Perennial Allergic Rhinitis
Conditions
Brief summary
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
Interventions
DRUGGSP 301 NS
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
DRUGGSP 301 Placebo NS pH 3.7
2 spray in each nostril twice daily for 52 weeks
DRUGGSP 301 Placebo NS pH 7.0
2 spray in each nostril twice daily for 52 weeks
Sponsors
Glenmark Specialty S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥12 years and older inclusive of either sex. 2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.
Exclusion criteria
1. Pregnant or lactating women. 2. History of anaphylaxis and/or other severe local reaction(s) to skin testing. 3. History of positive test for HIV, Hepatitis B or Hepatitis C infection. 4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 5. Subjects with an active pulmonary disorder or infection. 6. Subjects with posterior subcapsular cataracts or glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs). | 52 weeks | All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GSP 301 NS GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks | 393 |
| GSP 301 Placebo NS pH 3.7 GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks | 99 |
| GSP 301 Placebo NS pH 7.0 GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks | 101 |
| Total | 593 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 13 | 2 | 3 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 24 | 8 | 4 |
| Overall Study | Non-compliance with study drug | 2 | 0 | 0 |
| Overall Study | Non-compliance with study procedures | 5 | 0 | 0 |
| Overall Study | Other | 16 | 7 | 5 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Protocol deviation | 10 | 4 | 4 |
| Overall Study | Withdrawal by Parent or Legal Guardian | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 40 | 7 | 4 |
Baseline characteristics
| Characteristic | GSP 301 NS | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 7.0 | Total |
|---|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 14.8 | 42.1 years STANDARD_DEVIATION 15.4 | 41.2 years STANDARD_DEVIATION 13.5 | 40.8 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 1 Participants | 2 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 95 Participants | 17 Participants | 22 Participants | 134 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 282 Participants | 78 Participants | 76 Participants | 436 Participants |
| Sex: Female, Male Female | 269 Participants | 68 Participants | 68 Participants | 405 Participants |
| Sex: Female, Male Male | 124 Participants | 31 Participants | 33 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 393 | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 72 / 393 | 15 / 99 | 25 / 101 |
| serious Total, serious adverse events | 7 / 393 | 2 / 99 | 2 / 101 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Time frame: 52 weeks
Population: Safety Analysis Set (SAS) will consist of all subjects who took at least 1 dose of study medication following randomization. This was the primary analysis set for safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSP 301 NS | Number of Participants With Treatment-emergent Adverse Events (TEAEs). | 203 participants |
| GSP 301 Placebo NS pH 3.7 | Number of Participants With Treatment-emergent Adverse Events (TEAEs). | 41 participants |
| GSP 301 Placebo NS pH 7.0 | Number of Participants With Treatment-emergent Adverse Events (TEAEs). | 54 participants |