A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
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|ClinicalTrials.gov Identifier: NCT04132570|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis||Drug: Budesonide Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind|
|Official Title:||A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||March 13, 2020|
|Estimated Study Completion Date :||September 28, 2020|
Experimental: Budesonide 256 mcg per Day (Treatment A)
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.
Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\- 3 Days.
Other Name: RHINOCORT
Placebo Comparator: Placebo (Treatment B)
Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days.
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) [ Time Frame: Baseline up to 10 days (24 hours each day) ]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.
- Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment [ Time Frame: Day 10 (+/-3) ]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.
- Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS) [ Time Frame: Baseline to 10 days (24 hours each day) ]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.
- Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip) [ Time Frame: Baseline to 10 days (24 hours each day) ]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.
- Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132570
|Contact: Zhang Lilifirstname.lastname@example.org|
|Beijing Tongren Hospital, Cmu||Recruiting|
|Beijing, Beijing, China, 100730|
|Baoding First Center Hospital||Withdrawn|
|Baoding, Hebei, China, 71028|
|The No.2 Hospital of Baoding||Recruiting|
|Baoding, Hebei, China, 71051|
|Cangzhou Center Hospital||Recruiting|
|Cangzhou, Hebei, China, 61000|
|The Second Hospital to Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 50000|
|Shandong provincial hospital||Recruiting|
|Jinan, Shandong, China, 250117|
|Principal Investigator: Guanggang Shi|
|The No.2 People'S Hospital Og Weifang||Recruiting|
|Weifang, Shandong, China, 261041|
|Principal Investigator:||Luo Zhang||BEIJING TONGREN HOSPITAL, CMU|
|Principal Investigator:||Chunguang Shan||THE SECOND HOSPITAL TO HEBEI MEDICAL UNIVERSITY|
|Principal Investigator:||Weiwei Liu||Cangzhou Center Hospital|
|Principal Investigator:||Guoji Zhang||BAODING FIRST CENTER HOSPITAL|
|Principal Investigator:||Yaozhong Han||THE NO.2 HOSPITAL OF BAODING|
|Principal Investigator:||Yongjian Ma||THE NO.2 PEOPLE'S HOSPITAL OG WEIFANG|
|Principal Investigator:||Guanggang Shi||Shandong Provincial Hospital|