| 1 |
NCT02967731 |
Active, not recruiting |
480 Biomedical Sinus Drug Depot |
|
- Drug: 480 Mometasone Furoate Sinus Drug Depot
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Product related serious adverse events from baseline visit to 4 weeks post procedure
- Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02967731 |
480MFSDD2016-001 |
|
June 6, 2017 |
February 2018 |
June 2018 |
November 18, 2016 |
January 3, 2018 |
|
- The Queen Elizabeth Hospital
Adelaide, Australia - Royal Brisbane and Women's Hospital
Brisbane, Australia - Monash Medical Center
Melbourne, Australia - University of Auckland
Auckland, New Zealand
|
| 2 |
NCT02266810 |
Completed
Has Results |
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus |
|
- Device: PROPEL Mini Sinus Implant.
- Procedure: Sinus Surgery alone
- Device: Propel Nova Sinus Implant
|
Interventional |
Phase 3 |
- Intersect ENT
- Advance Research Associates
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
- Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
- Need for Post-operative Interventions (Propel Mini Cohort)
- (and 7 more...)
|
160 |
All |
18 Years and older (Adult, Senior) |
NCT02266810 |
P500-0514 |
PROGRESS |
September 2014 |
April 2016 |
October 2016 |
October 17, 2014 |
October 6, 2017 |
October 6, 2017 |
- Sacramento Ear, Nose and Throat
Sacramento, California, United States - Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States - The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States - (and 7 more...)
|
| 3 |
NCT02228720 |
Completed
Has Results |
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia |
|
- Device: Propel Nova Sinus Implant
|
Interventional |
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- Device Placement Success Rate
- Ostial Patency
- Adhesion/Scarring Grade 2 & 3
- (and 2 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT02228720 |
P500-0414 |
EXCEED |
June 2014 |
October 2014 |
January 2015 |
August 29, 2014 |
August 4, 2017 |
August 4, 2017 |
- South Florida ENT Associates
Miami, Florida, United States - Ohio Sinus Institute
Dublin, Ohio, United States
|
| 4 |
NCT00423176 |
Terminated
Has Results |
The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) |
|
- Drug: MFNS and antibiotic
- Drug: Matching Placebo nasal spray plus antibiotic
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.
- Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline
|
237 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00423176 |
P04824 |
|
December 2006 |
June 2008 |
June 2008 |
January 18, 2007 |
April 12, 2017 |
June 22, 2010 |
|
| 5 |
NCT02291549 |
Completed |
Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients |
- Chronic Sinusitis
- Nasal Polyposis
|
- Drug: S8 Sinus Implant
- Drug: Nasonex steroid nasal spray
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in Nasal Obstruction/Congestion Score from baseline to Day 30
- Change in bilateral polyp grade from baseline to Day 90
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02291549 |
P500-1113 |
RESOLVEII |
December 2014 |
October 2016 |
October 2016 |
November 14, 2014 |
August 18, 2017 |
|
- The University of Alabama Birmingham
Birmingham, Alabama, United States - Kaiser Permanente Orange County Irvine Medical Center
Irvine, California, United States - Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
Sacramento, California, United States - (and 37 more...)
|
| 6 |
NCT01920893 |
Completed
Has Results |
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis |
|
- Drug: Placebo (for dupilumab)
- Drug: Dupilumab
- Drug: Mometasone furoate nasal spray
|
Interventional |
Phase 2 |
- Sanofi
- Regeneron Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
- Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma
- Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16
- (and 7 more...)
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT01920893 |
ACT12340
2013-001803-35
U1111-1130-6475 |
|
August 2013 |
November 2014 |
November 2014 |
August 12, 2013 |
June 26, 2017 |
June 2, 2017 |
- Investigational Site Number 840014
Rolling Hills Estates, California, United States - Investigational Site Number 840015
Denver, Colorado, United States - Investigational Site Number 840013
Boston, Massachusetts, United States - (and 11 more...)
|
| 7 |
NCT02687438 |
Completed |
The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery |
|
- Device: Steroid-releasing sinus implant
- Other: Post-op standard of care
|
Interventional |
Not Applicable |
- ENT and Allergy Associates, LLP
- Intersect ENT
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the change from baseline to day 90 in nasal obstruction / congestion score
- the change from baseline to day 90 in bilateral polyp grade
- Ethmoid Sinus Obstruction
- (and 9 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02687438 |
PIO III |
|
December 2015 |
February 2016 |
February 2016 |
February 22, 2016 |
November 17, 2016 |
|
- ENT and Allergy Associates, LLP
Lake Success, New York, United States - ENT and Allergy Associates, LLP
New York, New York, United States - ENT and Allergy Associates, LLP
Port Jefferson, New York, United States - ENT and Allergy Associates, LLP
White Plains, New York, United States
|
| 8 |
NCT01894503 |
Completed |
Safety and Performance of the Steroid-Releasing S8 Sinus Implant |
|
- Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Successful deployment on implant into the ethmoid sinus
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT01894503 |
P500-0513 |
S8PK |
June 2013 |
October 2013 |
October 2013 |
July 10, 2013 |
March 14, 2017 |
|
- Sacramento ENT
Sacramento, California, United States
|
| 9 |
NCT01732536 |
Completed |
Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction |
|
- Drug: S8 Sinus Implant
- Procedure: Sham procedure
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- nasal obstruction/congestion
- nasal polyposis
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01732536 |
P500-1012 |
RESOLVE |
January 2013 |
November 2013 |
May 2014 |
November 26, 2012 |
March 21, 2017 |
|
- California Sinus Centers
Atherton, California, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Sacramento Ear, Nose and Throat
Sacramento, California, United States - (and 16 more...)
|
| 10 |
NCT02880514 |
Active, not recruiting |
A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation |
|
- Device: Propel Mini Sinus Implant
- Procedure: In-office Sinus Dilation
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02880514 |
P500-0616 |
FRONTIER |
August 2016 |
September 2017 |
September 2017 |
August 26, 2016 |
March 21, 2017 |
|
- Sacramento ENT
Sacramento, California, United States - ENT Assoicates of South Florida
Boca Raton, Florida, United States - ENT of Georgia
Atlanta, Georgia, United States - (and 6 more...)
|
| 11 |
NCT03358329 |
Active, not recruiting |
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) |
- Chronic Sinusitis
- Nasal Polyposis
|
- Combination Product: S8 Sinus Implant
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03358329 |
P500-0717 |
|
November 13, 2017 |
January 3, 2018 |
March 15, 2019 |
November 30, 2017 |
January 29, 2018 |
|
- Sacramento ENT
Sacramento, California, United States - Yale University School of Medicine
New Haven, Connecticut, United States - DuPage Medical Group
Naperville, Illinois, United States - (and 6 more...)
|
| 12 |
NCT02668302 |
Completed |
The PIO II Study of In-office Placement of a Steroid-eluting Sinus Implant |
|
- Device: Steroid-releasing sinus implant
- Other: Post-op standard of care
|
Interventional |
Phase 4 |
- Collin County Ear Nose & Throat
- Intersect ENT
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Inflammation score
- Percent Ethmoid Sinus Obstruction
- Bilateral polyp grade
- (and 6 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02668302 |
P2015-09 |
|
November 2015 |
November 2016 |
November 2016 |
January 29, 2016 |
November 23, 2016 |
|
- Collin County Ear Nose & Throat
Frisco, Texas, United States
|
| 13 |
NCT01118312 |
Completed
Has Results |
Study of Asthma and Nasal Steroids |
|
- Drug: Mometasone Furoate monohydrate
- Other: Placebo
|
Interventional |
Phase 4 |
- JHSPH Center for Clinical Trials
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Asthma Control Test (ACT)
- Childhood Asthma Control Test
|
388 |
All |
6 Years and older (Child, Adult, Senior) |
NCT01118312 |
ALAACRC-11
R01 HL089464-01A2
R01 HL00895101-01A2 |
STAN |
September 2010 |
June 2014 |
June 2015 |
May 6, 2010 |
November 30, 2015 |
November 30, 2015 |
- University of Arizona
Tucson, Arizona, United States - University of California, San Diego
San Diego, California, United States - National Jewish Health
Denver, Colorado, United States - (and 16 more...)
|
| 14 |
NCT01253577 |
Completed
Has Results |
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis |
|
- Device: Sinus Stent with drug coating
- Device: Non Coated Sinus Stent
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Sinuses Requiring Post-operative Intervention
- Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
- Percentage of Sinuses That Developed Frank Polyposis
|
105 |
All |
18 Years and older (Adult, Senior) |
NCT01253577 |
P500-1009 |
ADVANCE II |
December 2009 |
October 2010 |
October 2010 |
December 3, 2010 |
June 22, 2015 |
April 13, 2015 |
- Central California ENT
Fresno, California, United States - Colorado ENT & Allergy
Colorado Springs, Colorado, United States - Northwestern University
Chicago, Illinois, United States - (and 8 more...)
|
| 15 |
NCT02110654 |
Unknown † |
Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery |
- Sinusitis
- Nasal Polyps
- Asthma
|
- Drug: Montelukast
- Drug: mometasone furoate nasal spray
|
Interventional |
Phase 4 |
- First Affiliated Hospital, Sun Yat-Sen University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)
- Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)
- Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)
- (and 2 more...)
