BronchospasmPhase 1NCT00400660
A First Time In Human Study To Assess The Compound GSK615915
A Phase 1 study testing GSK615915A in people with Bronchospasm, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchospasm
- What is being tested?
- GSK615915A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Nov 2005to 3 Jul 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
- Women of non-child bearing potential.
- 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
- The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.
- The subject has demonstrated the ability to correctly use a metered dose inhaler device.
- If asthmatic:
- The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.
Who cannot join
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
- The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.
- The subject has recently participated in another clinical trial.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days.
- The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- Any history of breathing problems (e.g. history of asthmatic symptoms).
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- The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
- The subject is has a positive drugs of abuse test.
- The subject has had a respiratory tract infection within 4 weeks of the start of the study.
- The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study.
- The subject has a history of life-threatening asthma.
- 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 has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit.
- The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit.
- The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation.
- The subject has ongoing rhinitis that requires treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Edinburgh, West Lothian, EH14 4AP
About this study
Official title: First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
- Conditions
- Bronchospasm
- Being tested
- GSK615915A, Placebo
- Keywords
- GSK615915 asthma surfactant MDI
- Medical subject headings
- Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK615915ADrug
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
PlaceboDrug
Subjects will also receive placebo inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence 1: Part 1 | Experimental | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. Receives: Drug: GSK615915A; Drug: Placebo |
| Subjects receiving treatment sequence 2: Part 1 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. Receives: Drug: GSK615915A; Drug: Placebo |
| Subjects receiving treatment sequence 1: Part 2 | Experimental | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. Receives: Drug: GSK615915A; Drug: Placebo |
| Subjects receiving treatment sequence 2: Part 2 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. Receives: Drug: GSK615915A; Drug: Placebo |
| Subjects receiving GSK615915A: Part 3 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms. Receives: Drug: GSK615915A |
| Subjects receiving placebo: Part 3 | Experimental | Eligible subjects will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
Measured: Up to 18 weeks
Secondary outcomes (1)
Levels of GSK615915A and any breakdown products in the blood and urine.
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study start23 Nov 2005
- Primary completion3 Jul 2006
- Study completion3 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchospasmStudies 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
- 46 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
- NCT00400660
- Sponsor's protocol ID
- OLA103920
- Status last verified
- Sep 2017
- First submitted
- 15 Nov 2006
- Last updated
- 29 Sep 2017
- Results posted
- 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
- First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915
- ClinicalTrials.gov ID
- NCT00400660
- Acronym / sponsor ID
- OLA103920
- Conditions
- Bronchospasm
- Keywords
- GSK615915 asthma surfactant MDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2005 (actual)
- Primary completion
- 3 Jul 2006 (actual)
- Study completion
- 3 Jul 2006 (actual)
- First posted
- 17 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.
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
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: GSK615915A, Drug: PlaceboEligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving treatment sequence 2: Part 1 | Experimental | Drug: GSK615915A, Drug: PlaceboEligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
| Subjects receiving treatment sequence 1: Part 2 | Experimental | Drug: GSK615915A, Drug: PlaceboEligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving treatment sequence 2: Part 2 | Experimental | Drug: GSK615915A, Drug: PlaceboEligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
| Subjects receiving GSK615915A: Part 3 | Experimental | Drug: GSK615915AEligible subjects will receive GSK615915A with a starting dose of 250 micrograms. |
| Subjects receiving placebo: Part 3 | Experimental | Drug: PlaceboEligible subjects will receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women of non-child bearing potential.
- 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
- The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.
- The subject has demonstrated the ability to correctly use a metered dose inhaler device.
- If asthmatic:
Key exclusion criteria (16 listed)
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
- The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.
- The subject has recently participated in another clinical trial.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days.
- The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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 |
|---|---|---|
| GSK615915AGSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler. | Drug | Subjects receiving GSK615915A: 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 |
| PlaceboSubjects will also receive placebo inhaler. | 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
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
Time frame: Up to 18 weeks
1 secondary outcome
Levels of GSK615915A and any breakdown products in the blood and urine.
Time frame: Up to 18 weeks
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 OLA103920 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 GSK615915A in people with Bronchospasm, 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 16 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 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 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?
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG) (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.