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RhinitisPhase 4NCT04132570

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

A Phase 4 study testing Budesonide in people with Rhinitis, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rhinitis
What is being tested?
Budesonide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
6 sitesChina
Study dates
22 Oct 2019to 22 Jan 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The No.2 Hospital of Baoding

    Baoding, Hebei, 071051

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing Municipality, 100730

  • Cangzhou Center Hospital

    Cangzhou, Hebei, 061000

  • Shandong provincial hospital

    Jinan, Shandong, 250117

  • The Second Hospital to Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The No.2 People'S Hospital Og Weifang

    Weifang, Shandong, 261041

Other trials in China

About this study

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

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
Being tested
Budesonide, Placebo
Keywords
Airborne pollution, Rhinitis, Budesonide
Medical subject headings
Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BudesonideDrug

    Also called RHINOCORT

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

  • PlaceboOther

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

Study groups in NCT04132570
Study groupRoleWhat they receive
Budesonide 256 mcg per Day (Treatment A)ExperimentalParticipants will self-administer 2 nasal sprays of Budesonide (64 microgram [mcg]/spray) in each nostril once daily (every morning) up to 10 +\- 3 Days.
Receives: Drug: Budesonide
Placebo (Treatment B)Placebo comparatorParticipants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 10 days (24 hours each day)

Secondary outcomes (4)

  1. 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.

    Measured: Day 10 (+/-3)

  2. 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.

    Measured: Baseline to 10 days (24 hours each day)

  3. 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.

    Measured: Baseline to 10 days (24 hours each day)

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start22 Oct 2019
  3. Primary completion22 Jan 2020
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132570
Sponsor's protocol ID
CCSURA001265
Other IDs
CCSURA001265, 5034003ALY4002
Status last verified
Jan 2021
First submitted
17 Oct 2019
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Budesonide in people with Rhinitis, run by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS) (time frame: Baseline up to 10 days (24 hours each day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04132570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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