A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis

NCT01916226 | Completed Phase 4 Results

• 1 other identifier: 200165
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 31

Brief Summary

This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Keywords

cetirizine; seasonal allergic rhinitis; Quality of Life; fluticasone propionate nasal spray

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period

  The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.

  Baseline through the entire treatment period (2 weeks)

Secondary Outcomes (6)

• Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period

  Baseline through the entire treatment period (2 weeks)

• Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.

  Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal

• Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period

  Baseline through the entire treatment period (2 weeks)

• Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period

  Baseline through the entire treatment period (2 weeks)

• Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period

  Baseline through the entire treatment period (2 weeks)

Study Arms (4)

FPNS arm

EXPERIMENTAL

Subject will receive two sprays (200 mcg per day)of FP into each nostril once daily (OD) every morning for 14 days

Drug: FPNS

FPNS Placebo arm

PLACEBO COMPARATOR

Subject will receive two sprays of FP placebo into each nostril OD every morning for 14 days

Drug: FPNS Placebo

Cetirizine arm

EXPERIMENTAL

Subject will receive Cetirizine capsule by mouth OD in the morning for 14 days

Drug: Cetirizine

Cetirizine Placebo arm

PLACEBO COMPARATOR

Subject will receive Cetirizine Placebo capsule by mouth OD in the morning for 14 days

Drug: Cetirizine Placebo

Interventions

FPNS DRUG

Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray.

FPNS arm

FPNS Placebo DRUG

Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays.

FPNS Placebo arm

Cetirizine DRUG

Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle).

Cetirizine arm

Cetirizine Placebo DRUG

Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).

Cetirizine Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent: Subject must give their signed and dated written informed consent to participate. Subject must understand and be willing, able, and likely to comply with study procedures and restrictions. Subject must be able to read, comprehend, and record information in English.
• Subject is treatable on an outpatient basis.
• Age: \>=18 years of age at Visit 1.
• Gender: Male or eligible female subjects. A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. OR Childbearing potential with a negative pregnancy test at screening and agreeable to using one of the acceptable contraceptive methods consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study). An eligible female is also not lactating nor planning on becoming pregnant during the study.
• Diagnosis of SAR, defined as documented clinical history or physician verification of subject reported historical SAR during each of the last two fall allergy seasons and a positive skin prick test (wheal \>=3 millimeter \[mm\] larger than the negative control) to a prevalent local fall allergen within 12 months prior to Visit 1 or at Visit 1.
• Adequate exposure to local fall pollen: Subject resides within a geographical region where exposure to the local fall pollen to which they are sensitized is expected to be moderate or greater during the study period. Subject does not plan to travel outside the geographical region where exposure to local fall pollen to which they are sensitized is expected to be moderate or greater for more than 48 hours during the study period.
• At Visit 2, the subject must meet the following criteria
• Eligible subjects will need to have moderate to severe SAR symptoms, defined as a morning rTNSS of \>=7 on at least four of the last seven days leading up to randomization. This includes the AM assessment on the morning of the randomization visit at Visit 2.
• Subjects should demonstrate at least a 70% compliance rate with both their placebo run-in study medications and their e-diary completion prior to randomization. This period includes the day of Visit 1 until the day before randomization at Visit 2.

You may not qualify if:

• Subjects should not have travelled outside the local pollen region for more than 48 hours during the run-in period.
• Significant concomitant medical conditions, defined as but not limited to:
• Historical or current evidence of a clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema, uncontrolled asthma). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
• A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug.
• Nasal (e.g., nasal septum), ocular, or throat injury, or surgery to these areas in the last 3 months.
• Rhinitis medicamentosa. Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period.
• Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator.
• Current or history of glaucoma and/or cataracts or ocular herpes simplex. Physical impairment that would affect subject's ability to safely and fully participate in the study.
• Clinical evidence of a Candida infection of the nose. History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results.
• History of adrenal insufficiency.
• Use of corticosteroids, defined as: Intranasal corticosteroid within four weeks prior to Visit 1 and during the treatment period. Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1 and during the treatment period.
• Leukotriene modifiers (\<=3 days from Visit 1). Oral antihistamines (\<=2 days from Visit 1). Allergy medications, other than study supplied medications, are not allowed during the study.
• Use of other medications that may affect allergic rhinitis or its symptoms, e.g., use of any ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening and treatment periods
• Use of any medications (prescription or non-prescription) or alcohol to induce sleep 48-hours prior to Visit 1 and during the treatment period.
• Use of other intranasally administered medications (e.g., calcitonin), including herbals and homeopathics during the run-in (Visit 1 - Visit 2) and treatment period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (31)

GSK Investigational Site

Little Rock, Arkansas, 72205, United States

Location

GSK Investigational Site

Denver, Colorado, 80230, United States

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46208, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66215, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66210, United States

Location

GSK Investigational Site

Owensboro, Kentucky, 42301, United States

Location

GSK Investigational Site

Baltimore, Maryland, 21236, United States

Location

GSK Investigational Site

Bethesda, Maryland, 20814, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55402, United States

Location

GSK Investigational Site

Columbia, Missouri, 65203, United States

Location

GSK Investigational Site

Rolla, Missouri, 65401, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Bellevue, Nebraska, 68123-4303, United States

Location

GSK Investigational Site

Canton, Ohio, 44718, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15212, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29118, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Austin, Texas, 78731, United States

Location

GSK Investigational Site

Austin, Texas, 78750, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Kerrville, Texas, 78028, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Waco, Texas, 76712, United States

Location

GSK Investigational Site

South Burlington, Vermont, 05403, United States

Location

GSK Investigational Site

Greenfield, Wisconsin, 53228, United States

Location

Related Publications (1)

• Ford LB, Matz J, Hankinson T, Prillaman B, Georges G. A comparison of fluticasone propionate nasal spray and cetirizine in ragweed fall seasonal allergic rhinitis. Allergy Asthma Proc. 2015 Jul-Aug;36(4):313-9. doi: 10.2500/aap.2015.36.3860.

  PMID: 26108088 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic, Seasonal

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 17, 2013
• Last Updated: June 20, 2018
• Results First Posted: August 27, 2014

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (31)