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:
Meda Pharmaceuticals
Information provided by:
Meda Pharmaceuticals
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
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 |
---|---|---|
![]() |
(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
|
Baseline Characteristics
Arm/Group Title | Astepro Nasal Spray | Astelin Nasal Spray | Total | |
---|---|---|---|---|
![]() |
(0.1% azelastine hydrochloride) | (0.1% azelastine hydrochloride) | Total of all reporting groups | |
Overall Number of Baseline Participants | 428 | 430 | 858 | |
![]() |
[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.
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
EMail: | wwheeler@medapharma.us |
Responsible Party: | Harry Sacks, MD, Vice President, Medical and Scientific Affairs |
ClinicalTrials.gov Identifier: | NCT00783432 |
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 |