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

Last updated: October 1, 2009
Sponsor: Meda Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Common Cold

Acute Rhinitis

Allergy

Treatment

N/A

Clinical Study ID

NCT00783432
MP432
  • Ages > 12
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female patients 12 years of age and older with an established history (> 1year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotorrhinitis (VMR).

  2. Provide written informed consent/pediatric assent. If the patient is a minor, a parentor legal guardian must give written informed consent

  3. Willing and able to comply with the study requirements, including daily use ofmedication for a one year period, even if symptoms are not bothersome.

  4. General good health and free of any disease or concomitant treatment that couldinterfere with the interpretation of the study results as determined by theinvestigator or the sponsor's medical officer

  5. Patients receiving immunotherapy (antigen desensitization) must be on a stablemaintenance regimen for at least 30 days before the first study visit (adjustments toregimen following a brief period of missed injections does not preclude participation)

Exclusion

Exclusion Criteria:

  1. The use of any investigational drug within 30 days prior to screening. No otherinvestigational products are permitted for use during the conduct of this study

  2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitolor sucralose (Splenda® brand sweetener)

  3. Women who are pregnant or nursing

  4. Women of childbearing potential who are not abstinent and not practicing a medicallyacceptable method of contraception. Female patients must practice an acceptablecontraceptive technique for 30 days before randomization and agree to continue its useduring treatment and for 30 days after the last dose of study drug. Oral,intrauterine, implantable, injectable contraceptives, or a double barrier form ofcontraception are acceptable and the medication including dose, device or method musthave 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 assinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasalstructural abnormalities

  6. Patients with asthma (with the exception of mild, intermittent asthma) or othersignificant 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 theinvestigator or sponsor, might significantly alter the evaluation of study

  9. Clinically relevant abnormal history and/or physical findings which, in the opinion ofthe investigator or sponsor, would interfere with the objectives of the study or thatmay preclude compliance with the study procedures

  10. Study site staff, immediate relatives of study site staff, or other individuals whowould have access to the clinical study protocol

Study Design

Total Participants: 862
Study Start date:
July 01, 2006
Estimated Completion Date:
December 31, 2007

Connect with a study center

  • Meda Clinical Trials Contact Center

    Somerset, New Jersey 08873
    United States

    Site Not Available

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