AsthmaPhase 1NCT00444509
Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
A Phase 1 study testing GW685698X and GW685698X containing magnesium stearate in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
Trial summary
This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW685698X and GW685698X containing magnesium stearate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 Feb 2007to 9 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
- screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max of the three screening measures and an absolute change of
- >or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
- BMI 19-31 kg/m2,
- Non-smoker,
- refrains from use of prohibited medication within the specified timeframes
Who cannot join
- Pregnant or nursing females
- History of life threatening asthma
- Subjects who are unable to stop taking protocol defined prohibited medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.
- Conditions
- Asthma
- Being tested
- GW685698X, GW685698X containing magnesium stearate
- Keywords
- Asthmatic Patients
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW685698XDrug
GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
GW685698X containing magnesium stearateDrug
GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. Receives: Drug: GW685698X; Drug: GW685698X containing magnesium stearate |
| Treatment 2 | Experimental | Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. Receives: Drug: GW685698X; Drug: GW685698X containing magnesium stearate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days
Measured: Vital signs: for 48 hours
Secondary outcomes (1)
Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1.
Measured: following single inhaled doses in mild/moderate asthmatic patients for 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study start17 Feb 2007
- Primary completion9 Apr 2007
- Study completion9 Apr 2007
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
- 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
- NCT00444509
- Sponsor's protocol ID
- HZA108799
- Status last verified
- Aug 2017
- First submitted
- 6 Mar 2007
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00444509
- Acronym / sponsor ID
- HZA108799
- Conditions
- Asthma
- Keywords
- Asthmatic Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2007 (actual)
- Primary completion
- 9 Apr 2007 (actual)
- Study completion
- 9 Apr 2007 (actual)
- First posted
- 7 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 is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Drug: GW685698X, Drug: GW685698X containing magnesium stearateSubjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
| Treatment 2 | Experimental | Drug: GW685698X, Drug: GW685698X containing magnesium stearateSubjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
- screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of >or= 12.0% over the max of the three screening measures and an absolute change of
- >or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
- BMI 19-31 kg/m2,
- Non-smoker,
Key exclusion criteria (3 listed)
- Pregnant or nursing females
- History of life threatening asthma
- Subjects who are unable to stop taking protocol defined prohibited medication
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 |
|---|---|---|
| GW685698XGW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS | Drug | Treatment 1, Treatment 2 |
| GW685698X containing magnesium stearateGW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS | Drug | Treatment 1, Treatment 2 |
Primary outcome
Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days
Time frame: Vital signs: for 48 hours
1 secondary outcome
Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1.
Time frame: following single inhaled doses in mild/moderate asthmatic patients for 48 hours.
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 4 Aug 2017.
- BackgroundThis study has not been published in the scientific literature.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study HZA108799 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GW685698X and GW685698X containing magnesium stearate in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
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 3 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 4 Aug 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 New Zealand. 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?
Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days (time frame: Vital signs: for 48 hours). 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 NCT00444509, 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 4 Aug 2017.