Diamond Harbour Road, Kolkata, West Bengal, India
Approved
Institutional Ethics Committee VMMC and SJH VMMC And SAFDARJUNG HOSPITAL, Ring Road, Ansari Nagar, New Delhi, Delhi, India
Approved
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research
Approved
lnstitutional Human Ethics Committee Mahatma Gandhi Medical College Research institute, No.45-A, Pondy- Cuddalore Main Road, Pillaiyarkuppam, Pondicherry, Puducherry-607402, lndia
Placebo dry powder for Inhalation administered once daily for 16 weeks
Intervention
PUR1900
20 mg, 40 mg dry powder for Inhalation administered once daily for 16 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subjects with confirmed asthma and allergic bronchopulmonary aspergillosis (ABPA).
2. ABPA patients who at screening are symptomatic and have IgE ≥ 1000 IU/ml and ACQ 7 score > 1.5 and/or have been on systemic glucocorticoids < 10 mg/day of prednisolone for at least the past one month.
3. Subjects able to perform valid reproducible spirometry with demonstration of pre-bronchodilator FEV1 ≥ 50% to < 85% of predicted normal for age, sex, race, and height at a screening visit.
ExclusionCriteria
Details
1. Subjects who have used systemic azole antifungal agent in the past 3 months before first dose of study drug.
2. Subjects with a 12-lead ECG demonstrating a mean QT interval corrected by the Fridericia formula (QTcF) >450 ms for a male subject or >470 ms for a female subject at screening (A repeat triplicate ECG is allowed if a mean QTcF >450 msec is recorded at Visit 1).
3. Subjects on any anti-IgE (omalizumab) or anti-interleukin-5 biologics or any other monoclonal antibodies for asthma in the 6 months before the first dose of study drug.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1 Effect of daily administration of PUR1900 in adult subjects with asthma and ABPA on measures of efficacy (at week 4, 8, 12 and 16 from baseline) including lung function, asthma control and quality of life:
2 To determine the dose of PUR1900
3 To evaluate the safety and tolerability of PUR1900 administered in adult subjects with asthma and ABPA.
1. Week 4, 8, 12 and 16 from baseline
2 Week 16 from baseline.
3. Across all visits from baseline visit.
Secondary Outcome
Outcome
TimePoints
No secondary endpoint.
No secondary endpoint.
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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)?
Response - NO
Brief Summary
Subjects with confirmed asthma and ABPA who give a voluntarily written, signed, dated, informed consent will be screened for study participation. Eligible subjects will enter two weeks of run-in period. After confirmation of eligibility for randomization, subjects will be randomly assigned into 1 of 3 arms- PUR1900 20 mg, PUR1900 40 mg, or placebo, using a 2:2:1 randomization scheme. At treatment visits: vital signs, clinical examination, laboratory investigations, ACQ-7, ACQ 6, AQLQ, pre-dose and 1-hour post-dose (of investigational product) spirometry for FEV1, 12-lead ECG, Chest X-ray and serum total IgE, checking of inhaler technique and overall wellbeing. Subjects will be provided a Peak Flow Meter (PFM) and a Subject diary. After completion of study treatment, subjects will enter a post-treatment follow up period of 4 weeks and safety and other investigations will be carried out at week 20. Subjects will be monitored for adverse events throughout the study period.