Rhinitis, Allergic, PerennialPhase 1NCT00404586
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
A Phase 1 study testing GW784568X and Fluticasone propionate in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- GW784568X and Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2006to 16 Jan 2007
- Phase
- Phase 1
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy with exception of seasonal rhinitis. May also have mild asthma.
- Weight greater than or equal to 50kg
- Non-smoker for at least 12 months
Who cannot join
- History of frequent nosebleeds
- Have participated in another trial in the last 30 days.
- Have donated blood in the previous 3 months
- Have used prescription or non prescription drugs within last 7 days
- Have history of alcohol/drug abuse within last 12 months
- Have positive Hepatitis B or C test within 3 months of screening
- Subject tested positive for HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled, 4-period, Incomplete Block, Crossover Study of 7 Days Dosing of Intranasal GW784568X (100mcg, 200mcg and 400mcg od), Fluticasone Propionate (200mcg od) and Placebo (Blinded for GW784568X vs Placebo) to Evaluate the Efficacy and Safety Using an Environmental Chamber in Male Subjects With Allergic Rhinitis
This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis
Read the detailed description
A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- GW784568X, Fluticasone propionate, Placebo
- Keywords
- Environmental Challenge Chamber, GW784568X, Intranasal
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW784568XDrug
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Fluticasone propionateDrug
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
PlaceboDrug
Matching Placebo to GW784568X as aqueous nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. Receives: Drug: GW784568X; Drug: Fluticasone propionate |
| Treatment period 2 | Experimental | In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. Receives: Drug: GW784568X; Drug: Fluticasone propionate |
| Treatment period 3 | Experimental | In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. Receives: Drug: GW784568X; Drug: Fluticasone propionate |
| Treatment period 4 | Placebo comparator | In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. Receives: Drug: Fluticasone propionate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal symptom scores after 7 days of dosing
Measured: after 7 days of dosing
Secondary outcomes (1)
Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
Measured: on Day 7 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study start11 Sep 2006
- Primary completion16 Jan 2007
- Study completion16 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404586
- Sponsor's protocol ID
- BGS105049
- Status last verified
- Sep 2017
- First submitted
- 27 Nov 2006
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, 4-period, Incomplete Block, Crossover Study of 7 Days Dosing of Intranasal GW784568X (100mcg, 200mcg and 400mcg od), Fluticasone Propionate (200mcg od) and Placebo (Blinded for GW784568X vs Placebo) to Evaluate the Efficacy and Safety Using an Environmental Chamber in Male Subjects With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00404586
- Acronym / sponsor ID
- BGS105049
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Environmental Challenge Chamber, GW784568X, Intranasal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2006 (actual)
- Primary completion
- 16 Jan 2007 (actual)
- Study completion
- 16 Jan 2007 (actual)
- First posted
- 29 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis
Detailed description
A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: GW784568X, Drug: Fluticasone propionateIn treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 2 | Experimental | Drug: GW784568X, Drug: Fluticasone propionateIn treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 3 | Experimental | Drug: GW784568X, Drug: Fluticasone propionateIn treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
| Treatment period 4 | Placebo comparator | Drug: Fluticasone propionate, Drug: PlaceboIn treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy with exception of seasonal rhinitis. May also have mild asthma.
- Weight greater than or equal to 50kg
- Non-smoker for at least 12 months
Key exclusion criteria (7 listed)
- History of frequent nosebleeds
- Have participated in another trial in the last 30 days.
- Have donated blood in the previous 3 months
- Have used prescription or non prescription drugs within last 7 days
- Have history of alcohol/drug abuse within last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW784568XGW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg. | Drug | Treatment period 1, Treatment period 2, Treatment period 3 |
| Fluticasone propionateFluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg. | Drug | Treatment period 1, Treatment period 2, Treatment period 3, Treatment period 4 |
| PlaceboMatching Placebo to GW784568X as aqueous nasal spray. | Drug | Treatment period 4 |
Primary outcome
Nasal symptom scores after 7 days of dosing
Time frame: after 7 days of dosing
1 secondary outcome
Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
Time frame: on Day 7 and Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Results for study BGS105049 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW784568X and Fluticasone propionate in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site in Germany.
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 3 inclusion and 7 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 12 Sep 2017. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Nasal symptom scores after 7 days of dosing (time frame: after 7 days of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.