A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
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| ClinicalTrials.gov Identifier: NCT00719862 |
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Recruitment Status :
Completed
First Posted : July 22, 2008
Results First Posted : January 28, 2010
Last Update Posted : February 2, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Seasonal Allergic Rhinitis | Drug: Placebo nasal spray Drug: 0.15% azelastine hydrochloride Nasal Spray | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 481 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | November 2007 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo Nasal Spray
0mg Placebo Nasal Spray
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Drug: Placebo nasal spray
Placebo |
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Active Comparator: 0.15% azelastine hydrochloride nasal spray
0.15% azelastine hydrochloride
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Drug: 0.15% azelastine hydrochloride Nasal Spray
0.15% azelastine hydrochloride 822 mcg
Other Name: astepro 0.15% |
- Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14 days ]
reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
- Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo [ Time Frame: baseline and 14 days ]
End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
- Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days [ Time Frame: baseline and 14-days ]
instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
- Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined) [ Time Frame: baseline and 14-days ]
Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
- Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days [ Time Frame: baseline and 14 Days ]
A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
- Change From Baseline on Direct Visual Nasal Exams at 14 Days [ Time Frame: baseline and 14 days ]Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in the protocol
- Must be willing and able to provide informed consent and to participate in all study procedures
- Positive skin test to a prevalent fall allergen
Exclusion Criteria:
- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
- Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- Nasal Surgery or sinus surgery within the previous year
- Chronic sinusitis-more than 3 episodes a year
- Planned travel outside of the study area during the study period
- The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
- Respiratory tract infection within 14 days prior to screening
- Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
- Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
- Significant pulmonary disease including COPD
- Clinically significant arrythmia or symptomatic cardiac conditions
- A known history of alcohol or drug abuse within the last 2 years
- Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
- Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719862
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| Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
| Responsible Party: | Harry Sacks, MD Vice President, Medical and Scientific Affairs |
| ClinicalTrials.gov Identifier: | NCT00719862 |
| Other Study ID Numbers: |
MP439 |
| First Posted: | July 22, 2008 Key Record Dates |
| Results First Posted: | January 28, 2010 |
| Last Update Posted: | February 2, 2010 |
| Last Verified: | January 2010 |
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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Azelastine Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Lipoxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |