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Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

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: NCT00783432
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : October 2, 2009
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:
Meda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Allergic Rhinitis
Nonallergic Rhinitis
Interventions Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)
Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)
Enrollment 862
Recruitment Details First observation 24 July 2006 and last observation 28 Dec 2007
Pre-assignment Details Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray
Hide Arm/Group Description (0.1% azelastine hydrochloride) (0.1% azelastine hydrochloride)
Period Title: Overall Study
Started 430 [1] 432 [1]
Completed 345 354
Not Completed 85 78
Reason Not Completed
Adverse Event             22             17
Lack of Efficacy             20             21
Lost to Follow-up             11             6
Withdrawal by Subject             23             20
subject moved             3             5
Protocol Violation             6             9
[1]
This includes 2 subjects that received a randomization number but did not receive study drug
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray Total
Hide Arm/Group Description (0.1% azelastine hydrochloride) (0.1% azelastine hydrochloride) Total of all reporting groups
Overall Number of Baseline Participants 428 430 858
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 430 participants 858 participants
<=18 years
11
   2.6%
10
   2.3%
21
   2.4%
Between 18 and 65 years
389
  90.9%
391
  90.9%
780
  90.9%
>=65 years
28
   6.5%
29
   6.7%
57
   6.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 428 participants 430 participants 858 participants
41.2  (14.95) 41.3  (15.12) 41.2  (15.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 430 participants 858 participants
Female
221
  51.6%
236
  54.9%
457
  53.3%
Male
207
  48.4%
194
  45.1%
401
  46.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 430 participants 858 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
   1.9%
16
   3.7%
24
   2.8%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
1
   0.1%
Black or African American
6
   1.4%
4
   0.9%
10
   1.2%
White
410
  95.8%
405
  94.2%
815
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   0.7%
5
   1.2%
8
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 428 participants 430 participants 858 participants
Australia 40 39 79
Europe 388 391 779
Duration of Rhinitis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 428 participants 430 participants 858 participants
10.5  (11.04) 11.3  (10.85) 10.9  (10.95)
Total Nasal Symptom Score (AM + PM)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale (0-3)
Number Analyzed 428 participants 430 participants 858 participants
9.69  (4.506) 9.96  (4.725) 9.82  (4.617)
[1]
Measure Description: TNSS scale: 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3 = severe symptoms scored twice daily such that the maximum daily score is 24.
1.Primary Outcome
Title Number of Participants Reporting Adverse Events
Hide Description An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray
Hide Arm/Group Description:
(0.1% azelastine hydrochloride)
(0.1% azelastine hydrochloride)
Overall Number of Participants Analyzed 428 430
Measure Type: Number
Unit of Measure: Participants
207 211
2.Primary Outcome
Title Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
Hide Description Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.
Time Frame baseline and 12 months/ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray
Hide Arm/Group Description:
(0.1% azelastine hydrochloride)
(0.1% azelastine hydrochloride)
Overall Number of Participants Analyzed 428 430
Measure Type: Number
Unit of Measure: Participants
Conjunctiva: Total baseline 428 430
Conjunctiva: baseline-None 264 254
Conjunctiva: baseline-Mild (1+) 99 109
Conjunctiva: baseline-Moderate (2+) 53 54
Conjunctiva: baseline-Severe (3+) 12 13
Conjunctiva: Total M12/ET 414 417
Conjunctiva: M12/ET-None 366 363
Conjunctiva: M12/ET-Mild (1+) 44 43
Conjunctiva: M12/ET-Moderate (2+) 4 11
Conjunctiva:M12/ET-Severe (3+) 0 0
Tympanic membranes: Total baseline 428 430
