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

NCT04132570 | Completed Phase 4

• 2 other identifiers: CCSURA0012655034003ALY4002
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 6

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.

Conditions

Rhinitis

Keywords

Airborne pollution; Rhinitis; Budesonide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment

  Day 10 (+/-3)

• Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS)

  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)

  Baseline to 10 days (24 hours each day)

• Number of Participants With Adverse Events (AEs) as a Measure of Safety

  Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10)

Study Arms (2)

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.

Drug: Budesonide

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.

Other: Placebo

Interventions

Budesonide DRUG

Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\\- 3 Days.

Also known as: RHINOCORT

Budesonide 256 mcg per Day (Treatment A)

Placebo OTHER

Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\\- 3 Days.

Placebo (Treatment B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division: lead

Study Sites (6)

Beijing Tongren Hospital, Cmu

Beijing, Beijing Municipality, 100730, China

Location

The No.2 Hospital of Baoding

Baoding, Hebei, 071051, China

Location

Cangzhou Center Hospital

Cangzhou, Hebei, 061000, China

Location

The Second Hospital to Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Shandong provincial hospital

Jinan, Shandong, 250117, China

Location

The No.2 People'S Hospital Og Weifang

Weifang, Shandong, 261041, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rhinitis

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: October 22, 2019
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)