A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution

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

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis
• Intervention / Treatment: Drug: Budesonide; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital, CMU
  • Hebei
    • Baoding, Hebei, China, 071051
      • The No.2 Hospital of Baoding
    • Cangzhou, Hebei, China, 061000
      • Cangzhou Center Hospital
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital to Hebei Medical University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Provincial Hospital
    • Weifang, Shandong, China, 261041
      • The No.2 People'S Hospital Og Weifang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Budesonide; Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\- 3 Days.; Other Names: 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.	Other: Placebo; Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\- 3 Days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Rhinitis; Budesonide; Airborne pollution
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: CCSURA001265 (Other Identifier: Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division); 5034003ALY4002 (Other Identifier: Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No