A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00464568
First received: April 20, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic range.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
SAR
Drug: GSK256066
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomised, Open, Placebo-controlled 5-way Crossover Trial of Single Doses of Intranasal GSK256066 in Subjects With Seasonal Allergic Rhinitis (SAR).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Effects of GSK256066 on ribonucleic acid (RNA) levels, which show phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples

Secondary Outcome Measures:
  • To explore the safety, tolerability and pharmacokinetics of single doses of GSK256066 in mild to moderate allergic rhinitic subjects. To explore the effects of GSK256066 on additional markers of PDE4 inhibition in nasal lavage.

Enrollment: 32
Study Start Date: March 2007
Study Completion Date: May 2007
Intervention Details:
    Drug: GSK256066
    Other Name: GSK256066
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is healthy.
  • Body mass index less than 29.0 kg/m² , weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
  • They have a history of hayfever (repeated yearly episodes).
  • They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
  • They have a positive radioallergosorbent test for grass pollen at or within the 12 months preceding the screening visit.
  • non-smokers.
  • They must have a baseline FEV1>80% predicted and a baseline FEV1(maximum recorded value)/ forced vital capacity (FVC) (maximum recorded value)>70%
  • They are capable of giving informed consent
  • They are available to complete all study measurements.

Exclusion Criteria:

  • Pregnant or nursing females.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
  • The subject has structural nasal abnormalities or nasal polyposis.
  • Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
  • The subject has a history of drug or other allergy that may contraindicate participation.
  • The subject has participated in a study with a new molecular entity during the previous 4 months or in any clinical study in the previous 3 months
  • The subject is concurrently participating in another clinical study and is exposed to an investigational or a non-investigational drug or device.
  • The subject has a screening QTc value >450msec, PR interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements.In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia.
  • The subject has a supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
  • The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study.
  • The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, and herbal remedies (e.g. St. John's Wort). Paracetamol (<2g/day) and occasional as needed use of short-acting beta agonists is permitted.
  • Past or present disease which may affect study. outcome
  • The subject regularly, or on average, drinks more than 4 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
  • The subject is at risk of non-compliance with the study procedures/restrictions.
  • The subject has Hepatitis B, Hepatitis C, or HIV virus.
  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: NCT00464568

Locations
Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00464568     History of Changes
Other Study ID Numbers: IPR109764
Study First Received: April 20, 2007
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Seasonal allergic rhinitis,
hayfever

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 24, 2014