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Intranasal SB-705498 in Non-allergic Rhinitis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01439308
First received: August 25, 2011
Last updated: November 30, 2016
Last verified: November 2016
August 25, 2011
November 30, 2016
December 2009
April 2010   (Final data collection date for primary outcome measure)
  • Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ]
  • Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ]
Symptom scores and ipsilateral secretion weights [ Time Frame: 0-4hours following dosing ]
Complete list of historical versions of study NCT01439308 on ClinicalTrials.gov Archive Site
  • Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ]
  • Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ]
  • Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours ]
  • Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ]
  • Intranasal, single dose SB-705498 plasma PK parameters-Cmax [ Time Frame: 0-4hours ]
  • Intranasal, single dose SB-705498 plasma PK parameters- Tmax [ Time Frame: 0-4hours post dosing ]
  • Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t) [ Time Frame: 0-4hours post dosing ]
  • Number of participants with adverse events [ Time Frame: Day 1 ]
  • Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Day 1 ]
  • Heart rate [ Time Frame: Day 1 ]
  • Number of participants with nasal examination data [ Time Frame: Day 1 ]
  • Number of participants with abnormal ECG findings [ Time Frame: Day 1 ]
  • Body temperature [ Time Frame: Day 1 ]
  • Number of participants with abnormal hematology values [ Time Frame: Day 1 ]
  • Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides [ Time Frame: Day 1 ]
  • Number of participants with abnormal clinical chemistry values- Creatinine [ Time Frame: Day 1 ]
  • Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase [ Time Frame: Day 1 ]
  • Peak nasal inspiratory flow changes after challenge [ Time Frame: 0-4hours following dosing ]
  • Biomarker levels in the nasal samples [ Time Frame: 0-4hours following dosing ]
  • Blood levels of drug [ Time Frame: 0-4hours following dosing ]
  • Number of subjects with adverse events [ Time Frame: Day 1 ]
  • Symptom scores and contralateral secretion weights [ Time Frame: 0-4hours following dosing ]
Not Provided
Not Provided
 
Intranasal SB-705498 in Non-allergic Rhinitis Patients
A Randomized, Double Blind, Placebo Controlled Study to Assessthe Effect of Intranasal Single Dose SB-705498 on the Response Tointranasal Capsaicin Challenge in Non-allergic Rhinitis Patients
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rhinitis
  • Drug: Placebo
    SB-705498 placebo
  • Drug: SB-705498
    12mg intranasal SB-705498
  • Placebo Comparator: Arm 1
    3 incremental capsaicin doses
    Intervention: Drug: Placebo
  • Active Comparator: Arm 2
    3 incremental capsaicin doses
    Intervention: Drug: SB-705498
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • NAR patients
  • Male or female between 18 and 60 years of age inclusive.
  • Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
  • Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
  • Body weight > 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).
  • Capable of giving written informed consent.
  • Available to complete all the required study measurements.
  • Normal 12-lead ECG at screening.
  • Subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.
  • Normal levels of total plasma IgG and negative allergy skin or Rast test to common aeorallergens.
  • Good general health, apart from NAR, as determined by a responsible physician.

Exclusion Criteria:

Past medical history of allergic rhinitis or rhinosinusitis.

  • Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
  • A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
  • Positive pre-study drug/alcohol screen.
  • Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
  • History of regular alcohol consumption within 6 months of the study.
  • Exposure to more than four new chemical entities within 12 months prior to the start of the study.
  • Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study.
  • Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
  • Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
  • History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
  • Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
  • Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this study.
  • Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • For Part 2 only: Subjects with known lactose intolerance.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01439308
111925
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP