Phase 3
N=347
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
Vasomotor Rhinitis · Rhinitis, Vasomotor
Bottom Line
View on ClinicalTrials.gov: NCT00118703 ↗Enrolled (actual)
347
Serious AEs
0.3%
Results posted
May 2017
Primary outcome: Primary: Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) — -2.11; -2.01 Score on a scale — p=0.604
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GW685698X (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) |
-2.11; -2.01 | 0.604 |
| SECONDARY Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) |
-1.65; -1.59 | 0.729 |
| SECONDARY Number of Participants Based on Overall Evaluation of Response to Therapy |
20; 28; 39; 41; 42; 43 | 0.064 |
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 vasomotor rhinitis (VMR).
Eligibility Criteria
Inclusion criteria
- Must be outpatients.
- Diagnosis of VMR (vasomotor rhinitis).
- Literate in English or native language.
Exclusion criteria
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Used tobacco products within the past year.
Data sourced from ClinicalTrials.gov (NCT00118703). 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.