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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
  Purpose
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge

Condition Intervention Phase
Rhinitis
Drug: Placebo
Drug: SB-705498
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ] [ Designated as safety issue: Yes ]
  • Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ] [ Designated as safety issue: Yes ]
  • Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours following dosing ] [ Designated as safety issue: No ]
  • Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin [ Time Frame: 0-4hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Intranasal, single dose SB-705498 plasma PK parameters-Cmax [ Time Frame: 0-4hours ] [ Designated as safety issue: No ]
  • Intranasal, single dose SB-705498 plasma PK parameters- Tmax [ Time Frame: 0-4hours post dosing ] [ Designated as safety issue: No ]
  • Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t) [ Time Frame: 0-4hours post dosing ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with nasal examination data [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with abnormal ECG findings [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Body temperature [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with abnormal hematology values [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with abnormal clinical chemistry values- Creatinine [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
3 incremental capsaicin doses
Drug: Placebo
SB-705498 placebo
Active Comparator: Arm 2
3 incremental capsaicin doses
Drug: SB-705498
12mg intranasal SB-705498

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01439308

Locations
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111925
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01439308     History of Changes
Other Study ID Numbers: 111925 
Study First Received: August 25, 2011
Last Updated: November 30, 2016
Health Authority: Netherlands: De Centrale Commissie Mensgebonden Onderzoek
Individual Participant Data  
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.

Keywords provided by GlaxoSmithKline:
NAR
Capsaicin challenge

Additional relevant MeSH terms:
Rhinitis
Common Cold
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016