Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000348550
Ethics application status
Not yet submitted
Date submitted
8/08/2006
Date registered
14/08/2006
Date last updated
14/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Tolerability of a nasal spray in patients with Chronic allergic or nonallergic rhinitis
Scientific title
Active-Controlled Trial of the Safety and Tolerability of MP03-33 (Nasal Spray) in Patients with Chronic Allergic or Nonallergic Rhinitis
Secondary ID [1] 288 0
Medpointe Pharmaceuticals: Clinical Protocol 432
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic allergic or nonallergic rhinitis 1318 0
Condition category
Condition code
Inflammatory and Immune System 1404 1404 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to evaluate the safety and tolerability of MP03-33 with chronic use (two sprays morning and evening) over a 1-year period in patients with chronic allergic or nonallergic rhinitis.
Intervention code [1] 1267 0
Treatment: Drugs
Comparator / control treatment
Commercially available azelastine hydrochloride nasal spray will serve as an active control.
Control group
Active

Outcomes
Primary outcome [1] 1925 0
Safety and tolerability as measured by the frequency of patient reported adverse events.
Timepoint [1] 1925 0
At 1 year
Primary outcome [2] 1926 0
Direct visual examination of the nasal mucosa with specific attention to possible nasal irritation.
Timepoint [2] 1926 0
Performed by investigative site at office visit
Secondary outcome [1] 3382 0
Adherence to therapy as measured by the daily diary card.
Timepoint [1] 3382 0
1yr
Secondary outcome [2] 3383 0
Efficacy as measured by mini-Rhinitis Quality of Life Questionnaire ( mini-RQLQ).
Timepoint [2] 3383 0

Eligibility
Key inclusion criteria
a. An established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR). Patients with a seasonal allergic component may also be included, provided that they have had significant symptoms outside the allergy seasons. b. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent.c. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.d. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor’s medical officer.e. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit adjustments to regimen following a brief period of missed injections does not preclude participation).
Minimum age
12 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study.b. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)c. Women who are pregnant or nursing.d. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. e. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.f. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease.g. Patients with a known history of alcohol or drug abuse.h. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study.i. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures.j. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open Label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1537 0
Commercial sector/Industry
Name [1] 1537 0
MedPointe Pharmaceuticals
Country [1] 1537 0
Primary sponsor type
Commercial sector/Industry
Name
MedPointe Pharmaceuticals
Address
Country
United States of America
Secondary sponsor category [1] 1351 0
None
Name [1] 1351 0
NIL
Address [1] 1351 0
Country [1] 1351 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
The objective of this study is to evaluate the long-term safety and tolerability of MP03-33, a nasal spray,over a 1-year period in patients with chronic allergic or nonallergic rhinitis. Commercially available azelastine hydrochloride nasal spray will serve as an active control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35201 0
Address 35201 0
Country 35201 0
Phone 35201 0
Fax 35201 0
Email 35201 0
Contact person for public queries
Name 10456 0
Dr Richard Spivey (Director)
Address 10456 0
MedPointe Pharmaceuticals Australia Pty Ltd.
c/o Blake Dawson Waldron
225 George Street
SYDNEY NSW 2000
Country 10456 0
Australia
Phone 10456 0
(732) 564-2349
Fax 10456 0
Email 10456 0
rspivey@medpointepharma.com
Contact person for scientific queries
Name 1384 0
Dr Richard Spivey (Director)
Address 1384 0
MedPointe Pharmaceuticals Australia Pty Ltd.
c/o Blake Dawson Waldron
225 George Street
SYDNEY NSW 2000
Country 1384 0
Australia
Phone 1384 0
(732) 564-2349
Fax 1384 0
Email 1384 0
rspivey@medpointepharma.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.