A Phase 4 interventional study of Budesonide and Placebo in Rhinitis, sponsored by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Completed at 6 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Phase 4, Interventional, and Treatment
The primary objective of this study is to assess the effectiveness of intranasal budesonide aqueous spray 256 microgram (mcg)/day for treatment of rhinitis symptoms during times of high airborne pollution.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 206 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will self-administer 2 nasal sprays of Budesonide (64 microgram \[mcg\]/spray) in each nostril once daily (every morning) up to 10 +\\- 3 Days.
Drug: Budesonide
Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\\- 3 Days.
Other: Placebo
Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\\- 3 Days.
Also known as: RHINOCORT
Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\\- 3 Days.
Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)
Mean change from baseline in 24-hour reflective total nasal symptom score (rTNSS) calculated as the sum of the participant-assessed 24-hour reflective severity ratings for three individual nasal symptom scores (nasal obstruction, secretion/runny nose, itching/sneezing) averaged over the first 10-day treatment period. Baseline value will be a single 24-hour rTNSS recorded on the no-treatment evening following the baseline visit. The individual nasal symptom scores will be recorded at home by participants in their diary on a four point scale (from 0=none to 3=severe). The sum of the individual scores will form the 24-hour rTNSS.
Time frame: Baseline up to 10 days (24 hours each day)
Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment
Participant will rate Global Impression of Change at Final Efficacy Assessment on a 5-point scale from 0 (symptoms were aggravated) to 4 (total control over symptoms). An increase in score indicates the improvement in condition.
Time frame: Day 10 (+/-3)
Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS)
Mean Change from Baseline in individual NSS for nasal obstruction, secretion/runny nose, and itching/sneezing averaged over the first 10-day treatment period will be reported using 4-point scale from 0=None, 1=Mild, 2=Moderate, or 3=Severe.
Time frame: Baseline to 10 days (24 hours each day)
Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip)
Mean Change from Baseline in 24-hour reflective Individual non-Nasal Symptoms Score for cough and post-nasal drip averaged over the first 10-day treatment period, using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe condition.
Time frame: Baseline to 10 days (24 hours each day)
Number of Participants With Adverse Events (AEs) as a Measure of Safety
An AE is any untoward medical occurrence in a clinical study subject administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Time frame: Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10)
Plan to share: Yes — Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division