Tympanic membranes: baseline-None 342 344
Tympanic membranes: baseline-Mild (1+) 60 62
Tympanic membranes:baselineModerate (2+) 21 17
Tympanic membranes: baseline-Severe (3+) 5 7
Tympanic membranes: Total M12/ET 414 417
Tympanic membranes: M12/ET-None 405 408
Tympanic membranes:M12/ET-Mild (1+) 8 5
Tympanic membranes: M12/ET-Moderate (2+) 1 4
Tympanic membranes:M12/ET Severe (3+) 0 0
Lymphadenopathy: Total baseline 428 430
Lymphadenopathy: baseline-None 389 393
Lymphadenopathy: baseline-Mild (1+) 32 27
Lymphadenopathy: baseline-Moderate (2+) 7 7
Lymphadenopathy: baseline-Severe (3+) 0 3
Lymphadenopathy: Total M12/ET 414 417
Lymphadenopathy: M12/ET-None 408 407
Lymphadenopathy:M12/ET-Mild (1+) 6 10
Lymphadenopathy:M12/ET-Moderate (2+) 0 0
Lymphadenopathy: M12/ET-Severe (3+) 0 0
Mucosal edema: Total baseline 428 430
Mucosal edema: baseline-None 32 30
Mucosal edema: baseline-Mild (1+) 91 80
Mucosal edema: baseline-Moderate (2+) 191 200
Mucosal edema: baseline-Severe (3+) 114 120
Mucosal edema: Total M12/ET 414 417
Mucosal edema:M12/ET-None 160 147
Mucosal edema: M12/ET-Mild (1+) 176 182
Mucosal edema: M12/ET-Moderate (2+) 69 76
Mucosal edema: M12/ET-Severe (3+) 9 12
Nasal discharge: Total baseline 428 430
Nasal discharge: baseline-None 40 44
Nasal discharge: baseline-Mild (1+) 113 109
Nasal discharge: baseline-Moderate (2+) 179 183
Nasal discharge: baseline-Severe (3+) 96 94
Nasal discharge: Total M12/ET 414 417
Nasal discharge:M12/ET-None 178 173
Nasal discharge: M12/ET-Mild (1+) 188 183
Nasal discharge: M12/ET-Moderate (2+) 46 54
Nasal discharge:M12/ET-Severe (3+) 2 7
Mucosal erythema: Total baseline 428 430
Mucosal erythema: baseline-None 80 82
Mucosal erythema: baseline-Mild (1+) 120 112
Mucosal erythema: baseline-Monderate (2+) 171 178
Mucosal erythema: baseline-Severe (3+) 57 58
Mucosal erythema: Total M12/ET 414 417
Mucosal erythema: M12/ET-None 213 221
Mucosal erythema: M12/ET-Mild (1+) 152 153
Mucosal erythema: M12/ET-Moderate (2+) 45 35
Mucosal erythema:M12/ET-Severe (3+) 4 8
Mucosal bleeding: Total baseline 428 430
Mucosal bleeding: baseline-None 362 376
Mucosal bleeding: baseline-Mild (1+) 56 51
Mucosal bleeding: baseline-Moderate (2+) 10 2
Mucosal bleeding: baseline-Severe (3+) 0 1
Mucosal bleeding: Total M12/ET 414 417
Mucosal bleeding: M12/ET-None 402 403
Mucosal bleeding: M12/ET-Mild (1+) 11 10
Mucosal bleeding: M12/ET-Moderate (2+) 1 4
Mucosal bleeding: M12/ET-Severe (3+) 0 0
Mucosal ulcerations: Total baseline 428 430
Mucosal ulcerations: baseline-None 348 362
Mucosal ulcerations: baseline-Mild (1+) 48 37
Mucosal ulcerations: baseline-Moderate (2+) 26 25
Mucosal ulcerations: baseline-Severe (3+) 6 6
Mucosal ulcerations: Total M12/ET 414 417
Mucosal ulcerations: M12/ET-None 401 404
Mucosal ulcerations: M12/ET-Mild (1+) 11 10
Mucosal ulcerations: M12/ET-Moderate (2+) 2 3
Mucosal ulcerations: M12/ET-Severe (3+) 0 0
Crusting of mucosa: Total baseline 428 430
Crusting of mucosa: baseline-None 293 311
Crusting of mucosa: baseline-Mild (1+) 86 75
Crusting of mucosa: baseline-Moderate (2+) 36 35
Crusting of mucosa: baseline-Severe (3+) 13 9
Crusting of mucosa: Total M12/ET 414 417
Crusting of mucosa: M12/ET-None 387 382
Crusting of mucosa: M12/ET-Mild (1+) 24 32
Crusting of mucosa: M12/ET-Moderate (2+) 3 3
Crusting of mucosa:M12/ET-Severe (3+) 0 0
Epistaxis: Total baseline 428 430
Epistaxis: baseline None 402 416
Epistaxis: baseline Grade 2 26 12
Epistaxis: baseline Grade 3 0 1
Epistaxis: baseline Grade 4 0 1
Epistaxis:Total M12/ET 414 417
Epistaxis: M12/ET None 413 415
Epistaxis: M12/ETGrade 2 1 2
Epistaxis:M12/ET Grade 3 0 0
Epistaxis: M12/ETGrade 4 0 0
Ulceration: Total baseline 428 430
Ulceration: baseline None 365 373
Ulceration: baseline Grade 2 63 57
Ulceration: baseline Grade 3 0 0
Ulceration: baseline Grade 4 0 0
Ulceration: Total M12/ET 413 417
Ulceration:M12/ET None 404 411
Ulceration: M12/ET Grade 2 8 6
Ulceration: M12/ET Grade 3 1 0
Ulceration: M12/ET Grade 4 0 0
Pain: Total baseline 428 430
Pain: baseline None 377 382
Pain: baseline Grade 2 38 28
Pain: baseline Grade 3 6 17
Pain: baseline Grade 4 7 3
Pain: Total M12/ET 413 417
Pain: M12/ET None 401 409
Pain: M12/ET Grade 2 10 6
Pain: M12/ET Grade 3 2 2
Pain: M12/ET Grade 4 0 0
3.Secondary Outcome
Title Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.
