CTRI/2013/01/003334 [Registered on: 29/01/2013] Trial Registered Prospectively
Last Modified On:
16/12/2013
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effect of FDC of Azelastine and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis (symptoms similar to those of a cold such as runny nose and sore throat, caused by an allergic reaction to an allergen such as dust, plant pollens or animal dander)
Scientific Title of Study
A Multicenter, Open-Label, Randomized, Parallel-Group, Comparative Study To Evaluate Efficacy, Safety and Tolerability of Fixed Dose Combination of Azelastine and Mometasone Nasal Spray Compared to Azelastine Nasal Spray and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2011/015/III; version 2.0 dated: 30.10. 2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Piyush Agarwal
Designation
Deputy General Manager
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
Mumbai MAHARASHTRA 400099 India
Phone
912240189999
Fax
Email
piyusha@glenmarkpharma.com
Details of Contact Person Public Query
Name
Dr Shailendra Sachan
Designation
Manager- Medical Writing
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
Thane MAHARASHTRA 400709 India
Phone
912267720000
Fax
Email
shailendrasachan@glenmarkpharma.com
Source of Monetary or Material Support
Glenmark Pharmaceuticals Ltd
Primary Sponsor
Name
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd,
Glenmark House, B D Sawant Marg
Chakala, Andheri (East), Mumbai, India-400099
Department of Chest Diseases, New BEL Road, MSRIT Post, Bangalore 560054 Bangalore KARNATAKA
918040503098
kotnur.rao@gmail.com
Dr Sandeep Gupta
M.V. Hospital and Research Center
Dept of Respiratory Medicine & Allergy, 314/30, Mirza Mandi,
Chowk, Lucknow- 226003,
Uttar Pradesh, India.
Lucknow UTTAR PRADESH
918400388966
sandeepkumar.gupta@rediffmail.com
Dr Chetan Patil
Muktai Hospital
Plot No 11, Shivaji Nagar,
Opp. Fame Adlabs,
Nashik-Pune Road,
Nashik 422066
Maharashtra, India
Pune MAHARASHTRA
919822651494
patilchetan@yahoo.com
Dr Vipul Patadia
Nilkanth Hospital
2,Kumar Flats, Nr. Indian Bank,
Daxini Road, Maninagar, Ahmedabad 380008, Gujarat, India
Ahmadabad GUJARAT
919825125175
vipulpatadia@hotmail.com
Dr Pramod Joshi
Niramaya Hospital
Survey No. 4742,Behind Jai Hind Petrol Pump, Chinchwad, Pune-411019 Pune MAHARASHTRA
918055773135
niramaya_chinchwad@yahoo.co.in
Dr Balkrishna Tayde
NKP institute of Medical Sciences & research Centre
Department of Pulmonary Medicine,NKP institute of Medical Sciences & research Centre
and Lata Mangeshkar Hospital,
Digdoh Hills, Hingna, Nagpur
Nagpur MAHARASHTRA
919422118730
botayade123@gmail.com
Dr Rajesh Chavan
Noble Hospital
1st Floor,
153, Magarpatta City Road,
Hadapsar, Pune: 411013.
Pune MAHARASHTRA
1. Fixed Dose Combination of Azelastine hydrochloride and Mometasone furoate Nasal Spray
The dose is 1 or 2 sprays per nostril once or twice daily for two weeks
Comparator Agent
1. Azelastine Nasal Spray.
The dose is 1 spray per nostril twice daily for two weeks.
Comparator Agent
2. Mometasone Nasal Spray.
The dose is 2 sprays per nostril once daily for two weeks.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients age ≥12 and ≤ 65 years inclusive of either sex.
2. The combined score of nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) must be at least 6; and nasal congestion severity score must be at least 2 at screening.
3. Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season and/or exhibiting a positive skin prick test
4. Patient with ability to understand and sign written informed consent form, which must have been obtained prior to screening. Subjects under the legal age of consent must have provided assent and have had the written informed consent of the parent or guardian.
ExclusionCriteria
Details
1. Pregnant or lactating women.
2. Patients with known hypersensitivity to any of the components of the formulation.
3. Patients with a history of anaphylaxis and/or other severe local reaction(s) to skin testing
4. Patients with alcohol or drug dependence.
5. Patients with perennial rhinitis with little or no seasonal exacerbations; non-allergic rhinitis or ocular infection within 3 weeks before the screening.
6. Patients with documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip or Rhinitis Medicamentosa as determined by the investigator.
7. Patients with a history of psychiatric illness.
8. Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal air flow.
9. Patients with an active pulmonary disorder, upper respiratory tract or sinus infection that required antibiotic therapy at least 14 day prior to the Screening Visit or a viral upper respiratory infection within 7 days before the Screening Visit.
10. Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving monoamine oxidase (MAO) inhibitor therapy.
11. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject’s participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism or excretion of the study drug or interfere with the subject’s ability to complete or reliably complete the patient’s diary.
12. Patients who have participated in any clinical trial in the past 1 month
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean change in Total Nasal Symptoms Score from Baseline to End of treatment.
Time Point: 14 days (two weeks).
Secondary Outcome
Outcome
TimePoints
Mean change in individual symptom scores from Baseline to End of treatment.
Time Point: 14 days (two weeks).
Patients Self Evaluation for overall Response to Treatment at the End of treatment.
Time point: 14 days (two weeks).
Mean change in Rhinoconjunctivitis Quality-of-Life Score (RQOL) from Baseline to End of treatment.
Time point: 14 days (two weeks).
Target Sample Size
Total Sample Size="560" Sample Size from India="560" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is open label, randomized, active controlled, parallel-group, comparative study. Study will enroll 560 patients with seasonal allergic rhinitis from different centers from India.
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in equal ratios to receive either of the products for two weeks. The primary objective of the study is to see the mean change in total nasal symptom score at the end of treatment. Secondary objective includes mean change in nasal and non-nasal symptom score and mean change in RQOL at 2 weeks.
During the study, there will be 5 study visits for efficacy, safety and tolerability assessment.