Pulmonary Disease, Chronic ObstructivePhase 1NCT00364273
GSK159802 In Healthy Male Subjects And Asthmatics
A Phase 1 study testing GSK159802 and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK159802 and Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 24 Aug 2005to 6 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index within the range 18.5-29.9 (kg/m2)
- Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.
- Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients):
- Subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease
- Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted.
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of > or equal to 12.0% over baseline and an absolute change of > or equal to 300 mL within 30 minutes following 400 mcg salbutamol.
Who cannot join
- Any clinically relevant abnormality
- Subjects who have a screening haemoglobin values < 11 g/dL
- The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days
- Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
London
GSK Investigational Site
Manchester, Lancashire, M23 9LT
About this study
Official title: A Randomised, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.
The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK159802, Placebo, Salmeterol
- Keywords
- Asthma
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK159802Drug
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
PlaceboDrug
Subjects will receive placebo administered using DISKUS inhaler.
SalmeterolDrug
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment sequence 1 : Cohort 1 | Experimental | Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 2 : Cohort 1 | Experimental | Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 3 : Cohort 1 | Experimental | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 4 : Cohort 1 | Experimental | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 5 : Cohort 1 | Experimental | Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 1 : Cohort 2 | Experimental | Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD). Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 2 : Cohort 2 | Experimental | Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 3 : Cohort 2 | Experimental | Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 4 : Cohort 2 | Experimental | Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 1 : Cohort 3 | Experimental | Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 2 : Cohort 3 | Experimental | Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 3 : Cohort 3 | Experimental | Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 4 : Cohort 3 | Experimental | Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
| Subjects receiving treatment sequence 5 : Cohort 3 | Experimental | Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo. Receives: Drug: GSK159802; Drug: Placebo; Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability of single inhaled doses of GSK159802.
Measured: Up to 71 days
Secondary outcomes (1)
sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure
Measured: Up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study start24 Aug 2005
- Primary completion6 Jul 2006
- Study completion6 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Single group
- Enrolment
- 43 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
- NCT00364273
- Sponsor's protocol ID
- B2F104300
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2006
- Last updated
- 29 Sep 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.
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, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00364273
- Acronym / sponsor ID
- B2F104300
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2005 (actual)
- Primary completion
- 6 Jul 2006 (actual)
- Study completion
- 6 Jul 2006 (actual)
- First posted
- 15 Aug 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.
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.
The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment sequence 1 : Cohort 1 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 2 : Cohort 1 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 3 : Cohort 1 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 4 : Cohort 1 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 5 : Cohort 1 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo. |
| Subjects receiving treatment sequence 1 : Cohort 2 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD). |
| Subjects receiving treatment sequence 2 : Cohort 2 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD. |
| Subjects receiving treatment sequence 3 : Cohort 2 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol. |
| Subjects receiving treatment sequence 4 : Cohort 2 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo. |
| Subjects receiving treatment sequence 1 : Cohort 3 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms. |
| Subjects receiving treatment sequence 2 : Cohort 3 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms. |
| Subjects receiving treatment sequence 3 : Cohort 3 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol. |
| Subjects receiving treatment sequence 4 : Cohort 3 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo. |
| Subjects receiving treatment sequence 5 : Cohort 3 | Experimental | Drug: GSK159802, Drug: Placebo, Drug: SalmeterolEligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index within the range 18.5-29.9 (kg/m2)
- Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.
- Subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease
- Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted.
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of > or equal to 12.0% over baseline and an absolute change of > or equal to 300 mL within 30 minutes following 400 mcg salbutamol.
Key exclusion criteria (4 listed)
- Any clinically relevant abnormality
- Subjects who have a screening haemoglobin values < 11 g/dL
- The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days
- Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
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 |
|---|---|---|
| GSK159802GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler. | Drug | Subjects receiving treatment sequence 1 : Cohort 1, Subjects receiving treatment sequence 1 : Cohort 2, Subjects receiving treatment sequence 1 : Cohort 3, Subjects receiving treatment sequence 2 : Cohort 1, Subjects receiving treatment sequence 2 : Cohort 2, Subjects receiving treatment sequence 2 : Cohort 3, Subjects receiving treatment sequence 3 : Cohort 1, Subjects receiving treatment sequence 3 : Cohort 2, Subjects receiving treatment sequence 3 : Cohort 3, Subjects receiving treatment sequence 4 : Cohort 1, Subjects receiving treatment sequence 4 : Cohort 2, Subjects receiving treatment sequence 4 : Cohort 3, Subjects receiving treatment sequence 5 : Cohort 1, Subjects receiving treatment sequence 5 : Cohort 3 |
| PlaceboSubjects will receive placebo administered using DISKUS inhaler. | Drug | Subjects receiving treatment sequence 1 : Cohort 1, Subjects receiving treatment sequence 1 : Cohort 2, Subjects receiving treatment sequence 1 : Cohort 3, Subjects receiving treatment sequence 2 : Cohort 1, Subjects receiving treatment sequence 2 : Cohort 2, Subjects receiving treatment sequence 2 : Cohort 3, Subjects receiving treatment sequence 3 : Cohort 1, Subjects receiving treatment sequence 3 : Cohort 2, Subjects receiving treatment sequence 3 : Cohort 3, Subjects receiving treatment sequence 4 : Cohort 1, Subjects receiving treatment sequence 4 : Cohort 2, Subjects receiving treatment sequence 4 : Cohort 3, Subjects receiving treatment sequence 5 : Cohort 1, Subjects receiving treatment sequence 5 : Cohort 3 |
| SalmeterolSalmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler. | Drug | Subjects receiving treatment sequence 1 : Cohort 1, Subjects receiving treatment sequence 1 : Cohort 2, Subjects receiving treatment sequence 1 : Cohort 3, Subjects receiving treatment sequence 2 : Cohort 1, Subjects receiving treatment sequence 2 : Cohort 2, Subjects receiving treatment sequence 2 : Cohort 3, Subjects receiving treatment sequence 3 : Cohort 1, Subjects receiving treatment sequence 3 : Cohort 2, Subjects receiving treatment sequence 3 : Cohort 3, Subjects receiving treatment sequence 4 : Cohort 1, Subjects receiving treatment sequence 4 : Cohort 2, Subjects receiving treatment sequence 4 : Cohort 3, Subjects receiving treatment sequence 5 : Cohort 1, Subjects receiving treatment sequence 5 : Cohort 3 |
Primary outcome
Safety & tolerability of single inhaled doses of GSK159802.
Time frame: Up to 71 days
1 secondary outcome
sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure
Time frame: Up to 71 days
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 B2F104300 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
- 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
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 GSK159802 and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, 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 6 inclusion and 4 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 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?
Safety & tolerability of single inhaled doses of GSK159802. (time frame: Up to 71 days). 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.