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| ID | Type | Description | Link |
|---|---|---|---|
| CCSURA001265 | Other Identifier | Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division | |
| 5034003ALY4002 | Other Identifier | Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide 256 mcg per Day (Treatment A) | Experimental | 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. |
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| Placebo (Treatment B) | Placebo Comparator | Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\- 3 Days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 10 days (24 hours each day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 10 (+/-3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Cmu | Beijing | Beijing Municipality | 100730 | China | ||
| The No.2 Hospital of Baoding |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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Double blind
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| Placebo | Other | Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\- 3 Days. |
|
| 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. |
| 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. | 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. | Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10) |
| Baoding |
| Hebei |
| 071051 |
| China |
| Cangzhou Center Hospital | Cangzhou | Hebei | 061000 | China |
| The Second Hospital to Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Shandong provincial hospital | Jinan | Shandong | 250117 | China |
| The No.2 People'S Hospital Og Weifang | Weifang | Shandong | 261041 | China |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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