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A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01368445
First received: June 6, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: azelastine hydrochloride 0.15% Nasal Spray
Drug: azelastine hydrochloride 0.15% and Placebo
Drug: Azelastine 0.1%, Nasal Spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Patients With Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
  • Change From Baseline on Direct Visual Nasal Exams [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment: 617
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MP03-36 Nasal Spray
azelastine hydrochloride 0.15%
Drug: azelastine hydrochloride 0.15% Nasal Spray
1644 mcg, 2 sprays per nostril twice daily AM & PM)
Other Name: astepro .15%
Active Comparator: MP03-36 and Placebo Nasal Spray
azelastine hydrochloride 0.15% and Placebo
Drug: azelastine hydrochloride 0.15% and Placebo
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
Other Name: Astepro.15%
Active Comparator: Azelastine 0.1%, Nasal Spray
Azelastine 0.1%, Nasal Spray
Drug: Azelastine 0.1%, Nasal Spray
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)
Other Name: Astepro
Placebo Comparator: Placebo Nasal Sapray
0mg, 2 sprays per nostril twice daily AM & PM)
Drug: azelastine hydrochloride 0.15% Nasal Spray
1644 mcg, 2 sprays per nostril twice daily AM & PM)
Other Name: astepro .15%
Drug: azelastine hydrochloride 0.15% and Placebo
822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
Other Name: Astepro.15%
Drug: Azelastine 0.1%, Nasal Spray
1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)
Other Name: Astepro

  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
  • Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
  • Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
  • Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
  • Must have taken at least 10 doses of study medication during the lead-in period
  • Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
  • Willing and able to comply with the study requirements
  • At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
  • The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
  • 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 injections (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). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.

Exclusion Criteria:

  • The use of any investigational drug within 30 days prior to Day -7. No 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
  • Respiratory tract infections within two weeks prior to Day -7
  • Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
  • Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
  • Patients with asthma (with the exception of mild, intermittent asthma)
  • Patients with significant 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 absorption, distribution, metabolism, or excretion of study drug
  • Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
  • Planned travel outside the study area during the study period
  • Family members and employees should be excluded
  • Patients who received prohibited medications within specified timepoints in the 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: NCT01368445

  Show 30 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01368445     History of Changes
Other Study ID Numbers: MP433
Study First Received: June 6, 2011
Last Updated: October 5, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014