Hide Description 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. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.
Time Frame baseline, months 1,3,6,9 and 12/or early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray
Hide Arm/Group Description:
(0.1% azelastine hydrochloride)
(0.1% azelastine hydrochloride)
Overall Number of Participants Analyzed 428 430
Least Squares Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.25  (1.103) 2.18  (1.050)
Month 1 -0.77  (1.007) -0.83  (0.959)
Month 3 -1.00  (1.063) -1.00  (1.048)
Month 6 -1.04  (1.206) -0.94  (1.230)
Month 9 -1.09  (1.228) -1.16  (1.197)
Month 12/Early termination -0.88  (1.385) -0.90  (1.339)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments This is the Baseline P-Value
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.327
Comments This P-Value if for Month 1
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.991
Comments This P-Value is for Month 3
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.168
Comments This P-Value is for Month 6
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments This P-Value is for Month 9
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Astepro Nasal Spray, Astelin Nasal Spray
Comments Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments This P-Value is for Month 12/ET
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Astepro Nasal Spray Astelin Nasal Spray
Hide Arm/Group Description (0.1% azelastine hydrochloride) (0.1% azelastine hydrochloride)
All-Cause Mortality
Astepro Nasal Spray Astelin Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Astepro Nasal Spray Astelin Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7      10    
Cardiac disorders     
Battery change for internal cardiac defibrillator  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Exacerbation angina pectoris  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Central Chest Pain  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Gastrointestinal disorders     
Upper Abdominal Colic  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Infections and infestations     
Sialoadenitis  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Acute Pyelonephritis  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Pneumonia Chlamidalis  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Injury, poisoning and procedural complications     
Knee traumatism  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Fracture left foot  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Broken nose  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Musculoskeletal and connective tissue disorders     
Exacerbation right shoulder pain  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Total right hip replacement  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal Carcinoma  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Basal Cell Carcinoma  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Prostate cancer  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Nervous system disorders     
Syncope  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Pregnancy, puerperium and perinatal conditions     
Spontaneous Abortion  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Renal and urinary disorders     
Removal of bladder stones  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Reproductive system and breast disorders     
Ovarian Cyst  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/428 (0.23%)  1 0/430 (0.00%)  0
Exertional dyspnoea  1  0/428 (0.00%)  0 1/430 (0.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Astepro Nasal Spray Astelin Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   163      146    
Infections and infestations     
Nasopharyngitis *  34/428 (7.94%)  34 25/430 (5.81%)  25
Nervous system disorders     
Headache *  49/428 (11.45%)  49 43/430 (10.00%)  43
Dysgeusia *  28/428 (6.54%)  28 32/430 (7.44%)  32
Respiratory, thoracic and mediastinal disorders     
Epistaxis *  29/428 (6.78%)  29 32/430 (7.44%)  32
Pharyngolaryngeal Pain *  23/428 (5.37%)  23 14/430 (3.26%)  14
*
Indicates events were collected by non-systematic assessment
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.
For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the Sponsor. Authorship will be determined by mutual agreement.
Results Point of Contact
Name/Title: William Wheeler, PhD
Organization: Meda Pharmaceuticals
Phone: 732-564-2351
Responsible Party: Harry Sacks, MD, Vice President, Medical and Scientific Affairs
ClinicalTrials.gov Identifier: NCT00783432     History of Changes
Other Study ID Numbers: MP432
First Submitted: October 30, 2008
First Posted: October 31, 2008
Results First Submitted: December 29, 2008
Results First Posted: October 2, 2009
Last Update Posted: October 6, 2009