Allergic RhinitisPhase 4NCT00584987
Intranasal Steroids and Oxymetazoline in Allergic Rhinitis
A Phase 4 study testing Fluticasone furoate and Oxymetazoline in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Fluticasone furoate and Oxymetazoline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- And a combined nasal morning and evening score of ≥4 for nasal congestion in the day preceding entry
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
Show all 10Show fewer
- Subjects treated with immunotherapy and are escalating their dose.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Upper respiratory infection within 14 days of study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa
We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.
Read the detailed description
We performed a 6-week, 4-group, parallel, randomized, double-blind, double-dummy, clinical trial in 60 patients with perennial allergic rhinitis. After an initial screening with an allergy questionnaire and skin puncture testing to confirm an allergic response to a perennial allergen (cat, dog, dust mite, indoor mold), qualified individuals were randomized into 1 of 4 treatment groups. The 4 groups received the following treatments: placebo, OXY (0.05%, 2 puffs in each nostril every evening), FF nasal spray (110 mg per day), and FF nasal spray plus OXY (FF/OXY). All participants received 2 nasal sprays at night, with 1 spray containing FF or its placebo, the other oxymetazoline or its placebo. The nasal sprays were labeled with participant code numbers, and the investigator assigned participants in a sequential randomized fashion to a study code number in blocks of 4. Dropouts were replaced until 60 subjects were randomized. Replacement subjects were assigned the next sequential treatment. Thus, the number of subjects in each group was not exactly 15.
Eligible participants completed the Rhinitis Quality of Life Questionnaire (RQLQ) and underwent measurement of nasal volume by acoustic rhinometry before starting the study. Participants were instructed to keep a diary of daily symptoms, nasal peak inspiratory flow (NPIF) meter readings, and medication use during the study; no rescue medications were allowed. The severity of sneezing, rhinorrhea, nasal congestion, and other symptoms was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. Intake of the study medication was performed once daily, at night, after recording of symptoms and NPIF values. Subjects returned to the nasal laboratory every 2 weeks for a total of 4 weeks for review of the symptom diaries, replacement of medications, performance of acoustic rhinometry, and completion of the RQLQ. After the fourth week, participants stopped treatment, returned medication, and continued with the clinical trial for 2 additional weeks. During this time, they maintained symptom diaries and NPIF measurements twice daily. At the end of the 2-week period, participants returned to the nasal laboratory to perform a final acoustic rhinometry, complete an RQLQ survey, and return the diaries.
- Conditions
- Allergic Rhinitis
- Being tested
- Fluticasone furoate, Placebo Fluticasone furoate, Oxymetazoline, Placebo Oxymetazoline
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoateDrug
Also called Veramyst
2 puffs of each nasal spray in each nostril in the pm
Placebo Fluticasone furoateDrug
2 puffs of each nasal spray in each nostril in the pm
OxymetazolineDrug
Also called Oxymetazoline hydrochloride
2 puffs of each nasal spray in each nostril in the pm
Placebo OxymetazolineDrug
2 puffs of each nasal spray in each nostril in the pm
| Study group | Role | What they receive |
|---|---|---|
| Placebo FF + Placebo OXY | Placebo comparator | Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm Receives: Drug: Placebo Fluticasone furoate; Drug: Placebo Oxymetazoline |
| FF + Placebo OXY | Active comparator | Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm Receives: Drug: Fluticasone furoate; Drug: Placebo Oxymetazoline |
| Placebo FF + OXY | Active comparator | Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm Receives: Drug: Placebo Fluticasone furoate; Drug: Oxymetazoline |
| FF + OXY | Active comparator | Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm Receives: Drug: Fluticasone furoate; Drug: Oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Congestion Symptom Score
The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).
Measured: 28 days of treatment
Secondary outcomes (5)
RQLQ Score [Baseline]
The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.
Measured: assessed at baseline
RQLQ Score [2 Weeks]
The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.
Measured: assessed 2 weeks after initiation of treatment regimen
RQLQ Score [4 Weeks]
The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.
Measured: assessed 4 weeks after initiation of treatment regimen
RQLQ Score [6 Weeks]
The Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.
Measured: assessed 6 weeks after initiation of treatment regimen
Total NPIF
Nasal peak inspiratory flow (NPIF) is a physiological measure of nasal airflow which is particularly sensitive to nasal valve collapse. NPIF was measured objectively in liters per minute with an In-Check Peak Inspiratory FlowMeter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and recorded the best flow measured. The morning and evening NPIF measurements were summed for days 2 through 28 of the treatment cycle, yielding the total NPIF outcome measure. NPIF scores increase with air flow quality (i.e., higher NPIF values are indicative of better nasal air flow).
Measured: days 2 through 28 of the treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Robert Naclerio, University of Chicago
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584987
- Sponsor's protocol ID
- 15059B
- Status last verified
- Oct 2013
- First submitted
- 21 Dec 2007
- Last updated
- 17 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Baroody FM, Brown D, Gavanescu L, DeTineo M, Naclerio RM. Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2011 Apr;127(4):927-34. doi: 10.1016/j.jaci.2011.01.037. Epub 2011 Mar 5.
