Intranasal SB-705498 in Non-allergic Rhinitis Patients

NCT01439308 | Completed Phase 2

• 1 other identifier: 111925
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinitis

Keywords

NAR; Capsaicin challenge

Outcome Measures

Primary Outcomes (2)

• Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours following dosing

• Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours following dosing

Secondary Outcomes (17)

• Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours following dosing

• Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours following dosing

• Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours

• Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin

  0-4hours following dosing

• Intranasal, single dose SB-705498 plasma PK parameters-Cmax

  0-4hours

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

3 incremental capsaicin doses

Drug: Placebo

Arm 2

ACTIVE COMPARATOR

3 incremental capsaicin doses

Drug: SB-705498

Interventions

Placebo DRUG

SB-705498 placebo

Arm 1

SB-705498 DRUG

12mg intranasal SB-705498

Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

Related Links

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MeSH Terms

Conditions

Rhinitis

Interventions

SB 705498

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 25, 2011
• First Posted: September 23, 2011
• Study Start: December 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)