Phase 3 N=352 Randomized Treatment

Study Of Adults And Adolescents With Vasomotor Rhinitis

Rhinitis, Vasomotor

Bottom Line

View on ClinicalTrials.gov: NCT00117325 ↗

Enrolled (actual)

352

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) — -1.71; -2.05 Score on scale — p=0.050

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 Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)	-1.71; -2.05	0.050
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)	-1.48; -1.87	0.027 sig
SECONDARY Number of Participants With Overall Evaluation of Response to Therapy	26; 33; 37; 40; 45; 47	0.184
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS	-1.69; -2.04	0.051
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS	-1.77; -2.07	0.076
SECONDARY Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS	-26.14; -30.65	0.093
SECONDARY Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS	-21.09; -27.46	0.023 sig
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip	-0.50; -0.62; -0.68; -0.81; -0.51; -0.61	0.061
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	-0.44; -0.56; -0.54; -0.70; -0.48; -0.60	0.087
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	-0.48; -0.61; -0.65; -0.78; -0.55; -0.64	0.048 sig
SECONDARY Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	-0.53; -0.59; -0.73; -0.84; -0.49; -0.59	0.136
SECONDARY Mean Scores Changes From Baseline as a Function of Time	-0.47; -0.92; -0.69; -1.01; -0.75; -1.14	0.011 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 vasomotor rhinitis (VMR).

Eligibility Criteria

Inclusion criteria

Must be outpatients.
Diagnosis of VMR.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00117325). 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.