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

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ClinicalTrials.gov Identifier: NCT00660517
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : July 23, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Seasonal Allergic Rhinitis
Interventions Drug: MP29-02
Drug: azelastine Hcl
Drug: fluticasone propionate
Drug: placebo
Enrollment 607
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Hide Arm/Group Description azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day azelastine Hcl nasal spray one spray per nostril two times a day fluticasone propionate nasal spray one spray per nostril two times a day nasal spray
Period Title: Overall Study
Started 153 152 151 151
Completed 145 144 144 144
Not Completed 8 8 7 7
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo Total
Hide Arm/Group Description azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day azelastine Hcl nasal spray one spray per nostril two times a day fluticasone propionate nasal spray one spray per nostril two times a day nasal spray Total of all reporting groups
Overall Number of Baseline Participants 153 152 151 151 607
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 151 participants 151 participants 607 participants
<=18 years
9
   5.9%
11
   7.2%
10
   6.6%
13
   8.6%
43
   7.1%
Between 18 and 65 years
136
  88.9%
132
  86.8%
137
  90.7%
131
  86.8%
536
  88.3%
>=65 years
8
   5.2%
9
   5.9%
4
   2.6%
7
   4.6%
28
   4.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 152 participants 151 participants 151 participants 607 participants
39.5  (14.2) 39.5  (14.1) 38.1  (14.2) 39.9  (14.7) 39.2  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 151 participants 151 participants 607 participants
Female
97
  63.4%
97
  63.8%
100
  66.2%
102
  67.5%
396
  65.2%
Male
56
  36.6%
55
  36.2%
51
  33.8%
49
  32.5%
211
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants 152 participants 151 participants 151 participants 607 participants
153 152 151 151 607
1.Primary Outcome
Title Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)
Hide Description change from baseline in the 12 hour reflective total nasal symptoms score(rTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.
Time Frame day 1 to day14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Hide Arm/Group Description:
azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
azelastine Hcl nasal spray one spray per nostril two times a day
fluticasone propionate nasal spray one spray per nostril two times a day
nasal spray
Overall Number of Participants Analyzed 153 152 151 151
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (5.1) -3.3  (4.2) -3.8  (4.8) -2.2  (4.2)
2.Secondary Outcome
Title Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
Hide Description

change from baseline in the 12 hour instantaneous total nasal symptoms score(iTNSS) consisting of nasal congestion,runny nose,itchy nose and sneezing scored twice daily( AM and PM) in diary cards for the entire 14 day study period.

The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.

Time Frame day 1 to day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population includes all subjects who were randomized and had at least one post baseline efficacy evaluation
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Hide Arm/Group Description:
azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
azelastine Hcl nasal spray one spray per nostril two times a day
fluticasone propionate nasal spray one spray per nostril two times a day
placebo nasal spray one spray per nostril two times a day
Overall Number of Participants Analyzed 153 152 151 150
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.4  (5.2) -3.0  (4.5) -3.5  (4.8) -1.7  (4.2)
3.Secondary Outcome
Title Change From Baseline in Adult ( Greater Than 18 Years of Age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
Hide Description Change from Baseline in adult ( greater than 18 years of age) Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the end of 14 days The measurement scale is 0 to 24. A reduction in symptom severity score is indicated by a negative value.
Time Frame day 1 to day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat(ITT) population (18 years of age or older) who have had at least one post baseline efficacy evaluation
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Hide Arm/Group Description:
azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day
azelastine Hcl nasal spray one spray per nostril two times a day
fluticasone propionate nasal spray one spray per nostril two times a day
nasal spray
Overall Number of Participants Analyzed 135 133 132 126
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (1.4) -1.2  (1.3) -1.4  (1.4) -1.0  (1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Hide Arm/Group Description azelastine Hcl/ fluticasone propionate nasal spray one spray per nostril two times a day azelastine Hcl nasal spray one spray per nostril two times a day fluticasone propionate nasal spray one spray per nostril two times a day nasal spray
All-Cause Mortality
Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/153 (0.00%)      0/152 (0.00%)      0/151 (0.00%)      0/151 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Azelastine HCl 548 Mcg / Fluticasone Propionate 200 Mcg Azelastine Hcl 548 Mcg Fluticasone Propionate 200 Mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/153 (18.30%)      15/152 (9.87%)      13/151 (8.61%)      10/151 (6.62%)    
Gastrointestinal disorders         
dysgusia  1  11/153 (7.19%)  11 3/152 (1.97%)  3 0/151 (0.00%)  0 0/151 (0.00%)  0
nausea  2  1/153 (0.65%)  1 2/152 (1.32%)  2 0/151 (0.00%)  0 2/151 (1.32%)  2
General disorders         
pharyngolaryngeal pain  2  2/153 (1.31%)  2 1/152 (0.66%)  1 0/151 (0.00%)  0 1/151 (0.66%)  1
Infections and infestations         
acute sinusitis  2  0/153 (0.00%)  0 2/152 (1.32%)  2 0/151 (0.00%)  0 0/151 (0.00%)  0
Nervous system disorders         
headache  2  4/153 (2.61%)  4 2/152 (1.32%)  2 6/151 (3.97%)  6 2/151 (1.32%)  2
Respiratory, thoracic and mediastinal disorders         
epistaxis  2  6/153 (3.92%)  6 4/152 (2.63%)  4 6/151 (3.97%)  6 5/151 (3.31%)  5
nasal discomfort  2  2/153 (1.31%)  2 0/152 (0.00%)  0 1/151 (0.66%)  1 0/151 (0.00%)  0
Skin and subcutaneous tissue disorders         
dry skin  2  2/153 (1.31%)  2 1/152 (0.66%)  1 0/151 (0.00%)  0 0/151 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, medra 10.0
2
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Investigators participating in multicenter studies must agree not to present data gathered individually or by a subgroup of centers before the full, initial publication, unless this has been agreed to by all other investigators and Meda Pharmaceuticals.

Meda Pharmaceuticals requests that it receive copies of any intended communication reasonably in advance (at least 15 working days for an abstract or oral presentation and 45 working days for a manuscript)

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Ginsberg, D.O.
Organization: Meda Pharmaceuticals
Phone: 7325642364
EMail: david.ginsberg@meda.us
Layout table for additonal information
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00660517    
Other Study ID Numbers: MP4001
First Submitted: April 14, 2008
First Posted: April 17, 2008
Results First Submitted: May 17, 2012
Results First Posted: July 23, 2012
Last Update Posted: July 27, 2012