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Pulmonary Disease, Chronic ObstructivePhase 2NCT00676052

Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing GSK233705 12.5mcg, GSK233705 25mcg and GSK233705 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 88 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
GSK233705 12.5mcg, GSK233705 25mcg and GSK233705 50mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
576 participants
Where
88 sitesin 14 countries
Study dates
16 May 2008to 22 Dec 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A signed and dated written informed consent prior to study participation.
  • Male or female adults.
  • A female is eligible to enter and participate in this study if she is of:
  • non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact)
  • 40 to 80 years of age at Visit 1
  • An established clinical history of COPD
  • Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1.
  • A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Women who are pregnant or lactating.
  • A current diagnosis of asthma.
  • Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
  • Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy)
  • Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD.
Show all 26Show fewer
  • Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1.
  • Hospitalization for COPD or pneumonia within 3 months prior to Visit 1.
  • Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1.
  • Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities.
  • An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem.
  • Positive for Hepatitis B or Hepatitis C at Visit 1.
  • A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1
  • A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate.
  • Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric.
  • Medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after Visit 3).
  • Additional Medications: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit 1.
  • Use of long-term oxygen therapy (LTOT) or supplemental oxygen required for greater than 12 hours a day. Oxygen use as needed is not exclusionary.
  • Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP)
  • Use of regular nebulized therapy
  • Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV)
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
  • An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study
  • History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
  • Use of GSK233705B in previous studies.

Trial locations and contacts

88 sites in 14 countries.

88 sites in 14 countries

United States25 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Glendale, Arizona, 85306

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Lafayette, Louisiana, 70503

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    South Miami, Florida, 33143

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

Germany13 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10559

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 14057

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Wiesloch, Baden-Wurttemberg, 69168

Other trials in Germany

Canada8 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N1

  • GSK Investigational Site

    Mississauga, Ontario, L5A 3V4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    Sainte Jerome, Quebec, J7Z 5T3

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

Other trials in Canada

Argentina5 sites

  • GSK Investigational Site

    La Plata, Buenos Aires, CP1900

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, 7600

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Pergamino, Buenos Aires, 2700

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Chile5 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500691

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

South Africa5 sites

  • GSK Investigational Site

    Bellville, 7531

  • GSK Investigational Site

    Cape Town, Gauteng, 7505

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Mueckelneck, Gauteng, 0001

  • GSK Investigational Site

    Parktown, Gauteng, 2193

Other trials in South Africa

Bulgaria4 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia

Other trials in Bulgaria

Hungary4 sites

  • GSK Investigational Site

    Balassagyarmat, 2660

  • GSK Investigational Site

    Budapest, 1095

  • GSK Investigational Site

    Budapest, H-1529

  • GSK Investigational Site

    Mátraháza, 3233

Other trials in Hungary

Netherlands4 sites

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Hoofddorp, 2134 TM

  • GSK Investigational Site

    Hoorn, 1624 NP

Other trials in Netherlands

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Songkhla, 90110

Other trials in Thailand

Philippines3 sites

  • GSK Investigational Site

    Cavite, 4114

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1109

Other trials in Philippines

Romania3 sites

  • GSK Investigational Site

    Brasov, 500112

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Iași, 700115

Other trials in Romania

United Kingdom3 sites

  • GSK Investigational Site

    Brighton, Sussex East, BN2 5BE

  • GSK Investigational Site

    London, SE5 9PJ

  • GSK Investigational Site

    Norwich, NR4 7UY

Other trials in United Kingdom

South Korea2 sites

  • GSK Investigational Site

    Seoul, 133--792

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

About this study

Official title: Multicentre Dose Ranging Study for Once Daily GSK233705 in COPD

The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.

Being tested
GSK233705 12.5mcg, GSK233705 25mcg, GSK233705 50mcg, GSK233705 100mcg, GSK233705 200mcg
Keywords
COPD, Multicenter, GSK233705B, double-blind, Chronic Obstructive Pulmonary Disease (COPD), randomized
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.

  • GSK233705 12.5mcgDrug

    Once daily via dry powder inhaler

  • GSK233705 25mcgDrug

    once daily via dry powder inhaler

  • GSK233705 50mcgDrug

    Once daily via dry powder inhaler

  • GSK233705 100mcgDrug

    Once daily via dry powder inhaler

  • GSK233705 200mcgDrug

    Once daily via dry powder inhaler

  • PlaceboDrug

    Once daily via dry powder imhaler

Study groups in NCT00676052
Study groupRoleWhat they receive
Arm 1ExperimentalGSK233705 12.5mcg
Receives: Drug: GSK233705 12.5mcg
Arm 2ExperimentalGSK233705 25mcg
Receives: Drug: GSK233705 25mcg
Arm 3ExperimentalGSK233705 50mcg
Receives: Drug: GSK233705 50mcg
Arm 4ExperimentalGSK233705 100mcg
Receives: Drug: GSK233705 100mcg
Arm 5ExperimentalGSK233705 200mcg
Receives: Drug: GSK233705 200mcg
Arm 6Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29

    The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.

    Measured: Baseline (pre-dose Day 1) and Day 29

Secondary outcomes (3)

  1. Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29

    Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.

    Measured: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29

  2. Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29

    Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.

    Measured: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29

  3. Change From Baseline in Clinic Visit Trough FVC on Day 29

    The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.

    Measured: Baseline (pre-dose Day 1) and Day 29

Timeline

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

  1. First posted12 May 2008 (estimated)
  2. Study start16 May 2008
  3. Primary completion22 Dec 2008
  4. Study completion22 Dec 2008

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676052
Sponsor's protocol ID
AC2110664
Status last verified
Aug 2017
First submitted
8 May 2008
Last updated
9 Oct 2017
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

  • Bateman E, Feldman G, Kilbride S, Brooks J, Mehta R, Harris S, Maden C, Crater G. Efficacy and safety of the long-acting muscarinic antagonist GSK233705 delivered once daily in patients with COPD. Clin Respir J. 2012 Oct;6(4):248-57. doi: 10.1111/j.1752-699X.2011.00278.x. Epub 2012 Feb 13.

    PubMed 22329914

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK233705 12.5mcg, GSK233705 25mcg and GSK233705 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 88 sites in 14 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 8 inclusion and 26 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Germany, Canada, Argentina, Chile and 9 more countries. 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 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?

Yes. Results are posted in the registry (first posted 7 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 (time frame: Baseline (pre-dose Day 1) and Day 29). 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 NCT00676052, 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 9 Oct 2017.

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