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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132570
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 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 : October 22, 2019
Estimated Primary Completion Date : March 13, 2020
Estimated Study Completion Date : September 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

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 Name: 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.




Primary Outcome Measures :
  1. Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: 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 :
  1. Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment [ Time Frame: 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.

  2. Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS) [ Time Frame: 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.

  3. Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip) [ Time Frame: 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.

  4. Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132570


Contacts
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Contact: Zhang Lili +86-021-33378598 lzhan262@its.jnj.com

Locations
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China, Beijing
Beijing Tongren Hospital, Cmu Recruiting
Beijing, Beijing, China, 100730
China, Hebei
Baoding First Center Hospital Withdrawn
Baoding, Hebei, China, 71028
The No.2 Hospital of Baoding Not yet recruiting
Baoding, Hebei, China, 71051
Cangzhou Center Hospital Not yet recruiting
Cangzhou, Hebei, China, 61000
The Second Hospital to Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 50000
China, Shandong
Shandong provincial hospital Not yet recruiting
Jinan, Shandong, China, 250117
Principal Investigator: Guanggang Shi         
The No.2 People'S Hospital Og Weifang Not yet recruiting
Weifang, Shandong, China, 261041
Sponsors and Collaborators
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Investigators
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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

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Responsible Party: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
ClinicalTrials.gov Identifier: NCT04132570    
Other Study ID Numbers: CCSURA001265
CCSURA001265 ( Other Identifier: Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division )
5034003ALY4002 ( Other Identifier: Johnson & Johnson Consumer, Inc., McNeil Consumer Healthcare Division )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ):
Airborne pollution
Rhinitis
Budesonide
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists