Intranasal SB-705498 in Non-allergic Rhinitis Patients

Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439308
• Other study ID #: 111925
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2011
• Last updated: November 30, 2016
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold
• Rhinitis

Intervention

Drug:
• Placebo
SB-705498 placebo
• SB-705498
12mg intranasal SB-705498

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin		0-4hours following dosing
Primary	Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin		0-4hours following dosing
Secondary	Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin		0-4hours following dosing
Secondary	Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin		0-4hours following dosing
Secondary	Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin		0-4hours
Secondary	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
Secondary	Intranasal, single dose SB-705498 plasma PK parameters-Cmax		0-4hours
Secondary	Intranasal, single dose SB-705498 plasma PK parameters- Tmax		0-4hours post dosing
Secondary	Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t)		0-4hours post dosing
Secondary	Number of participants with adverse events		Day 1
Secondary	Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP)		Day 1
Secondary	Heart rate		Day 1
Secondary	Number of participants with nasal examination data		Day 1
Secondary	Number of participants with abnormal ECG findings		Day 1
Secondary	Body temperature		Day 1
Secondary	Number of participants with abnormal hematology values		Day 1
Secondary	Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides		Day 1
Secondary	Number of participants with abnormal clinical chemistry values- Creatinine		Day 1
Secondary	Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase		Day 1

External Links

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