AsthmaPhase 1NCT00483899
Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects
A Phase 1 study testing GW870086X in people with Asthma, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Asthma
- What is being tested?
- GW870086X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 7 Oct 2005to 15 Dec 2006
- 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects aged 18-55
- Documented history of bronchial asthma diagnosed at least 6 months ago.
- Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
- Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
- Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit
Who cannot join
- Any significant illness or disease
- History of life threatening asthma
- History of respiratory tract infection
- Subjects who take medication for their asthma, or other conditions, not compatible with this study.
- Smoker
- Subjects who are oversensitive to corticosteroids
Show all 11Show fewer
- History of drug or alcohol abuse
- Donated blood within last 3 months
- Been involved in another clinical trial during the last 3 months
- Subjects who work night shifts
- Subjects who are undergoing de-sensitisation therapy
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
London, SE5 8AF
GSK Investigational Site
London
GSK Investigational Site
Manchester, Lancashire, M23 9LT
About this study
Official title: Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics
This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)
- Conditions
- Asthma
- Being tested
- GW870086X, Placebo
- Keywords
- GW870086X Asthma Crossover repeat dose inhaled
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW870086XDrug
Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times
PlaceboDrug
Placebo matching GW870086X will be administered by subjects
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Part A | Experimental | Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo. Receives: Drug: GW870086X; Drug: Placebo |
| Cohort 2: Part A | Experimental | Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo. Receives: Drug: GW870086X; Drug: Placebo |
| Part B | Experimental | Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo. Receives: Drug: GW870086X; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung function 2 hours after treatment on day 7
Measured: on day 7
Secondary outcomes (1)
Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs
Measured: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study start7 Oct 2005
- Primary completion15 Dec 2006
- Study completion15 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT00483899
- Sponsor's protocol ID
- SIG102335
- Status last verified
- Sep 2017
- First submitted
- 5 Jun 2007
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics
- ClinicalTrials.gov ID
- NCT00483899
- Acronym / sponsor ID
- SIG102335
- Conditions
- Asthma
- Keywords
- GW870086X Asthma Crossover repeat dose inhaled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2005 (actual)
- Primary completion
- 15 Dec 2006 (actual)
- Study completion
- 15 Dec 2006 (actual)
- First posted
- 7 Jun 2007 (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 repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A | Experimental | Drug: GW870086X, Drug: PlaceboSubjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo. |
| Cohort 2: Part A | Experimental | Drug: GW870086X, Drug: PlaceboSubjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo. |
| Part B | Experimental | Drug: GW870086X, Drug: PlaceboSubjects will be randomized to receive 1 and 3 mg of GW870086X or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged 18-55
- Documented history of bronchial asthma diagnosed at least 6 months ago.
- Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin
- Documented sensitivity to adenosine mono phosphate (AMP) at screening visit
- Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit
Key exclusion criteria (11 listed)
- Any significant illness or disease
- History of life threatening asthma
- History of respiratory tract infection
- Subjects who take medication for their asthma, or other conditions, not compatible with this study.
- Smoker
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 |
|---|---|---|
| GW870086XSubjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times | Drug | Cohort 1: Part A, Cohort 2: Part A, Part B |
| PlaceboPlacebo matching GW870086X will be administered by subjects | Drug | Cohort 1: Part A, Cohort 2: Part A, Part B |
Primary outcome
Change in lung function 2 hours after treatment on day 7
Time frame: on day 7
1 secondary outcome
Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs
Time frame: 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7;
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 29 Sep 2017.
- Results for study SIG102335 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
3 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 GW870086X in people with Asthma, run by GlaxoSmithKline at 3 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 5 inclusion and 11 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 29 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 3 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?
Change in lung function 2 hours after treatment on day 7 (time frame: on day 7). 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 29 Sep 2017.