Intranasal SB-705498 in Allergic Rhinitis (AR) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424397
First received: August 18, 2011
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.


Condition Intervention Phase
Rhinitis
Drug: SB-705498
Drug: FP
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Incomplete Block, 3 Way Cross Over Study in Subjects With Allergic Rhinitis to Assess the Effect of Intranasal Repeat Doses of SB-705498 When Administered Alone or in Conjunction With Intranasal Fluticasone Propionate on the Symptoms of Rhinitis in the Vienna Allergen Challenge Chamber

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • TNSS scores D8 following allergen chamber challenge [ Time Frame: Day 8 of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Real life TNSS scores days 4-8 [ Time Frame: Days 4-8 of each treatment period ] [ Designated as safety issue: No ]
  • Active Anterior Rhinomanometry (AAR) changes from baseline to D8 [ Time Frame: Day 1 and Day 8 of each treatment period ] [ Designated as safety issue: No ]
  • Rhinoconjunctivitis Quality of Life Questionnaire changes from baseline to D8 [ Time Frame: Screening and Day 8 of each treatment period ] [ Designated as safety issue: No ]
  • Blood levels of drug following 8 days of dosing [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: Day 1 to Day 8 of each treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-705498
Experimental
Drug: SB-705498
12mg intranasal
Active Comparator: Flucticasone Propionate
Active Comparator
Drug: FP
200ug intranasal
Placebo Comparator: Placebo
Placebo Comparator
Drug: placebo
placebo intranasal
Experimental: SB-705498+FP
Experimental
Drug: SB-705498
12mg intranasal
Drug: FP
200ug intranasal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
  2. TNSS score of >=4 following screening allergen challenge chamber.
  3. Positive skin prick test for seasonal pollen
  4. Positive RAST for seasonal pollen
  5. Healthy as determined by responsible physician with the exception of mild asthma and AR
  6. Male or female between 18 and 65 years of age inclusive.
  7. A female subject is eligible to participate if she is of:

    • Non-childbearing potential defined as pre-menopausal females with a \documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory].
    • Child-bearing potential and agrees to use one of the contraception methods listed as instructed. Female subjects must agree to use contraception until 84 days post-last treatment administration.
  8. Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.
  9. Body weight ≥ 50 kg (males) and ≥45kg (females) and BMI within the range 19 - 29.9 kg/m2 (inclusive).
  10. Screening pre-challenge FEV1 greater than or equal to 80% and baselines FEV1/FVC greater than or equal to 70% of predicted value.
  11. Capable of giving written informed consent.
  12. Average QTcB, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
  13. AST and ALT < 2xULN; alkaline phosphatase and bilirubin less than or equal to 1.5xULN

Exclusion Criteria:

  1. Nasal abnormalities likely to affect the outcome of the study,
  2. History of frequent nosebleeds.
  3. Respiratory disease other than mild asthma
  4. A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
  5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  6. Positive pre-study drug/alcohol/smoking screen.
  7. A positive test for HIV antibody.
  8. History of regular alcohol consumption within 6 months of the study defined as:

    • An average weekly intake of >14 drinks for males or >7 drinks for females.

  9. The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product prior to D1.
  10. Exposure to more than four new chemical entities within 12 months prior to D1.
  11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
  12. History of sensitivity to any of the study medications, or components
  13. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  14. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
  15. Lactating females.
  16. Subject is mentally or legally incapacitated.
  17. Urine cotinine levels indicative of smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424397

Locations
Austria
GSK Investigational Site
Vienna, Austria, A-1150
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424397     History of Changes
Other Study ID Numbers: 111924
Study First Received: August 18, 2011
Last Updated: May 29, 2014
Health Authority: Austria: Bundesamt fur Sicherheit im Gesundheitswesen (BASG)

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 23, 2014