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Pulmonary Disease, Chronic ObstructivePhase 1NCT00279019

Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease

A Phase 1 study testing GSK233705 and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 and Tiotropium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
3 sitesGermany
Study dates
12 Dec 2005to 13 Jun 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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Of non-childbearing potential.
  • Diagnosed with COPD, as defined by the GOLD guidelines.
  • Smoker or an ex-smoker with a smoking history of at least 10 pack years.
  • FEV1/FVC < 0.7 post-bronchodilator (salbutamol).
  • FEV1 <= 80% of predicted normal for height, age and gender after inhalation of salbutamol.
  • Response to ipratropium bromide 9.
  • Subject's weight is 60kg.

Who cannot join

  • Past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
  • FEV1 <=50% of predicted after inhalation of salbutamol.
  • Tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
  • Has claustrophobia that may be aggravated by entering the plethysmography cabinet.
  • Has prostate hypertrophy or narrow angle glaucoma.
  • Diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, or asthma.
Show all 22Show fewer
  • Poorly controlled COPD.
  • Participated in a Pulmonary Rehabilitation Program within 4 weeks prior to screening visit or will enter a program during the study.
  • Had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
  • History of congestive heart failure, coronary insufficiency or cardiac arrhythmia.
  • A mean QTc(B) value at screening >440msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120-210msec or an ECG that is not suitable for QT measurements.
  • A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg.
  • A mean heart rate outside the range 40-90 bpm.
  • QTc prolongation >470msec or risk factors for torsades de pointes (heart failure NYHA II-IV, hypokalaemia, familial long QT syndrome).
  • Receiving co-medication with drugs which prolong the QTc interval.
  • Requires treatment with inhaled cromolyn sodium or nedocromil, oral beta-2-agonists, nebulised beta-2-agonists, nebulised anticholinergics or leukotriene modifiers.
  • Unable to abstain from xanthines (other than caffeine.
  • Unable to abstain from short-acting inhaled bronchodilators.
  • Unable to abstain from long-acting inhaled bronchodilators.
  • Changed dose of inhaled or oral corticosteroids within the last 6 weeks.
  • Taking more than 10mg/day of prednisolone (or equivalent).
  • Receiving treatment with long term or short-term oxygen therapy or requires nocturnal positive pressure for sleep apnea.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • GSK Investigational Site

    Berlin, 14050

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: A Randomised, Double Blind, Placebo-controlled, Double Dummy, 4-way Cross-over, Dose Ascending Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Inhaled Doses of GSK233705 and Tiotropium Bromide (18µg) Via DPI in COPD Patients

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.

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.

Being tested
GSK233705, Tiotropium, Placebo
Keywords
GSK233705, Chronic Obstructive Pulmonary Disease (COPD), COPD
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

    GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.

  • TiotropiumDrug

    Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.

  • PlaceboDrug

    Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose

Study groups in NCT00279019
Study groupRoleWhat they receive
Subjects receiving treatment sequence 1ExperimentalEligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 2ExperimentalEligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 3ExperimentalEligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 4ExperimentalEligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 5ExperimentalEligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 6ExperimentalEligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 7ExperimentalEligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 8ExperimentalEligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 9ExperimentalEligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 10ExperimentalEligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 11ExperimentalEligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 12ExperimentalEligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 13ExperimentalEligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 14ExperimentalEligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 15ExperimentalEligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo
Subjects receiving treatment sequence 16ExperimentalEligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo.
Receives: Drug: GSK233705; Drug: Tiotropium; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, ECG, lung function and clinical laboratory safety tests.

    Measured: Up to Week 12

Secondary outcomes (1)

  1. Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters. Serial IOS and FEV1 measurements over 27 hours post-dose Serial sGaw, Raw measurements over 24 hours post-dose.

    Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours Post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study start12 Dec 2005
  3. Primary completion13 Jun 2006
  4. Study completion13 Jun 2006

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279019
Sponsor's protocol ID
AC2103473
Status last verified
Sep 2017
First submitted
17 Jan 2006
Last updated
25 Sep 2017
Results posted
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK233705 and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in Germany.

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 7 inclusion and 22 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 25 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 3 sites in Germany. 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?

Adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, ECG, lung function and clinical laboratory safety tests. (time frame: Up to Week 12). 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 NCT00279019.

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 25 Sep 2017.

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