PubMed 21377716
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Intranasal Steroid/Oxymetazoline Leads to Faster Relief of Nasal Congestion Without Inducing Rhinitis Medicamentosa
- ClinicalTrials.gov ID
- NCT00584987
- Acronym / sponsor ID
- 15059B
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Jan 2008 (estimated)
- Results
- Posted 17 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.
Detailed description
We performed a 6-week, 4-group, parallel, randomized, double-blind, double-dummy, clinical trial in 60 patients with perennial allergic rhinitis. After an initial screening with an allergy questionnaire and skin puncture testing to confirm an allergic response to a perennial allergen (cat, dog, dust mite, indoor mold), qualified individuals were randomized into 1 of 4 treatment groups. The 4 groups received the following treatments: placebo, OXY (0.05%, 2 puffs in each nostril every evening), FF nasal spray (110 mg per day), and FF nasal spray plus OXY (FF/OXY). All participants received 2 nasal sprays at night, with 1 spray containing FF or its placebo, the other oxymetazoline or its placebo. The nasal sprays were labeled with participant code numbers, and the investigator assigned participants in a sequential randomized fashion to a study code number in blocks of 4. Dropouts were replaced until 60 subjects were randomized. Replacement subjects were assigned the next sequential treatment. Thus, the number of subjects in each group was not exactly 15.
Eligible participants completed the Rhinitis Quality of Life Questionnaire (RQLQ) and underwent measurement of nasal volume by acoustic rhinometry before starting the study. Participants were instructed to keep a diary of daily symptoms, nasal peak inspiratory flow (NPIF) meter readings, and medication use during the study; no rescue medications were allowed. The severity of sneezing, rhinorrhea, nasal congestion, and other symptoms was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. Intake of the study medication was performed once daily, at night, after recording of symptoms and NPIF values. Subjects returned to the nasal laboratory every 2 weeks for a total of 4 weeks for review of the symptom diaries, replacement of medications, performance of acoustic rhinometry, and completion of the RQLQ. After the fourth week, participants stopped treatment, returned medication, and continued with the clinical trial for 2 additional weeks. During this time, they maintained symptom diaries and NPIF measurements twice daily. At the end of the 2-week period, participants returned to the nasal laboratory to perform a final acoustic rhinometry, complete an RQLQ survey, and return the diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo FF + Placebo OXY | Placebo comparator | Drug: Placebo Fluticasone furoate, Drug: Placebo OxymetazolinePlacebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm |
| FF + Placebo OXY | Active comparator | Drug: Fluticasone furoate, Drug: Placebo OxymetazolineFluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm |
| Placebo FF + OXY | Active comparator | Drug: Placebo Fluticasone furoate, Drug: OxymetazolinePlacebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm |
| FF + OXY | Active comparator | Drug: Fluticasone furoate, Drug: OxymetazolineFluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- And a combined nasal morning and evening score of ≥4 for nasal congestion in the day preceding entry
Key exclusion criteria (10 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone furoateAlso: Veramyst2 puffs of each nasal spray in each nostril in the pm | Drug | FF + OXY, FF + Placebo OXY |
| Placebo Fluticasone furoate2 puffs of each nasal spray in each nostril in the pm | Drug | Placebo FF + OXY, Placebo FF + Placebo OXY |
| OxymetazolineAlso: Oxymetazoline hydrochloride2 puffs of each nasal spray in each nostril in the pm | Drug | FF + OXY, Placebo FF + OXY |
| Placebo Oxymetazoline2 puffs of each nasal spray in each nostril in the pm | Drug | FF + Placebo OXY, Placebo FF + Placebo OXY |
Primary outcome
Total Nasal Congestion Symptom Score
Time frame: 28 days of treatment
The severity of nasal congestion was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. The total nasal congestion symptom score was obtained by adding the symptoms obtained on all 28 days of treatment. Values for this outcome are in the range of 0 to 168 (i.e., 6 x 28). Congestion scores increase with congestion severity (i.e., higher numbers correspond to worse congestion).
5 secondary outcomes
RQLQ Score [Baseline]
Time frame: assessed at baseline
RQLQ Score [2 Weeks]
Time frame: assessed 2 weeks after initiation of treatment regimen
RQLQ Score [4 Weeks]
Time frame: assessed 4 weeks after initiation of treatment regimen
RQLQ Score [6 Weeks]
Time frame: assessed 6 weeks after initiation of treatment regimen
Total NPIF
Time frame: days 2 through 28 of the treatment cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21377716Baroody FM, Brown D, Gavanescu L, DeTineo M, Naclerio RM. Oxymetazoline adds to the effectiveness of fluticasone furoate in the treatment of perennial allergic rhinitis. J Allergy Clin Immunol. 2011 Apr;127(4):927-34. doi: 10.1016/j.jaci.2011.01.037. Epub 2011 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone furoate and Oxymetazoline in people with Allergic Rhinitis, run by University of Chicago at 1 site in United States.
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 4 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Nasal Congestion Symptom Score (time frame: 28 days of treatment). 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 NCT00584987, which also lists 1 linked publication.
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 17 Dec 2013.