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Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00783432
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : October 2, 2009
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Meda Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 30, 2008
First Posted Date  ICMJE October 31, 2008
Results First Submitted Date  ICMJE December 29, 2008
Results First Posted Date  ICMJE October 2, 2009
Last Update Posted Date October 6, 2009
Study Start Date  ICMJE July 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
  • Number of Participants Reporting Adverse Events [ Time Frame: 12 months ]
    An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
  • Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. [ Time Frame: baseline and 12 months/ET ]
    Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2008)
  • Frequency of patient-reported adverse events [ Time Frame: 12 months ]
  • Direct visual examination with specific attention to evidence of nasal irritation [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. [ Time Frame: baseline, months 1,3,6,9 and 12/or early termination ]
The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2008)
Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Official Title  ICMJE Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis
Brief Summary The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Allergic Rhinitis
  • Nonallergic Rhinitis
Intervention  ICMJE
  • Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
    548 mcg (2 sprays per nostril) twice a day
  • Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)
    548 mcg (2 sprays per nostril) twice a day
Study Arms  ICMJE
  • Experimental: 1
    Astepro Nasal Spray (0.1% azelastine hydrochloride)
    Intervention: Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
  • Active Comparator: 2
    Astelin Nasal Spray (0.1% azelastine hydrochloride)
    Intervention: Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2008)
862
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients 12 years of age and older with an established history (> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).
  2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
  3. 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.
  4. 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
  5. 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)

Exclusion Criteria:

  1. 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
  2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
  3. Women who are pregnant or nursing
  4. 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. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.
  5. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
  6. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
  7. Patients with a known history of alcohol or drug abuse
  8. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study
  9. 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
  10. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783432
Other Study ID Numbers  ICMJE MP432
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harry Sacks, MD, Vice President, Medical and Scientific Affairs
Study Sponsor  ICMJE Meda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
PRS Account Meda Pharmaceuticals
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP