AsthmaPhase 1NCT01424280
Single Dose Study of GSK1440115 in Patients With Asthma
A Phase 1 study testing 1440115 in people with Asthma, run by Accenture at 1 site in Australia.
Trial summary
The purpose of this study is to assess bronchodilator effect after single dose administration of GSK1440115 in a population of mild to moderate asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- 1440115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2011to Nov 2011
- 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
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Male or female between 18 and 65 years of age, inclusive, at the time of signing informed consent.
- Male patients with a female partner of childbearing potential must have had a prior vasectomy or agree to use adequate contraception from the time of the first dose of study drug until three months after the last dose of study drug.
- A female patient is eligible to participate if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods defined in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
- Child-bearing potential, has a negative serum pregnancy test during the Screening Period, and agrees to use adequate contraception from Screening until four weeks after the last dose of study drug.
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- BMI within the range of 19-32 kg/m2 (inclusive).
- Documented history of bronchial asthma that is British Thoracic Society guideline step 1-3, diagnosed at least 3 months prior to the Screening visit.
- Patient should be on a fixed regimen for at least 4 weeks prior to Screening. The following asthma medications are permitted: i. Inhaled corticosteroid (ICS) per day use: <=800mcg of Beclomethasone Dipropionate or budesonide, 320mcg ciclesonide or 500mcg of Fluticasone propionate - or equivalent doses.
- Intermittent short-acting inhaled beta-2 agonist therapy (SABA). A minimum of 8 hours washout from SABA is required prior to Screening or study methacholine challenge tests or FEV1 assessments.
- Long-acting inhaled beta-2 agonist (LABA) therapy is not permitted during the study. If deemed appropriate by the investigator, patients usually managed with LABA can be switched to SABA in order to comply with requirements for washout. A minimum of 24 hour washout after last dose of LABA is required prior to Screening methacholine challenge tests or FEV1 assessments.
- Therapy with montelukast is allowed provided that administration is separated by at least 12 hours from study drug dosing (see Section 9).
- Best FEV1 of >70% predicted normal value during Screening.
- Hyper-responsive to methacholine such that a baseline methacholine PC20 is <= 4 mg/mL.
- Increase in PC20 of at least 2 dilutions compared to baseline in the presence of inhaled beta-agonist in response to a methacholine challenge.
- Patients who are currently non-smokers or who have not used any inhaled tobacco products in the previous 6 months prior to first dose of study drug.
- Average QTcF < 450 msec; or QTc < 480 msec in patients with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- A positive test for HIV antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study defined as:
- History of regular alcohol intake (average weekly intake of > 21 units males or >14 units females - One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits and 100 mL of wine.
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- History of chronic medical disease that in the investigators opinion may affect the outcome of the study - including interpretation of safety data. This may include, but is not limited to, malignancy, cardiovascular, hepatic, renal, hematological, neurological, thyroid disease, endocrine disease, or, other pulmonary diseases. Examples of specific exclusions include:
- History of heart attack or stroke within past 3 months.
- Presence of known aortic aneurysm.
- Epilepsy.
- COPD, pulmonary fibrosis, or bronchiectasis
- Peptic ulcer disease.
- Urinary tract obstruction.
- Clinically significant laboratory abnormalities at Screening.
- History of uncontrolled hypertension or persistent SBP>140 mmHg or DBP >90mmHg at Screening.
- History of life-threatening asthma (asthma episode requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizure) OR the following:
- Respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the first dose of study drug.
- Asthma exacerbation requiring hospitalization within 3 months prior to Screening.
- Administration of systemic steroids within 4 weeks of Screening.
- Intake of an investigational product within either 30 days or 5 half lives (whichever is longer) prior to first dose of study drug.
- History of sensitivity to any of the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Lactating females.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to Screening.
- Current use of a prohibited medication or requires use of a prohibited medication during study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo Controlled, Crossover Study to Evaluate the Efficacy of GSK1440115 After a Single Oral Dose in Patients With Asthma
The purpose of this study is to assess bronchodilator effect after single dose administration of GSK1440115 in a population of mild to moderate asthmatic patients.
- Conditions
- Asthma
- Being tested
- 1440115, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1440115Drug
Single dose of either 750 mg or 500 mg administered as 250 mg tablets.
PlaceboDrug
Single dose of matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Active drug | Experimental | Not described Receives: Drug: 1440115 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PC20
Measured: 7 hours post dose
Secondary outcomes (1)
Change from baseline in FEV1
Measured: 1, 2, 3, 4, 5, 6, and 7 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accenture
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424280
- Sponsor's protocol ID
- UR2115642
- Status last verified
- Dec 2011
- First submitted
- 1 Aug 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo Controlled, Crossover Study to Evaluate the Efficacy of GSK1440115 After a Single Oral Dose in Patients With Asthma
- ClinicalTrials.gov ID
- NCT01424280
- Acronym / sponsor ID
- UR2115642
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AccentureIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- First posted
- 26 Aug 2011 (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.
The purpose of this study is to assess bronchodilator effect after single dose administration of GSK1440115 in a population of mild to moderate asthmatic patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active drug | Experimental | Drug: 1440115 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Male or female between 18 and 65 years of age, inclusive, at the time of signing informed consent.
- Male patients with a female partner of childbearing potential must have had a prior vasectomy or agree to use adequate contraception from the time of the first dose of study drug until three months after the last dose of study drug.
- A female patient is eligible to participate if she is of:
- BMI within the range of 19-32 kg/m2 (inclusive).
Key exclusion criteria (25 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- A positive test for HIV antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study defined as:
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 |
|---|---|---|
| 1440115Single dose of either 750 mg or 500 mg administered as 250 mg tablets. | Drug | Active drug |
| PlaceboSingle dose of matching placebo tablets | Drug | Placebo |
Primary outcome
Methacholine PC20
Time frame: 7 hours post dose
1 secondary outcome
Change from baseline in FEV1
Time frame: 1, 2, 3, 4, 5, 6, and 7 hours post dose
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 2 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 1440115 in people with Asthma, run by Accenture at 1 site in Australia.
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 18 inclusion and 25 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 2 Dec 2011. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Methacholine PC20 (time frame: 7 hours post dose). 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 2 Dec 2011.