12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device

Nasal Polyps Clinical Trial

Official title:

12-Month OL Evaluating the Safety of Intranasal Administration Fluticasone BID Using OptiNose Device in Subjects With CS With or Without Nasal Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623310
• Other study ID #: OPN-FLU-CS-3203
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2012
• Last updated: January 23, 2018
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2018
• Source: Optinose US Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women aged 18 years and older Women must

• be practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or

• be surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation at least 1 year before screening) or otherwise be incapable of pregnancy, or

• be postmenopausal (spontaneous amenorrhea for at least 1 year).

• Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at the screening visit

• Have either:

a history of chronic sinusitis with bilateral nasal polyposis determined by nasoendoscopy at screening visit OR a history of chronic sinusitis (without polyps) for equal to or greater than 12 weeks and currently experiencing 2 or more of the following symptoms, one of which MUST be either nasal blockage/congestion or nasal discharge (anterior and/or posterior nasal discharge):

1. nasal blockage/congestion

2. nasal discharge (anterior and/or posterior nasal discharge)

3. facial pain or pressure

4. reduction or loss of smell

• Subjects with comorbid asthma or COPD must be stable with no exacerbations (eg, no emergency room visits, hospitalizations, or oral or parenteral steroid use)within the 3 months before the screening visit. Inhaled corticosteroid use must be limited to stable doses of no more than 1,000 µg/day of beclomethasone (or equivalent; See Attachment 1) for at least 3 months before screening with plans to continue use throughout the study.

• Must be able to cease treatment with intranasal steroids and inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at the screening visit

• Must be able to use the OptiNose device correctly; all subjects will be required to demonstrate correct use of the placebo device at the screening visit, see Section 12.1, Visit 1, screening procedures.

• Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Subjects must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Women who are pregnant or lactating

• Inability to have each nasal cavity examined for any reason, including nasal septum deviation

• Nasal septum perforation

• Has had more than 1 episode of epistaxis with frank bleeding in the month before the screening visit

• Have evidence of significant baseline mucosal injury, ulceration or erosion (eg, exposed cartilage, perforation) on baseline nasal examination/nasoendoscopy

• History of sinus or nasal surgery within 6 months before the screening visit

• Current, ongoing rhinitis medicamentosa (rebound rhinitis)

• Have significant oral structural abnormalities, eg, a cleft palate

• Diagnosis of cystic fibrosis

• History of Churg-Strauss syndrome or dyskinetic ciliary syndromes

• Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before the screening visit. Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution

• Planned sinonasal surgery during the period of the study

• Allergy, hypersensitivity, or contraindication to corticosteroids or steroids

• Allergy or hypersensitivity to any excipients in study drug

• Exposure to any glucocorticoid treatment with potential for systemic effects (eg, oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before the screening visit; except as noted in inclusion criteria for subjects with comorbid asthma or COPD

• Have nasal candidiasis

• Have taken a potent CYP3A4 inhibitor within 14 days before the screening visit; examples of these medications can be found in Section 11.6, Concomitant Medication.

• History or current diagnosis of any form of glaucoma or ocular hypertension (ie, intraocular pressure >21 mmHg)

• History of intraocular pressure elevation on any form of steroid therapy

• History or current diagnosis of the presence (in either eye) of a cataract

• Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study

• A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol use, abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study

• Positive urine drug screen at screening visit for drugs of abuse (see Section 14.5), with the exception of prescribed medications for legitimate medical conditions

• Have participated in a previous clinical trial of OPTINOSE FLUTICASONE

• Have participated in an investigational drug clinical trial within 30 days of the screening visit

• Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps

Intervention

Drug:
• Fluticasone Propionate
Using Optinose Exhalation Delivery System

Locations

Country	Name	City	State
United States	Achieve Clinical Research	Birmingham	Alabama
United States	PAB Clinical Research	Brandon	Florida
United States	Focus Clinical Research	Draper	Utah
United States	Allergy and Asthma Research Group	Eugene	Oregon
United States	Exemplar Research	Fairmont	West Virginia
United States	Clinical Research Solutions	Franklin	Tennessee
United States	William Blake Partners	Grapevine	Texas
United States	Allergy Asthma and Sinus Center	Greenfield	Wisconsin
United States	HCCA Clinical Research Solutions	Middleburg Heights	Ohio
United States	Best Clinical Trials	New Orleans	Louisiana
United States	Sneeze Wheeze and Itch Associates	Normal	Illinois
United States	InterMountain Ear Nose and Throat	Salt Lake City	Utah
United States	Premier Clinical Research	Spokane	Washington
United States	Advanced Clinical Research	West Jordan	Utah
United States	Professional Research Network of Kansas	Wichita	Kansas
United States	PMG Research of Winston Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Optinose US Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Patients with at least one Adverse Events	12 Months
Secondary	Sinonasal Outcome Test 22 (SNOT-22) Total Score	Change from baseline to Month 3 & Month 12 in SNOT-22 Total Score; SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. The total score can range from 0-110, 0 being the best and 110 being the worst.; 0: No problem; Very mild problem; Mild or slight problem; Moderate problem; Severe problem; Problem as bad as it can be	Baseline, Month 3, Month 12
Secondary	Lund-Mackay Total Score	Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score; Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome	Baseline, Month 3, Month 12
Secondary	Patient Global Impression of Change (PGIC)	The PGIC took less than 1 minute to complete. Subjects answered question, "Since starting the study drug, how would you rate the change in your symptoms?" Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time.	Baseline, Month 3, Month 12
Secondary	Summed Bilateral Nasal Polyp Grading Scale Score	In subjects with nasal polyps, polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.; 0: No polyps; Mild polyposis: polyps not reaching below the inferior of the middle turbinate; Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate; Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate	Baseline, Month 3, Month 12
Secondary	Nasal Polyp Surgery Eligibility		Baseline, Month 3, Month 12