AsthmaPhase 1NCT00273013
Study With GW274150 In Patients With Mild Asthma
A Phase 1 study testing GW274150 and Singulair in people with Asthma, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW274150 and Singulair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Nov 2004to 28 Oct 2005
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild asthma: taking reliever medication (e.g. salbutamol) only.
- Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.
Who cannot join
- Recent steroid treatment.
- Significant illnesses or diseases other than asthma.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
London, SE1 9RT
GSK Investigational Site
Manchester, Lancashire, M23 9LT
About this study
Official title: Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects
This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.
- Conditions
- Asthma
- Being tested
- GW274150, Singulair, Placebo
- Keywords
- asthma, allergen challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW274150Drug
GW274150 will be available as 30 mg white oval tablets.
SingulairDrug
Also called GW274150
Singulair will be available as over encapsulated 10 mg orange tablets.
PlaceboDrug
Matching placebo for Singulair and GW274150 will be available.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
| Sequence 2 | Experimental | Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
| Sequence 3 | Experimental | Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
| Sequence 4 | Experimental | Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
| Sequence 5 | Experimental | Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
| Sequence 6 | Experimental | Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3. Receives: Drug: GW274150; Drug: Singulair; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on the late asthmatic reaction following an inhaled allergen challenge
Measured: Up to Day 115
Secondary outcomes (1)
Measures of safety. Measures of lung function
Measured: Up to Day 115
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study start15 Nov 2004
- Primary completion28 Oct 2005
- Study completion28 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 28 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
- NCT00273013
- Sponsor's protocol ID
- INO102141
- Status last verified
- Oct 2017
- First submitted
- 4 Jan 2006
- Last updated
- 18 Oct 2017
- Results posted
- No
Publications
Singh D, Richards D, Knowles RG, Schwartz S, Woodcock A, Langley S, O'Connor BJ. Selective inducible nitric oxide synthase inhibition has no effect on allergen challenge in asthma. Am J Respir Crit Care Med. 2007 Nov 15;176(10):988-93. doi: 10.1164/rccm.200704-588OC. Epub 2007 Aug 23.
PubMed 17717202
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects
- ClinicalTrials.gov ID
- NCT00273013
- Acronym / sponsor ID
- INO102141
- Conditions
- Asthma
- Keywords
- asthma, allergen challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2004 (actual)
- Primary completion
- 28 Oct 2005 (actual)
- Study completion
- 28 Oct 2005 (actual)
- First posted
- 9 Jan 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 is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3. |
| Sequence 2 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3. |
| Sequence 3 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3. |
| Sequence 4 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3. |
| Sequence 5 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3. |
| Sequence 6 | Experimental | Drug: GW274150, Drug: Singulair, Drug: PlaceboSubjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Mild asthma: taking reliever medication (e.g. salbutamol) only.
- Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study.
Key exclusion criteria (2 listed)
- Recent steroid treatment.
- Significant illnesses or diseases other than asthma.
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 |
|---|---|---|
| GW274150GW274150 will be available as 30 mg white oval tablets. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| SingulairAlso: GW274150Singulair will be available as over encapsulated 10 mg orange tablets. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| PlaceboMatching placebo for Singulair and GW274150 will be available. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Effect on the late asthmatic reaction following an inhaled allergen challenge
Time frame: Up to Day 115
1 secondary outcome
Measures of safety. Measures of lung function
Time frame: Up to Day 115
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 18 Oct 2017.
- Derived from this study: PubMed 17717202Singh D, Richards D, Knowles RG, Schwartz S, Woodcock A, Langley S, O'Connor BJ. Selective inducible nitric oxide synthase inhibition has no effect on allergen challenge in asthma. Am J Respir Crit Care Med. 2007 Nov 15;176(10):988-93. doi: 10.1164/rccm.200704-588OC. Epub 2007 Aug 23.
- Results for study 102141 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW274150 and Singulair in people with Asthma, run by GlaxoSmithKline at 2 sites in United Kingdom.
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 2 inclusion and 2 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 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?
Effect on the late asthmatic reaction following an inhaled allergen challenge (time frame: Up to Day 115). 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 NCT00273013, 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 18 Oct 2017.