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

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00783432
First received: October 30, 2008
Last updated: October 1, 2009
Last verified: October 2009

October 30, 2008
October 1, 2009
July 2006
December 2007   (final data collection date for primary outcome measure)
  • Number of Participants Reporting Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. [ Time Frame: baseline and 12 months/ET ] [ Designated as safety issue: Yes ]
  • Frequency of patient-reported adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Direct visual examination with specific attention to evidence of nasal irritation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00783432 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Allergic Rhinitis
  • Nonallergic Rhinitis
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
862
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783432
MP432
No
Harry Sacks, MD, Vice President, Medical and Scientific Affairs
Meda Pharmaceuticals
Not Provided
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
Meda Pharmaceuticals
October 2009

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