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02110654 |
20140329 |
|
June 2014 |
March 2016 |
June 2016 |
April 10, 2014 |
April 10, 2014 |
|
- the first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 16 |
NCT02874144 |
Enrolling by invitation |
Anti-Inflammatory Agent in Sinusitis |
|
- Drug: AZ compound
- Other: Collection of Biological Specimens
- Drug: Intranasal corticosteroid
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
|
60 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02874144 |
E1416 Sinus |
E1416 |
June 2016 |
June 2018 |
August 2018 |
August 22, 2016 |
August 22, 2016 |
|
|
| 17 |
NCT00750750 |
Completed |
Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683) |
|
- Drug: mometasone furoate nasal spray (MFNS)
- Drug: MFNS
- Drug: Amoxicillin
- Drug: Placebo
|
Interventional |
Phase 2 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Average AM/PM major-symptom score (sum of rhinorrhea, post nasal drip, nasal congestion/stuffiness, sinus headache, and facial pain/pressure/tenderness on palpation over the paranasal sinuses) over the Treatment Phase of 15 days.
- The total-, major-, and individual-symptom scores (for AM, PM, and AM/PM average) by week, and for Days 1-15, and 16-29.
- Time to onset of action in the major-symptom score, defined as the first day active treatment was statistically significantly different from placebo, and sustained thereafter.
- (and 2 more...)
|
981 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00750750 |
P02683 |
|
January 1, 2003 |
September 1, 2003 |
September 1, 2003 |
September 11, 2008 |
March 22, 2017 |
|
|
| 18 |
NCT00751075 |
Completed |
Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692) |
|
- Drug: mometasone furoate nasal spray (MFNS)
- Drug: MFNS
- Drug: Amoxicillin
- Drug: Placebo
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Average AM/PM major-symptom score (sum of rhinorrhea, post nasal drip, nasal congestion/stuffiness, sinus headache, and facial pain/pressure/tenderness on palpation over the paranasal sinuses) over the Treatment Phase of 15 days.
- The total-, major-, and individual-symptom scores (for AM, PM, and AM/PM average) by week, and for Days 1-15, and 16-29.
- Time to onset of action in the major-symptom score, defined as the first day active treatment was statistically significantly different from placebo, and sustained thereafter.
- (and 2 more...)
|
981 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00751075 |
P02692 |
|
December 1, 2003 |
May 6, 2004 |
June 22, 2004 |
September 11, 2008 |
March 23, 2017 |
|
|
| 19 |
NCT03011632 |
Recruiting |
Response of the Airway in Sinusitis and Asthma |
|
- Drug: Mometasone Nasal
- Drug: placebo mometasone
|
Interventional |
Phase 4 |
- Medical Universtity of Lodz
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Asthma Control Test for children (cACT™)
- SN-5
- Spirometry
- (and 4 more...)
|
150 |
All |
4 Years to 8 Years (Child) |
NCT03011632 |
RNN/153/16/KE |
RAISe |
January 2017 |
September 2018 |
March 2019 |
January 5, 2017 |
March 27, 2018 |
|
- Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Lodz, Poland
|
| 20 |
NCT01691677 |
Completed |
beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study |
|
- Drug: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
- Drug: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
|
Interventional |
Phase 3 |
- Chiesi Farmaceutici S.p.A.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- proportion of patients who will experience clinical success
- overall sinus symptoms
- changes of each symptom
- (and 6 more...)
|
166 |
All |
18 Years to 65 Years (Adult) |
NCT01691677 |
MC/PR/1400/007/11 |
CLEAR |
January 2013 |
January 2014 |
January 2014 |
September 25, 2012 |
March 29, 2017 |
|
- Ospedale Cisanello
Pisa, Italy - Policlinico Univesitario Gemelli
Roma, Italy - Policlinico Santa Maria alle Scotte
Siena, Italy
|
| 21 |
NCT01676415 |
Terminated
Has Results |
Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) |
- Chronic Rhinosinusitis Without Nasal Polyps
|
- Drug: Prednisone
- Drug: Topical mometasone
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SNOT-22 Questionnaire
- Lund-McKay Score From CT Scan
- Taskforce Symptom Inventory
- Medication Side-effect and Compliance Inventory
|
9 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01676415 |
18369 |
|
August 2012 |
January 2016 |
August 2016 |
August 30, 2012 |
March 30, 2018 |
May 8, 2017 |
- : Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center
Chicago, Illinois, United States
|
| 22 |
NCT03323866 |
Recruiting |
Mometasone vs Budesonide in CRS With Polyposis |
- Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
|
- Drug: Budesonide 0.5 MG/ML
- Drug: Mometasone nasal spray
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Disease specific quality of life questionnaire
- Endoscopic evaluation of the nasal cavities
|
56 |
All |
18 Years and older (Adult, Senior) |
NCT03323866 |
2017-1569 |
|
May 1, 2017 |
October 2018 |
October 2018 |
October 27, 2017 |
January 10, 2018 |
|
- Université de Sherbrooke
Sherbrooke, Quebec, Canada
|
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