ACUTE SINUSITISNCT00552773
Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
A study testing Cyclamen Europaeum in people with ACUTE SINUSITIS, run by Dey at 25 sites in United States.
Trial summary
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ACUTE SINUSITIS
- What is being tested?
- Cyclamen Europaeum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 25 sitesUnited States
- Study dates
- Nov 2007to Dec 2009
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18-70
- Must be symptomatic on the basis of subject assessments of total sympton score.
- Evidence of mucopurulence on nasal endoscopy
- Evidence of inflammation upon nasal endoscopy
- CT scan with radiographic signs of acute sinusitis
- Able to complete all study activities or procedures through the end of the study, including all visits and tests, and capable of selfadministration of study medication
- Agree to abide by the study protocol and its restrictions
Who cannot join
- Known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis
- Known hypersensitivity to Cyclamen, Primula, or other Primulaceae
- Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease.
- Abnormal screening laboratory/imaging test results
- Condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, Stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect)
- Expansile mass or bony erosion on sinus radiograph
Show all 19Show fewer
- Females who are pregnant, planning to become pregnant or currently breastfeeding.
- History of viral upper respiratory infection (URI) in the past 2 weeks
- Temperature greater than 102.5°F
- Facial or periorbital edema
- Local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess
- Altered mental status
- Recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months
- Use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days
- Use of oral and/or topical nasal decongestants within the previous 7 days
- Had radiation therapy or chemotherapy within the previous 12 months
- Have used an investigational drug or device within 30 days prior to screening
- Have a history of illegal drug or alcohol abuse within the past 5 years
- Have major unstable organ system disease that could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives Subjects who have asthma, seasonal and/or perennial allergic rhinitis will be allowed to enter the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Austin Ear, Nose and Throat Clinic
Austin, Texas, 78707
West Lake Ffamily Practice/Time Point Clinical Research
Austin, Texas, 78746
Alliance Clinical Research
Birmingham, Alabama, 35215
Health Science Research Center
Cortland, New York, 13045
Southeast Clinical Research
Gainsville, Florida, 32601
Greenville Pharmaceutical Research
Greenville, South Carolina, 28615
ADAC Research, PA
Greenville, South Carolina, 29607
Las Vegas Physicians Research Group
Henderson, Nevada, 89052
Clinical Research Connections
Jonesboro, Arkansas, 72401
Medical Research Associates of Central ew York, PLLC
North Syracuse, New York, 13212
Memorial Clinical Research
Oklahoma City, Oklahoma, 73134
Carolina Research
Orangeberg, South Carolina, 29118
Peak Medical Research, LLC
Owensboro, Kentucky, 42303
Center of Research Excellence, LLC
Oxford, Alabama, 36206
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003
American Institute of Healthcare and Fitness Clinical Research
Raleigh, North Carolina, 27615
Virginia Adult and Pediatric Allergy and Asthma, PC
Richmond, Virginia, 23229
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, 78229
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233
Jones Family Pratice
Shelby, North Carolina, 28150
Clinical Health Research LLC
Sugar Land, Texas, 77479
Orlando Rangel, MD, PA
Tampa, Florida, 33607
LAND Clinical Studies, LLC
West Caldwell, New Jersey, 07006
Premier Health Research Center
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Group Trial of Cyclamen Europaeum Extract Nasal Spray 10% (v/v) in the Treatment of Subjects With Acute Sinusitis
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
- Conditions
- ACUTE SINUSITIS
- Being tested
- Cyclamen Europaeum
- Keywords
- SINUSITIS, CYCLAMEN
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclamen EuropaeumDrug
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Cyclamen Europaeum | Experimental | Not described Receives: Drug: Cyclamen Europaeum |
| Placebo | Placebo comparator | Not described Receives: Drug: Cyclamen Europaeum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans.
Measured: 1 year
Secondary outcomes (1)
TSS change from Baseline to each post-dose visit for each symptom scoring Change from Baseline for the individual symptom scores Time to cure rate Frequency of acute sinusitis episodes The presence/absence of mucopurulence and inflamed nasal mucosa
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACUTE SINUSITISStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelique Barreto, MD, Principal investigator, Memorial Clinical Reasearch, OK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552773
- Sponsor's protocol ID
- 434-083
- Status last verified
- Nov 2011
- First submitted
- 31 Oct 2007
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Parallel Group Trial of Cyclamen Europaeum Extract Nasal Spray 10% (v/v) in the Treatment of Subjects With Acute Sinusitis
- ClinicalTrials.gov ID
- NCT00552773
- Acronym / sponsor ID
- 434-083
- Conditions
- ACUTE SINUSITIS
- Keywords
- SINUSITIS, CYCLAMEN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- DeyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclamen Europaeum | Experimental | Drug: Cyclamen Europaeum |
| Placebo | Placebo comparator | Drug: Cyclamen Europaeum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults age 18-70
- Must be symptomatic on the basis of subject assessments of total sympton score.
- Evidence of mucopurulence on nasal endoscopy
- Evidence of inflammation upon nasal endoscopy
- CT scan with radiographic signs of acute sinusitis
Key exclusion criteria (19 listed)
- Known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis
- Known hypersensitivity to Cyclamen, Primula, or other Primulaceae
- Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease.
- Abnormal screening laboratory/imaging test results
- Condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, Stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect)
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 |
|---|---|---|
| Cyclamen EuropaeumNasal spray 10% (V/V),one spray per nostril daily for 7 days. | Drug | Cyclamen Europaeum, Placebo |
Primary outcome
Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans.
Time frame: 1 year
1 secondary outcome
TSS change from Baseline to each post-dose visit for each symptom scoring Change from Baseline for the individual symptom scores Time to cure rate Frequency of acute sinusitis episodes The presence/absence of mucopurulence and inflamed nasal mucosa
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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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.
Angelique Barreto, MD principal investigator
Memorial Clinical Reasearch, OK
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclamen Europaeum in people with ACUTE SINUSITIS, run by Dey at 25 sites 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 7 inclusion and 19 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 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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.
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?
Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2013.