AsthmaPhase 1NCT00453791
The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
A Phase 1 study testing GW805858 in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GW805858
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2006to 10 Apr 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
- Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
- The subject is a current non-smoker who has not used any tobacco products in the last year.
- A signed and dated written informed consent is obtained for the subject.
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
- If asthmatic, the subject must be a clinically stable asthmatic.
Who cannot join
- The subject has a history of allergy to ingredients within the inhaler.
- The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
- The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female.
- The subject has any history of breathing problems (e.g. history of asthmatic symptoms).
- The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
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- The subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study.
- The subject has a past or present disease, which as judged by the Investigator, may affect the outcome of this study.
- The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures.
- The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
- The subject is unable to abstain from other drugs that may interfere with the conduct of the study.
- The subject has ongoing rhinitis that requires treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.
- Conditions
- Asthma
- Being tested
- GW805858, Placebo
- Keywords
- GW805858, MDI, asthma, surfactant
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW805858Drug
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
PlaceboDrug
Placebo MDI will be given to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence 1: Part 1 | Experimental | Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI). Receives: Drug: GW805858; Drug: Placebo |
| Subjects receiving treatment sequence 2: Part 1 | Experimental | Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI. Receives: Drug: GW805858; Drug: Placebo |
| Subjects receiving treatment sequence 1: Part 2 | Experimental | Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI. Receives: Drug: GW805858; Drug: Placebo |
| Subjects receiving treatment sequence 2: Part 2 | Experimental | Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI. Receives: Drug: GW805858; Drug: Placebo |
| Subjects receiving GW805858: Part 3 | Experimental | Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI. Receives: Drug: GW805858 |
| Subjects receiving placebo: Part 3 | Experimental | Eligible subjects will receive placebo administered using MDI. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.
Measured: Up to 18 weeks
Secondary outcomes (1)
Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.
Measured: Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study start7 Feb 2006
- Primary completion10 Apr 2006
- Study completion10 Apr 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
- Enrolment
- 31 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
- NCT00453791
- Sponsor's protocol ID
- SF2105450
- Status last verified
- Sep 2017
- First submitted
- 27 Mar 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
- A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
- ClinicalTrials.gov ID
- NCT00453791
- Acronym / sponsor ID
- SF2105450
- Conditions
- Asthma
- Keywords
- GW805858, MDI, asthma, surfactant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2006 (actual)
- Primary completion
- 10 Apr 2006 (actual)
- Study completion
- 10 Apr 2006 (actual)
- First posted
- 29 Mar 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 will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence 1: Part 1 | Experimental | Drug: GW805858, Drug: PlaceboEligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI). |
| Subjects receiving treatment sequence 2: Part 1 | Experimental | Drug: GW805858, Drug: PlaceboEligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI. |
| Subjects receiving treatment sequence 1: Part 2 | Experimental | Drug: GW805858, Drug: PlaceboEligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI. |
| Subjects receiving treatment sequence 2: Part 2 | Experimental | Drug: GW805858, Drug: PlaceboEligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI. |
| Subjects receiving GW805858: Part 3 | Experimental | Drug: GW805858Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI. |
| Subjects receiving placebo: Part 3 | Experimental | Drug: PlaceboEligible subjects will receive placebo administered using MDI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
- Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
- The subject is a current non-smoker who has not used any tobacco products in the last year.
- A signed and dated written informed consent is obtained for the subject.
- The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
Key exclusion criteria (12 listed)
- The subject has a history of allergy to ingredients within the inhaler.
- The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
- The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female.
- The subject has any history of breathing problems (e.g. history of asthmatic symptoms).
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 |
|---|---|---|
| GW805858GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve. | Drug | Subjects receiving GW805858: Part 3, Subjects receiving treatment sequence 1: Part 1, Subjects receiving treatment sequence 1: Part 2, Subjects receiving treatment sequence 2: Part 1, Subjects receiving treatment sequence 2: Part 2 |
| PlaceboPlacebo MDI will be given to the subjects. | Drug | Subjects receiving placebo: Part 3, Subjects receiving treatment sequence 1: Part 1, Subjects receiving treatment sequence 1: Part 2, Subjects receiving treatment sequence 2: Part 1, Subjects receiving treatment sequence 2: Part 2 |
Primary outcome
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.
Time frame: Up to 18 weeks
1 secondary outcome
Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.
Time frame: Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Results for study SF2105450 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 GW805858 in people with Asthma, run by GlaxoSmithKline at 1 site 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 6 inclusion and 12 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: stopped early, 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 1 site 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 was stopped early. Results are not available in the source record.
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?
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed. (time frame: Up to 18 weeks). 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.