A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
NCT ID: NCT04132570
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
206 participants
INTERVENTIONAL
2019-10-22
2020-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Budesonide
Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\\- 3 Days.
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.
Placebo
Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\\- 3 Days.
Interventions
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Budesonide
Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\\- 3 Days.
Placebo
Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\\- 3 Days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have moderate to severe rhinitis symptoms as defined by a 24-hour reflective total nasal symptom score (rTNSS) of at least 5 (maximum 9), based on three individual nasal symptom scores (nasal obstruction, secretion/runny nose, itching/sneezing) at the time of the screening visit, including at least one individual symptom score of 3 for nasal obstruction and/or secretion/runny nose
* Regularly have outdoor exposure during a normal week in the winter season, including greater than or equal to (\>=) 1 hour on most days. Outdoor exposure may include commuting activities (such as walking/bicycle/auto/bus/city metro train travel), outdoor work, exercise, shopping, or other outdoor activities
* A woman of childbearing potential must have a negative urine pregnancy test (beta human chorionic gonadotropin \[beta hCG\]) at screening and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after the last administration of study agent
* Male participants who are not surgically sterilized and are heterosexually active with a woman of childbearing potential, must agree to use a barrier method of contraception (example condom with spermicidal foam/gel/film/cream/suppository) and to not donate sperm during the study and for 30 days after last receiving study agent. Note that barrier methods must also be used in all male subjects sexually active with pregnant partners for at least 30 days after last study agent administration
* Participants can understand the questionnaires and are able to complete the questionnaires in the format provided
* Reside in the same city as the study site that they will be visiting
Exclusion Criteria
* Upper respiratory infection within 2 weeks of screening visit
* Current symptoms consistent with diagnosis of common cold, influenza, or other respiratory infection according to physician evaluation
* Using of N-95 masks days during with high airborne pollution
* Presence of nasal polyps or deviated septum as confirmed by nasal endoscopy
* History of nasal surgery
* Presence of chronic or active rhinosinusitis or sinusitis
* Systemic, intranasal or topical corticosteroid use within 1 month, intranasal or systemic decongestants within 3 days, antihistamine use within 1 week, intranasal cromolyn within 2 weeks, leukotriene use within 1 month, or immunotherapy within 2 years of screening visit
* Asthma, with the exception of mild intermittent asthma not requiring medication
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (example compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
18 Years
80 Years
ALL
No
Sponsors
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Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
INDUSTRY
Responsible Party
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Principal Investigators
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Luo Zhang
Role: PRINCIPAL_INVESTIGATOR
BEIJING TONGREN HOSPITAL, CMU
Chunguang Shan
Role: PRINCIPAL_INVESTIGATOR
THE SECOND HOSPITAL TO HEBEI MEDICAL UNIVERSITY
Weiwei Liu
Role: PRINCIPAL_INVESTIGATOR
Cangzhou Center Hospital
Guoji Zhang
Role: PRINCIPAL_INVESTIGATOR
BAODING FIRST CENTER HOSPITAL
Yaozhong Han
Role: PRINCIPAL_INVESTIGATOR
The No. 2 Hospital of Baoding
Yongjian Ma
Role: PRINCIPAL_INVESTIGATOR
THE NO.2 PEOPLE'S HOSPITAL OG WEIFANG
Guanggang Shi
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Hospital
Locations
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Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, China
The No.2 Hospital of Baoding
Baoding, Hebei, China
Cangzhou Center Hospital
Cangzhou, Hebei, China
The Second Hospital to Hebei Medical University
Shijiazhuang, Hebei, China
Shandong provincial hospital
Jinan, Shandong, China
The No.2 People'S Hospital Og Weifang
Weifang, Shandong, China
Countries
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Related Links
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Other Identifiers
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CCSURA001265
Identifier Type: OTHER
Identifier Source: secondary_id
5034003ALY4002
Identifier Type: OTHER
Identifier Source: secondary_id
CCSURA001265
Identifier Type: -
Identifier Source: org_study_id
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