Clinical trial NCT04132570: A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis
Keywords: Airborne pollution
Rhinitis
Budesonide
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Self-reported rhinitis symptoms triggered or worsened by airborne pollution, with agreement by physician at screening visit
* 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:

* History of hypersensitivity to budesonide or any ingredients in the formulation
* 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

Primary outcomes:
measure: Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Baseline up to 10 days (24 hours each day)
Secondary outcomes:
measure: Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment
timeFrame: Day 10 (+/-3)
measure: Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS)
timeFrame: Baseline to 10 days (24 hours each day)
measure: Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip)
timeFrame: Baseline to 10 days (24 hours each day)
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety
timeFrame: Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Cmu
state: Beijing
city: Baoding
country: China
facility: The No.2 Hospital of Baoding
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou Center Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital to Hebei Medical University
state: Hebei
city: Jinan
country: China
facility: Shandong provincial hospital
state: Shandong
city: Weifang
country: China
facility: The No.2 People'S Hospital Og Weifang
state: Shandong
Study officials:
affiliation: BEIJING TONGREN HOSPITAL, CMU
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: THE SECOND HOSPITAL TO HEBEI MEDICAL UNIVERSITY
name: Chunguang Shan
role: PRINCIPAL_INVESTIGATOR
affiliation: Cangzhou Center Hospital
name: Weiwei Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: BAODING FIRST CENTER HOSPITAL
name: Guoji Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The No. 2 Hospital of Baoding
name: Yaozhong Han
role: PRINCIPAL_INVESTIGATOR
affiliation: THE NO.2 PEOPLE'S HOSPITAL OG WEIFANG
name: Yongjian Ma
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Guanggang Shi
role: PRINCIPAL_INVESTIGATOR
References: