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Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR

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ClinicalTrials.gov Identifier: NCT01880840
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
Novella Clinical
Information provided by (Responsible Party):
Meda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Allergic Rhinitis
Interventions Drug: 205.5 mcg of azelastine hydrochloride
Drug: 137 mcg of azelastine hydrochloride
Enrollment 191
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Astepro 0.15% Astepro 0.1%
Hide Arm/Group Description azelastine hydrochloride 822mcg nasal spray azelastine hydrochloride 548 mcg nasal spray
Period Title: Overall Study
Started 95 96
Completed 87 91
Not Completed 8 5
Arm/Group Title Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray Total
Hide Arm/Group Description

Nasal Spray at a dosage of 1 spray per nostril twice daily

205.5 mcg of azelastine hydrochloride: nasal spray

Nasal Spray at a dosage of 1 spray per nostril twice daily

137 mcg of azelastine hydrochloride: nasal spray

Total of all reporting groups
Overall Number of Baseline Participants 95 96 191
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 96 participants 191 participants
<=18 years
95
 100.0%
96
 100.0%
191
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 96 participants 191 participants
3.29  (1.538) 3.37  (1.595) 3.33  (1.566)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 96 participants 191 participants
Female
36
  37.9%
45
  46.9%
81
  42.4%
Male
59
  62.1%
51
  53.1%
110
  57.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants 96 participants 191 participants
95 96 191
1.Primary Outcome
Title Safety
Hide Description

The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to <6 years of age with allergic rhinitis.

Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments.

Data for each age strata will be summarized separately as well as combined.

Time Frame one month of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray
Hide Arm/Group Description:

Nasal Spray at a dosage of 1 spray per nostril twice daily

205.5 mcg of azelastine hydrochloride: nasal spray

Nasal Spray at a dosage of 1 spray per nostril twice daily

137 mcg of azelastine hydrochloride: nasal spray

Overall Number of Participants Analyzed 95 96
Measure Type: Number
Unit of Measure: adverse events
43 39
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray
Hide Arm/Group Description

Nasal Spray at a dosage of 1 spray per nostril twice daily

205.5 mcg of azelastine hydrochloride: nasal spray

Nasal Spray at a dosage of 1 spray per nostril twice daily

137 mcg of azelastine hydrochloride: nasal spray

All-Cause Mortality
Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/95 (1.05%)      0/96 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
exacerbation of asthma  [1]  1/95 (1.05%)  1 0/96 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
recovered/resolved
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Astepro 0.15% Nasal Spray Astepro 0.1% Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/95 (24.21%)      15/96 (15.63%)    
Ear and labyrinth disorders     
otitis media   0/95 (0.00%)  3/96 (3.13%) 
Gastrointestinal disorders     
dysgusia   2/95 (2.11%)  0/96 (0.00%) 
vomiting   2/95 (2.11%)  1/96 (1.04%) 
General disorders     
pyrexia   6/95 (6.32%)  5/96 (5.21%) 
oropharyngial pain   0/95 (0.00%)  2/96 (2.08%) 
Infections and infestations     
upper respiratory tract infection   2/95 (2.11%)  1/96 (1.04%) 
Respiratory, thoracic and mediastinal disorders     
cough   3/95 (3.16%)  1/96 (1.04%) 
epistaxis   3/95 (3.16%)  0/96 (0.00%) 
sneezing   3/95 (3.16%)  0/96 (0.00%) 
rhinalgia   2/95 (2.11%)  0/96 (0.00%) 
Skin and subcutaneous tissue disorders     
dermatitis,contact   0/95 (0.00%)  2/96 (2.08%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr.Nancy Ruiz Chief Medical Officer
Organization: Meda Pharmaceutical
Phone: 732 564 2200 ext 2390
Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01880840     History of Changes
Other Study ID Numbers: MP 442
First Submitted: June 17, 2013
First Posted: June 19, 2013
Results First Submitted: June 9, 2015
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015