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RhinitisPhase 2NCT01439308

Intranasal SB-705498 in Non-allergic Rhinitis Patients

A Phase 2 study testing SB-705498 in people with Rhinitis, run by GlaxoSmithKline at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Rhinitis
What is being tested?
SB-705498
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteNetherlands
Study dates
Dec 2009to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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)).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • GSK Investigational Site

    Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

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

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

Conditions
Rhinitis
Being tested
Placebo, SB-705498
Keywords
NAR, Capsaicin challenge
Medical subject headings
Rhinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    SB-705498 placebo

  • SB-705498Drug

    12mg intranasal SB-705498

Study groups in NCT01439308
Study groupRoleWhat they receive
Arm 1Placebo comparator3 incremental capsaicin doses
Receives: Drug: Placebo
Arm 2Active comparator3 incremental capsaicin doses
Receives: Drug: SB-705498

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 0-4hours following dosing

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

    Measured: 0-4hours following dosing

Secondary outcomes (17)

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

    Measured: 0-4hours following dosing

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

    Measured: 0-4hours following dosing

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

    Measured: 0-4hours

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

    Measured: 0-4hours following dosing

  5. Intranasal, single dose SB-705498 plasma PK parameters-Cmax

    Measured: 0-4hours

  6. Intranasal, single dose SB-705498 plasma PK parameters- Tmax

    Measured: 0-4hours post dosing

  7. Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t)

    Measured: 0-4hours post dosing

  8. Number of participants with adverse events

    Measured: Day 1

  9. Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP)

    Measured: Day 1

  10. Heart rate

    Measured: Day 1

  11. Number of participants with nasal examination data

    Measured: Day 1

  12. Number of participants with abnormal ECG findings

    Measured: Day 1

  13. Body temperature

    Measured: Day 1

  14. Number of participants with abnormal hematology values

    Measured: Day 1

  15. Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides

    Measured: Day 1

  16. Number of participants with abnormal clinical chemistry values- Creatinine

    Measured: Day 1

  17. Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2011 (estimated)
  2. Study startDec 2009
  3. Primary completionApr 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439308
Sponsor's protocol ID
111925
Status last verified
Nov 2016
First submitted
25 Aug 2011
Last updated
1 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB-705498 in people with Rhinitis, run by GlaxoSmithKline at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin (time frame: 0-4hours following dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01439308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.

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