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:
Meda Pharmaceuticals
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00783432
First received: October 30, 2008
Last updated: October 1, 2009
Last verified: October 2009
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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:
- 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).
- Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
- 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.
- 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
- 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:
- 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
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- Women who are pregnant or nursing
- 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.
- Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities
- Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease
- Patients with a known history of alcohol or drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study
- 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
- Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
Contacts and Locations
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 May 23, 2013