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
  Purpose

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)


Condition Intervention Phase
Chronic Allergic Rhinitis
Nonallergic Rhinitis
Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 862
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Astepro Nasal Spray (0.1% azelastine hydrochloride)
Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
548 mcg (2 sprays per nostril) twice a day
Active Comparator: 2
Astelin Nasal Spray (0.1% azelastine hydrochloride)
Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)
548 mcg (2 sprays per nostril) twice a day

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783432

Locations
United States, New Jersey
Meda Clinical Trials Contact Center
Somerset, New Jersey, United States, 08873
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Harry Sacks, MD, Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier: NCT00783432     History of Changes
Other Study ID Numbers: MP432
Study First Received: October 30, 2008
Results First Received: December 29, 2008
Last Updated: October 1, 2009
Health Authority: Bulgaria: Ministry of Health
Slovakia: State Institute for Drug Control
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Azelastine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014