Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

This study is currently recruiting participants.
Verified October 2013 by Optinose US Inc.
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.
ClinicalTrials.gov Identifier:
NCT01624662
First received: June 13, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis.


Condition Intervention Phase
Bilateral Nasal Polyposis
Drug: fluticasone propionate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 16-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety

Resource links provided by NLM:


Further study details as provided by Optinose US Inc.:

Primary Outcome Measures:
  • reduction of nasal congestion/obstruction symptoms [ Time Frame: at the end of Week 4 of the double-blind treatment phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: October 2013
Arms Assigned Interventions
Active Comparator: fluticasone propionate 100 μg Twice a Day Drug: fluticasone propionate
Active Comparator: fluticasone propionate 200 μg Twice a Day Drug: fluticasone propionate
Active Comparator: fluticasone propionate 400 μg Twice a Day Drug: fluticasone propionate
Placebo Comparator: Matching placebo Drug: fluticasone propionate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (B-hCG) or urine pregnancy test (depending on local regulations) at the screening visit
  • Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by the Lildholdt scale score measured by nasoendoscopy at both screening and baseline visits
  • Must have at least moderate symptoms of nasal congestion/obstruction as reported by the subject for the 7 day period preceding the screening visit
  • At the baseline visit (Day 1), must have a morning score of at least 2 (moderate) on nasal congestion/obstruction recorded on the subject diary for at least 5 of the last 7 days of the 7 to up to 14 day run-in period
  • Must demonstrate an ability to correctly complete the daily diary during the run-in period to be eligible for randomization
  • 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) for at least 3 months before screening with plans to continue use throughout the study.
  • Must be able to cease treatment with intranasal medications including, but not limited to, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for comorbid asthma and COPD) at the screening visit
  • Must be able to cease treatment with oral and nasal decongestants and antihistamines 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 screening, Visit 1.
  • 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
  • Have complete or near-complete obstruction of the nasal cavities
  • Inability to achieve bilateral nasal airflow for any reason including nasal septum deviation
  • 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/nasal endoscopy
  • History of more than 5 sinonasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
  • History of sinus or nasal surgery within 6 months before the screening visit
  • History of any surgical procedure that prevents the ability to accurately grade polyps
  • Have symptoms of seasonal allergic rhinitis at screening or baseline and/or, based on time of year, would anticipate onset of symptoms within 4 weeks of randomization
  • 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 Note: Subjects who are taking prophylactic antibiotics will be allowed to enter the study as long as they intend to continue the antibiotics for the duration of the study.
  • 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.
  • History or current diagnosis of any form of glaucoma or ocular hypertension (ie, >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, with the exception of prescribed medications for legitimate medical conditions
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624662

Contacts
Contact: James Bambrick 215-591-7125 JBambrick@pharmanet-i3.com

Locations
United States, Maryland
Institute for Asthma and Allergy Recruiting
Wheaton, Maryland, United States, 20902
United States, Washington
Bellingham Asthma, Allergy, and Immunology Clinic Recruiting
Bellingham, Washington, United States, 98225
Sponsors and Collaborators
Optinose US Inc.
  More Information

No publications provided

Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01624662     History of Changes
Other Study ID Numbers: OPN-FLU-NP-3102
Study First Received: June 13, 2012
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014