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

Sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (Industry)

Overall Status

Completed

CT.gov ID

NCT04132570

Collaborator

(none)

206

Enrollment

Locations

Arms

Actual Duration (Months)

34.3

Patients Per Site

11.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis	Drug: Budesonide Other: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double blind

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 22, 2019

Actual Primary Completion Date :

Jan 22, 2020

Actual Study Completion Date :

Jan 22, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS) [Baseline up to 10 days (24 hours each day)]
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 [Day 10 (+/-3)]
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) [Baseline to 10 days (24 hours each day)]
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) [Baseline to 10 days (24 hours each day)]
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 [Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital, Cmu	Beijing	Beijing	China	100730
2	The No.2 Hospital of Baoding	Baoding	Hebei	China	071051
3	Cangzhou Center Hospital	Cangzhou	Hebei	China	061000
4	The Second Hospital to Hebei Medical University	Shijiazhuang	Hebei	China	050000
5	Shandong provincial hospital	Jinan	Shandong	China	250117
6	The No.2 People'S Hospital Og Weifang	Weifang	Shandong	China	261041

Sponsors and Collaborators

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