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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00740792
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : September 7, 2012
Last Update Posted : September 7, 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: azelastine HCl/fluticasone propionate
Drug: azelastine Hcl
Drug: fluticasone propionate
Drug: placebo
Enrollment 776
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Hide Arm/Group Description azelastine HCl/fluticasone propionate active comparator of azelastine HCl active comparator of fluticasone propionate placebo control
Period Title: Overall Study
Started 193 194 189 200
Completed 183 186 180 190
Not Completed 10 8 9 10
Reason Not Completed
Adverse Event             3             1             1             3
Lack of Efficacy             1             1             0             3
Lost to Follow-up             2             1             0             0
Protocol Violation             0             1             0             2
Withdrawal by Subject             1             1             0             0
administrative             3             3             8             2
Arm/Group Title MP29-02 Azelastine HCL Fluticasone Propionate Placebo Total
Hide Arm/Group Description azelastine HCl/fluticasone propionate active comparator of azelastine HCl active comparator of fluticasone propionate placebo control Total of all reporting groups
Overall Number of Baseline Participants 193 194 189 200 776
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 194 participants 189 participants 200 participants 776 participants
<=18 years
12
   6.2%
12
   6.2%
14
   7.4%
17
   8.5%
55
   7.1%
Between 18 and 65 years
176
  91.2%
178
  91.8%
172
  91.0%
181
  90.5%
707
  91.1%
>=65 years
5
   2.6%
4
   2.1%
3
   1.6%
2
   1.0%
14
   1.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 193 participants 194 participants 189 participants 200 participants 776 participants
38.8  (14.1) 38.2  (13.5) 37.0  (13.6) 37.2  (13.0) 37.8  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 194 participants 189 participants 200 participants 776 participants
Female
126
  65.3%
128
  66.0%
121
  64.0%
119
  59.5%
494
  63.7%
Male
67
  34.7%
66
  34.0%
68
  36.0%
81
  40.5%
282
  36.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 193 participants 194 participants 189 participants 200 participants 776 participants
193 194 189 200 776
1.Primary Outcome
Title Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)
Hide Description

change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom 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.A greater negative score is suggestive of improvement.

Time Frame day1 to 14 days
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 MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Hide Arm/Group Description:
azelastine HCl/fluticasone propionate
active comparator of azelastine HCl
active comparator of fluticasone propionate
placebo control
Overall Number of Participants Analyzed 193 194 189 200
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.5  (5.2) -4.5  (4.6) -4.6  (5.1) -3.0  (3.9)
2.Secondary Outcome
Title Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
Hide Description

change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom 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.A greater negative value is suggestive of improvement.

Time Frame day 1 to14
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 MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Hide Arm/Group Description:
azelastine HCl/fluticasone propionate
active comparator of azelastine HCl
active comparator of fluticasone propionate
placebo control
Overall Number of Participants Analyzed 193 193 188 199
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (5.3) -4.2  (4.6) -4.3  (5.2) -2.4  (4.2)
3.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Hide Description adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.
Time Frame day 1 to day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation
Arm/Group Title MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Hide Arm/Group Description:
azelastine HCl/fluticasone propionate
active comparator of azelastine HCl
active comparator of fluticasone propionate
placebo control
Overall Number of Participants Analyzed 176 172 169 171
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.7  (1.3) -1.4  (1.3) -1.5  (1.3) -1.0  (1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Hide Arm/Group Description azelastine HCl/fluticasone propionate active comparator of azelastine HCl active comparator of fluticasone propionate placebo control
All-Cause Mortality
MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/193 (0.52%)      0/194 (0.00%)      0/189 (0.00%)      0/200 (0.00%)    
Hepatobiliary disorders         
hepatitis C  1 [1]  1/193 (0.52%)  1 0/194 (0.00%)  0 0/189 (0.00%)  0 0/200 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, Medra
[1]
described by investigator as "unlikely related to study drug"
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
MP29-02 Azelastine HCL Fluticasone Propionate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/193 (12.44%)      33/194 (17.01%)      15/189 (7.94%)      13/200 (6.50%)    
Gastrointestinal disorders         
dysgeusia  1  4/193 (2.07%)  4 14/194 (7.22%)  14 1/189 (0.53%)  1 1/200 (0.50%)  1
nausea  1  1/193 (0.52%)  1 0/194 (0.00%)  0 0/189 (0.00%)  0 2/200 (1.00%)  2
General disorders         
mucosal erosion  1  3/193 (1.55%)  3 0/194 (0.00%)  0 0/189 (0.00%)  0 0/200 (0.00%)  0
Infections and infestations         
upper respiratory tract infection  1  1/193 (0.52%)  1 2/194 (1.03%)  2 1/189 (0.53%)  1 1/200 (0.50%)  1
nasopharyingitis  1  1/193 (0.52%)  1 2/194 (1.03%)  2 0/189 (0.00%)  0 0/200 (0.00%)  0
Nervous system disorders         
headache  1  6/193 (3.11%)  6 4/194 (2.06%)  4 5/189 (2.65%)  5 2/200 (1.00%)  2
Respiratory, thoracic and mediastinal disorders         
epistaxis  1  3/193 (1.55%)  3 4/194 (2.06%)  4 3/189 (1.59%)  5 5/200 (2.50%)  5
oropharyngeal pain  1  2/193 (1.04%)  2 4/194 (2.06%)  4 5/189 (2.65%)  5 2/200 (1.00%)  2
cough  1  2/193 (1.04%)  2 1/194 (0.52%)  1 0/189 (0.00%)  0 0/200 (0.00%)  0
nasal discomfort  1  1/193 (0.52%)  1 2/194 (1.03%)  2 0/189 (0.00%)  0 0/200 (0.00%)  0
Indicates events were collected by systematic assessment
1
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: NCT00740792    
Other Study ID Numbers: MP4004
First Submitted: August 22, 2008
First Posted: August 25, 2008
Results First Submitted: May 15, 2012
Results First Posted: September 7, 2012
Last Update Posted: September 7, 2012