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Rhinitis, Allergic, SeasonalPhase 2NCT00612820

A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)

A Phase 2 study testing GSK256066 and fluticasone propionate in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Austria.

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 is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Rhinitis, Allergic, Seasonal
What is being tested?
GSK256066 and fluticasone propionate
How many people
55 participants
Where
1 siteAustria
Study dates
Jan 2008to May 2008
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
  • They aged 18 to 50 years inclusive.
  • Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
  • They have a history of seasonal allergic rhinitis.
  • They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom score of at least 6. (Nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which have been scored on a scale from 0 to 3).
  • They have a positive skin prick test (wheal ³ 4mm) for grass pollen at or within the 12 months preceding the screening visit.
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  • They have a positive RAST (³ class 2) for grass pollen at or within the 12 months preceding the screening visit.
  • They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit with a pack history of £ 10 pack years.
  • Pack years = No of cigarettes smoked/day
  • They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/FVC (maximum recorded value)>70% predicted (using the Standardized Lung Function Testing guidelines produced by European Community for Coal and Steel).
  • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 4 hours.
  • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
  • They are available to complete all study measurements.

Who cannot join

  • Pregnant or nursing females.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception, as outlined below, from at least two weeks prior to the first dose of study medication; and to continue until the final pregnancy test has been performed.
  • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2weeks) or ongoing upper respiratory tract infection which in the Responsible Physician's opinion renders the subject unsuitable for participation in the study.
  • 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 is likely to be unable to abstain from salbutamol use for 8 hours before a challenge.
  • The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
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  • The subject is concurrently participating in another clinical study or has participated in a study with an investigational product (new chemical entity) during the previous 4 months or in any clinical study during the previous month.
  • The subject has a screening QTc(B) value >450msec, PQ interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave). In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia.
  • A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
  • A supine mean heart rate outside the range 40-90 beats per minute (bpm) 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). Subjects are not permitted to take potent inhibitors of cytochrome P450 3A4 including macrolide antibiotics or azole anti-fungals due to potential for increased systemic exposure to fluticasone propionate. Paracetamol (£2g/day) and occasional as needed use of short-acting beta agonists is permitted.
  • The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (which ever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • The subject had used oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit.
  • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease*, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
  • subjects will require normal serum creatinine clearance values at screening [calculated from serum creatinine by a predicting equation using Cockcroft-Gualt formula]. If the creatinine clearance value is greater than the upper limit of normal as determined by the local laboratory reference range, the Investigator will determine whether this is a clinically significant finding that would preclude participation.
  • The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.
  • The subject is at risk of non-compliance with the study procedures/restrictions.
  • The subject is infected with the Hepatitis B, Hepatitis C, or HIV.
  • The subject has an elevated Troponin T above the normal range.
  • The subject has an elevated CK-MB above the normal range. Contraception for females
  • Appropriate contraceptive methods for female subjects include:
  • Abstinence. The lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication and to continue until the follow up visit.
  • One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository):
  • Documented tubal ligation
  • Documented placement of an intrauterine device (IUD) or intrauterine system (IUS)
  • Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • GSK Investigational Site

    Vienna, A-1150

Other trials in Austria

About this study

Official title: An 8 Day, Randomised, Double Blind, 3-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Fluticasone Propionate in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)

This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.

Being tested
GSK256066, fluticasone propionate
Keywords
Vienna Challenge Chamber, Seasonal Allergic Rhinitis,
Medical subject headings
Rhinitis, Allergic, Seasonal

What participants receive

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

  • GSK256066Drug

    200mcg bd,

  • fluticasone propionateDrug

    Also called GSK256066

    200mcg od,100mcg bd

What is being measured

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

  1. Investigate effect of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2.

    Measured: spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2.

Secondary outcomes (11)

  1. •Nasal symptoms

    Measured: provoked after Day 2 dose.

  2. •Nasal symptoms

    Measured: after Day 8 dose.

  3. Eye and global symptoms, nasal obstruction and secretions

    Measured: after Day 2 and 8 dose.

  4. Weighted mean TNSS (sneeze, itch, rhinorrhoea and obstruction)

    Measured: 1 to 4hours post morning dose period spent in the Vienna Challenge Chamber on Day 8.

  5. Weighted mean eye symptom score (watery eyes, itchy eyes, red eyes)

    Measured: over 1 to 4 hours on Day 2 and 8.

  6. Weighted mean global symptom score (sneeze, itch, rhinorrhoea, obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes and red eyes)

    Measured: over 1 to 4 hours on Day 2 and 8.

  7. Weighted mean nasal airflow resistance (measured using active anterior rhinomanometry) and secretion weight (measured by weighing tissues)

    Measured: over 1 to 4 hours on Day 2 and 8.

  8. Weighted mean components of TNSS (sneeze, itch, rhinorrhoea and obstruction)

    Measured: over 1 to 4 hours on Day 2 and 8.

  9. FEV1, ECGs, Vitals, AEs, and laboratory safety parameters.

  10. Effect of GSK256066 on ribonucleic acid (RNA) levels indicative of PDE4 inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples

  11. Effect of fluticasone propionate on RNA levels indicative of glucocorticoid-provoked gene expression in nasal scrape samples and on glucocorticoid receptor (GR) translocation in lavage samples

Timeline

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

  1. First posted12 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMay 2008
  4. Study completionMay 2008

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
Crossover
Masking
Double blind
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612820
Sponsor's protocol ID
IPR110723
Status last verified
Nov 2016
First submitted
29 Jan 2008
Last updated
3 Nov 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.

Publications

  • This study has not been published in the scientific literature.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK256066 and fluticasone propionate in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Austria.

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 13 inclusion and 27 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 3 Nov 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 Austria. 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. 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?

Investigate effect of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2. (time frame: spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2.). 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 NCT00612820, which also lists 1 linked publication.

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 3 Nov 2016.

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