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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: NCT00651118
Recruitment Status : Completed
First Posted : April 2, 2008
Results First Posted : September 26, 2012
Last Update Posted : September 26, 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: Placebo
Drug: azelastine Hcl
Drug: azelastineHcl / fluticasone propionate
Drug: fluticasone propionate
Enrollment 832
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Hide Arm/Group Description MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray fluticasone propionate nasal spray azelastine HCl nasal spray nasal spray placebo nasal spray
Period Title: Overall Study
Started 207 207 208 210
Completed 198 200 197 203
Not Completed 9 7 11 7
Reason Not Completed
Adverse Event             4             0             1             1
Protocol Violation             2             2             6             2
Lost to Follow-up             2             0             1             2
administrative             1             4             2             1
Withdrawal by Subject             0             1             1             1
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo Total
Hide Arm/Group Description MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray fluticasone propionate nasal spray azelastine HCl nasal spray nasal spray placebo nasal spray Total of all reporting groups
Overall Number of Baseline Participants 207 207 208 210 832
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 208 participants 210 participants 832 participants
<=18 years
19
   9.2%
15
   7.2%
28
  13.5%
36
  17.1%
98
  11.8%
Between 18 and 65 years
183
  88.4%
185
  89.4%
172
  82.7%
166
  79.0%
706
  84.9%
>=65 years
5
   2.4%
7
   3.4%
8
   3.8%
8
   3.8%
28
   3.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 207 participants 208 participants 210 participants 832 participants
37.3  (14.1) 38.6  (14.1) 36.2  (14.6) 37.3  (16.0) 37.3  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 207 participants 208 participants 210 participants 832 participants
Female
142
  68.6%
127
  61.4%
130
  62.5%
133
  63.3%
532
  63.9%
Male
65
  31.4%
80
  38.6%
78
  37.5%
77
  36.7%
300
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 207 participants 207 participants 208 participants 210 participants 832 participants
207 207 208 210 832
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 did you feel in the last 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.The more negative value the better the result.

Time Frame days 1 to 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat population (ITT)- must have had at least one post baseline efficacy assessment
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Hide Arm/Group Description:
MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
fluticasone propionate nasal spray
azelastine HCl nasal spray nasal spray
placebo nasal spray
Overall Number of Participants Analyzed 207 207 208 209
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.6  (5.2) -4.7  (4.7) -4.2  (4.6) -2.9  (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.The more negative the value the better the result.

Time Frame day 1 to day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat population (ITT)- must have had at least one post baseline efficacy assessment
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Hide Arm/Group Description:
fluticasone propionate 50 mcg / azelastine HCl 137 mcg nasal spray
fluticasone propionate nasal spray
azelastine HCl nasal spray
Placebo nasal spray
Overall Number of Participants Analyzed 207 207 208 209
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (5.3) -4.5  (4.7) -4.0  (4.7) -2.6  (4.1)
3.Secondary Outcome
Title Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
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.The more negative the value the better the result.

Time Frame day 1 to day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat( ITT)population (18 yrs of age or older) must have had at least one post baseline efficacy assessment
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Hide Arm/Group Description:
MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray
fluticasone propionate nasal spray
azelastine HCl nasal spray nasal spray
placebo nasal spray
Overall Number of Participants Analyzed 176 184 174 169
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (1.4) -1.6  (1.2) -1.4  (1.1) -0.9  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Hide Arm/Group Description MP29-02(fluticasone propionate 50 mcg / azelastine HCl 137 mcg) nasal spray fluticasone propionate nasal spray azelastine HCl nasal spray nasal spray placebo nasal spray
All-Cause Mortality
MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/207 (0.00%)      0/207 (0.00%)      0/208 (0.00%)      0/210 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
MP29-02 Fluticasone Propionate Azelastine HCl Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/207 (5.80%)      16/207 (7.73%)      19/208 (9.13%)      7/210 (3.33%)    
Gastrointestinal disorders         
dysgusia * 1  5/207 (2.42%)  5 2/207 (0.97%)  2 7/208 (3.37%)  7 1/210 (0.48%)  1
nausea * 2  1/207 (0.48%)  1 2/207 (0.97%)  2 1/208 (0.48%)  1 0/210 (0.00%)  0
Nervous system disorders         
headache * 2  1/207 (0.48%)  1 5/207 (2.42%)  5 1/208 (0.48%)  1 3/210 (1.43%)  3
Respiratory, thoracic and mediastinal disorders         
epistaxis * 2  2/207 (0.97%)  2 5/207 (2.42%)  5 4/208 (1.92%)  4 2/210 (0.95%)  2
nasal discomfort * 2  2/207 (0.97%)  2 2/207 (0.97%)  2 4/208 (1.92%)  4 0/210 (0.00%)  0
sneezing * 2  1/207 (0.48%)  1 0/207 (0.00%)  0 2/208 (0.96%)  2 1/210 (0.48%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: David Ginsberg,..
Organization: Meda Pharmaceutical
Phone: 732 564 2364
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00651118     History of Changes
Other Study ID Numbers: MP4002
First Submitted: March 28, 2008
First Posted: April 2, 2008
Results First Submitted: May 10, 2012
Results First Posted: September 26, 2012
Last Update Posted: September 26, 2012