Pulmonary Disease, Chronic ObstructivePhase 2NCT00376714
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing GSK233705 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial summary
GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK233705 when administered via inhalation in animal models supports the potential for use as a once-daily… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK233705
- How many people
- 45 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Aug 2006to 3 Apr 2007
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects must be of non-childbearing potential including pre-menopausal females
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females
- Subject diagnosed with COPD, as defined by the GOLD guidelines
- Body weight greater than 50kg
- Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
- Subject has FEV1/FVC < 0.7 post-bronchodilator (salbutamol).
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- Subject has FEV1 greater than or equal to 80% of predicted normal for height, age and gender after inhalation of 200 µg salbutamol.
- Response to ipratropium bromide defined as:
- Either: An increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 ug of ipratropium bromide at the screening visit
- or: a documented increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 ug of ipratropium bromide within 6 months of screening and an increase in FEV1 of >6% and >100ml 2h following inhalation of 80 ug of ipratropium bromide at the screening visit (in order to allow for potential fluctuations in the response to ipratropium bromide in patients known to be responders to ipratropium bromide).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subject is available to complete all study measurements and procedures.
Who cannot join
- Subjects who have a past or present disease, judged by the Investigator and the Medical Monitor, to affect the outcome of this study.
- The subject has a positive urine drug/ urine alcohol screen.
- History of alcohol/drug abuse or dependence within 12 months of the study:
- The subject has a positive pregnancy test.
- Subject has FEV1 greater than or equal to 40% of predicted after inhalation of salbutamol.
- A positive Hepatitis B or Hepatitis C result within 3 months of screening
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- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
- The subject has donated a unit of blood within 30 days of screening, or, intends to donate during the study.
- Subject has claustrophobia that may be aggravated by entering the plethysmography cabinet.
- The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of its derivatives or milk protein/lactose.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- Subject is unable to use the DISKUS™ device correctly.
- Subject has prostate hypertrophy or narrow angle glaucoma.
- Use of prescription drugs (with the exception of those allowed in the protocol) and herbal remedies (e.g. St John's Wort) within 48 hours of each treatment period
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
GSK Investigational Site
Antwerp, 2060
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
Sweden2 sites
GSK Investigational Site
Gothenburg, SE-413 45
GSK Investigational Site
Lund, SE-221 85
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 3 Period Crossover Study To Examine The Safety, Tolerability, Pharmacodynamics And Pharmacokinetics Of Repeat Inhaled Doses Of GSK233705B In COPD Subjects.
GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK233705 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK233705
- Keywords
- plethysmography, muscarinic receptor antagonist, COPD, repeat dosing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK233705Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.
Secondary outcomes (1)
Forced Expiratory Volume in 1 second (FEV1) Serial specific airways conductance (sGaw), airways resistance (Raw) Rescue medication usage Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study start16 Aug 2006
- Study completion3 Apr 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 45 participants
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
- NCT00376714
- Sponsor's protocol ID
- AC2105333
- Status last verified
- Jun 2018
- First submitted
- 13 Sep 2006
- Last updated
- 7 Jun 2018
- 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 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 3 Period Crossover Study To Examine The Safety, Tolerability, Pharmacodynamics And Pharmacokinetics Of Repeat Inhaled Doses Of GSK233705B In COPD Subjects.
- ClinicalTrials.gov ID
- NCT00376714
- Acronym / sponsor ID
- AC2105333
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- plethysmography, muscarinic receptor antagonist, COPD, repeat dosing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2006
- Study completion
- 3 Apr 2007 (actual)
- First posted
- 15 Sep 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.
GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK233705 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female subjects must be of non-childbearing potential including pre-menopausal females
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females
- Subject diagnosed with COPD, as defined by the GOLD guidelines
- Body weight greater than 50kg
- Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
Key exclusion criteria (16 listed)
- Subjects who have a past or present disease, judged by the Investigator and the Medical Monitor, to affect the outcome of this study.
- The subject has a positive urine drug/ urine alcohol screen.
- History of alcohol/drug abuse or dependence within 12 months of the study:
- The subject has a positive pregnancy test.
- Subject has FEV1 greater than or equal to 40% of predicted after inhalation of salbutamol.
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 |
|---|---|---|
| GSK233705 | Drug | – |
Primary outcome
Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.
1 secondary outcome
Forced Expiratory Volume in 1 second (FEV1) Serial specific airways conductance (sGaw), airways resistance (Raw) Rescue medication usage Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters
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 7 Jun 2018.
- 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
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK233705 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in 2 countries.
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 12 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.. 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 7 Jun 2018.