Phase 3
N=302
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT00289198 ↗Enrolled (actual)
302
Serious AEs
0.3%
Results posted
Apr 2018
Primary outcome: Primary: Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks — -2.69; -3.95 Scores on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FF (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks |
-2.69; -3.95 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period |
-2.36; -3.82 | <0.001 sig |
| SECONDARY Number of Participants With Response to Therapy Over Entire Treatment Period |
21; 56; 38; 37; 37; 31 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period |
-2.66; -3.93 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period |
-2.73; -4.02 | <0.001 sig |
| SECONDARY Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period |
-30.23; -44.35 | <0.001 sig |
| SECONDARY Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period |
-24.67; -44.70 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period |
-0.67; -0.94; -0.69; -0.97; -0.65; -0.98 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period |
-0.57; -0.93; -0.55; -0.92; -0.61; -0.98 | 0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment |
-0.67; -0.95; -0.66; -0.98; -0.64; -0.96 | 0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period |
-0.66; -0.96; -0.70; -0.97; -0.68; -1.01 | <0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period |
-1.41; -1.92 | 0.004 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period |
-1.26; -1.76 | 0.007 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period |
-1.39; -1.92 | 0.003 sig |
| SECONDARY Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period |
-1.44; -1.93 | 0.005 sig |
| SECONDARY Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period |
-0.47; -0.69; -0.48; -0.62; -0.45; -0.61 | 0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period |
-0.39; -0.6; -0.43; -0.59; -0.45; -0.56 | 0.002 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period |
-0.48; -0.69; -0.48; -0.62; -0.44; -0.61 | 0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period |
-0.47; -0.69; -0.49; -0.62; -0.47; -0.61 | 0.001 sig |
| SECONDARY Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period |
17.35; 25.72 | 0.004 sig |
| SECONDARY Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period |
16.33; 25.61 | 0.002 sig |
| SECONDARY Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period |
18.51; 26.15 | 0.009 sig |
Summary
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
Exclusion Criteria
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy and other identified medications during the study.
- Current tobacco use or tobacco use within the past year.
- Exposure to an investigational study drug within the past 12 months.
- Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Data sourced from ClinicalTrials.gov (NCT00289198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.