Trial · NCT01847131
Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
NCT01847131, Phase 4, Completed, Mahidol University; results first posted 2015-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction. Trials, record NCT01847131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01847131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
- NCT number
- NCT01847131
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 50 participants, actual
- Lead sponsor
- Mahidol University
- Conditions
- Nasal Obstruction Present Finding
- Interventions
- oxymetazoline, Placebo nasal spray
- First posted
- 2013-05-06
- Last updated
- 2015-01-05
- Results first posted
- 2015-01-05
- Limitations and caveats
Further studies with larger numbers of subjects and longer period of follow-up would probably have led to significant differences between both treatment groups in NPIF, Rcq scores and the possible rebound nasal congestion or other adverse events.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | 6 weeks | Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group. |
| Secondary | The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | 6 weeks | Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (\>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | 6 weeks | units on a scale | GEOMETRIC_MEAN | |
| SECONDARY | The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | 6 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | Oxymetazoline | 1.38 | 95% Confidence Interval 0.95 to 1.81 | units on a scale | |
| Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | Placebo | 1.67 | 95% Confidence Interval 1.19 to 2.15 | units on a scale | |
| The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | Oxymetazoline | 0 | participants | ||
| The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | Placebo | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxymetazoline | 25 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Oxymetazoline | 25 | |
| Overall Study | COMPLETED | Placebo | 25 | |
| Overall Study | NOT COMPLETED | Oxymetazoline | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Oxymetazoline | 9 | 25 | 9 |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 25 | 9 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Oxymetazoline | 5 | 25 | 5 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 6 | 25 | 6 |
| other | Headache | Nervous system disorders | Oxymetazoline | 1 | 25 | 1 |
| other | Headache | Nervous system disorders | Placebo | 3 | 25 | 3 |
| other | Insomnia | General disorders | Oxymetazoline | 1 | 25 | 1 |
| other | Insomnia | General disorders | Placebo | 0 | 25 | 0 |
| other | Numbness at lips or tongue | General disorders | Oxymetazoline | 1 | 25 | 1 |
| other | Numbness at lips or tongue | General disorders | Placebo | 1 | 25 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxymetazoline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Oxymetazoline | 17 | 25 |
| Total, other adverse events | Placebo | 20 | 25 |
| Total, serious adverse events | Oxymetazoline | 0 | 25 |
| Total, serious adverse events | Placebo | 0 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oxymetazoline vs Placebo: The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | Trial comparisons |
| Oxymetazoline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01847131
GET https://conductscience.org/api/trials/v1/NCT01847131/registered