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Pulmonary Disease, Chronic ObstructivePhase 4ADC111114NCT00784550

A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

A Phase 4 study testing Tiotropium Bromide and Fluticasone Propionate/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in United States.

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

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD. Read more about this study

Who is it for?
Ages 40 to 99 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium Bromide and Fluticasone Propionate/Salmeterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
35 sitesUnited States
Study dates
Dec 2008to Dec 2009
Phase
Phase 4
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • COPD diagnosis
  • At least 10 pack year smoking history
  • Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
  • An FEV1/FVC ratio of less than or equal to 0.70

Who cannot join

  • Current diagnosis of asthma
  • Other respiratory disorder other than COPD
  • Abnormal and clinical significant ECG
  • Chest x-ray clinically significant abnormality not believed to be due to COPD
  • Body Mass Index of greater than or equal to 40/kg/m2
  • Use of Long Term Oxygen Therapy
Show all 9Show fewer
  • Lung resection surgery
  • Women pregnant or lactating at Visit 1
  • Previously diagnosed cancer unless in complete remission for 2 years at Visit 1

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Cumberland, Rhode Island, 02864

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Elizabeth City, North Carolina, 27909

  • GSK Investigational Site

    Elkhart, Indiana, 46514

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Fort Collins, Colorado, 80528

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Gillespie, Illinois, 62033

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77054

  • GSK Investigational Site

    Louisville, Kentucky, 40207

  • GSK Investigational Site

    Milan, Tennessee, 38358

  • GSK Investigational Site

    Mooresville, North Carolina, 28117

  • GSK Investigational Site

    Naranja, Florida, 33032

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Olathe, Kansas, 66061

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Plano, Texas, 75024

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Being tested
Tiotropium Bromide, Fluticasone Propionate/Salmeterol
Keywords
Spirometry, 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.

  • Tiotropium BromideDrug

    Long-acting muscarinic antagonist

  • Fluticasone Propionate/SalmeterolDrug

    Inhaled corticosteroid plus long-acting bronchodilator

Study groups in NCT00784550
Study groupRoleWhat they receive
ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhalerExperimentalFluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD
Receives: Drug: Fluticasone Propionate/Salmeterol
SPIRIVA® HANDIHALER® inhalerActive comparatorTiotropium Bromide 18mcg QD plus Placebo DISKUS BID
Receives: Drug: Tiotropium Bromide

What is being measured

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

  1. Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint

    Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.

    Measured: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)

Secondary outcomes (5)

  1. Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint

    Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.

    Measured: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)

  2. Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint

    Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.

    Measured: Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)

  3. Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint

    Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).

    Measured: Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)

  4. Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint

    Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.

    Measured: Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)

  5. Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint

    The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.

    Measured: Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)

Timeline

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

  1. First posted4 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00784550
Sponsor's protocol ID
111114
Acronym
ADC111114
Status last verified
Oct 2016
First submitted
31 Oct 2008
Last updated
23 Nov 2016
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

  • Hanania NA, Crater GD, Morris AN, Emmett AH, O'Dell DM, Niewoehner DE. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. Respir Med. 2012 Jan;106(1):91-101. doi: 10.1016/j.rmed.2011.09.002. Epub 2011 Oct 29.

    PubMed 22040533

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium Bromide and Fluticasone Propionate/Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in United States.

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 4 inclusion and 9 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Dec 2010). 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?

Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (time frame: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)). 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 NCT00784550, 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 23 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.

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