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

Primary Purpose

Rhinitis

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Budesonide

Placebo

About this trial

This is an interventional treatment trial for Rhinitis focused on measuring Airborne pollution, Rhinitis, Budesonide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Tongren Hospital, Cmu
The No.2 Hospital of Baoding
Cangzhou Center Hospital
The Second Hospital to Hebei Medical University
Shandong provincial hospital
The No.2 People'S Hospital Og Weifang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Budesonide 256 mcg per Day (Treatment A)

Placebo (Treatment B)

Arm Description

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.

Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT04132570

First Posted

October 17, 2019

Last Updated

January 20, 2021

Sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

1. Study Identification

Unique Protocol Identification Number

NCT04132570

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

October 22, 2019 (Actual)

Primary Completion Date

January 22, 2020 (Actual)

Study Completion Date

January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis

Keywords

Airborne pollution, Rhinitis, Budesonide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide 256 mcg per Day (Treatment A)

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo (Treatment B)

Arm Type

Placebo Comparator

Arm Description

Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days.

Intervention Type

Drug

Intervention Name(s)

Budesonide

Other Intervention Name(s)

RHINOCORT

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)

Description

Time Frame

Baseline up to 10 days (24 hours each day)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Day 10 (+/-3)

Title

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

Description

Time Frame

Baseline to 10 days (24 hours each day)

Title

Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip)

Description

Time Frame

Baseline to 10 days (24 hours each day)

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials: