AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 4NCT00424528

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing Arformoterol Tartrate Inhalation Solution, Tiotropium and Arformoterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease and Bronchitis, run by Sumitomo Pharma America, Inc. at 28 sites in United States.

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 and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Arformoterol Tartrate Inhalation Solution, Tiotropium and Arformoterol and Tiotropium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
28 sitesUnited States
Study dates
Dec 2006to Oct 2007
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects must be at least 45 years old at the time of consent.
  • Subjects must have a pre-established primary clinical diagnosis of COPD.
  • Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
  • Subjects must have a FEV1 ≥ 0.70L at Visit 1.

Who cannot join

  • Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
  • Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Columbus, Ohio, 43215

  • Study site

    DeFuniak Springs, Florida, 32435

  • Study site

    DeLand, Florida, 32720

  • Study site

    East Providence, Rhode Island, 02914

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Jasper, Alabama, 35501

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    Lincoln, Rhode Island, 02865

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Marrero, Louisiana, 70072

  • Study site

    Medford, Oregon, 97504

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Portland, Oregon, 97213

  • Study site

    Saint Charles, Missouri, 63301

  • Study site

    San Diego, California, 92120

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Sunset, Louisiana, 70584

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Tucson, Arizona, 85715

Other trials in United States

About this study

Official title: A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Read the detailed description

This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Being tested
Arformoterol Tartrate Inhalation Solution, Tiotropium, Arformoterol and Tiotropium, Placebo
Keywords
COPD including chronic bronchitis and emphysema
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Bronchitis, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arformoterol Tartrate Inhalation SolutionDrug

    Also called Brovana®

    Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.

  • TiotropiumDrug

    Also called Spiriva

    Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.

  • Arformoterol and TiotropiumDrug

    Also called Brovana, Spiriva

    Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.

  • PlaceboDrug

    Placebo inhalation solution and placebo inhalation powder

Study groups in NCT00424528
Study groupRoleWhat they receive
Arformoterol 15 mcg twice dailyActive comparatorArformoterol 15 mcg twice daily/Placebo Inhalation Powder
Receives: Drug: Arformoterol Tartrate Inhalation Solution; Drug: Placebo
Tiotropium 18 mcg once dailyActive comparatorTiotropium 18 mcg once daily/Placebo Inhalation Solution
Receives: Drug: Tiotropium; Drug: Placebo
Arformoterol /TiotropiumExperimentalArformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
Receives: Drug: Arformoterol and Tiotropium

What is being measured

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

  1. Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)

    Measured: 24 hours following two weeks of dosing.

Secondary outcomes (15)

  1. Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)

    Measured: 0-12 hours following two weeks of dosing

  2. Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)

    Measured: Following 2 weeks of dosing

  3. Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)

    Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1.

    Measured: Following 2 weeks of dosing

  4. Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

    Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1.

    Measured: 2 weeks

  5. Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication

    Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted.

    Measured: 2 weeks

  6. Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline

    12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment.

    Measured: 2 weeks

  7. Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks

    Analyzed from end of dosing to 12 hours.

    Measured: 2 weeks

  8. Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks

    Analyzed from end of dosing to 12 hours.

    Measured: 2 weeks

  9. Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing

    Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC.

    Measured: 2 weeks

  10. Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint

    Measured: 2 Weeks

  11. Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week

    Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol.

    Measured: 2 weeks

  12. Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day

    Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period.

    Measured: 2 weeks

  13. Transition Dyspnea Index (TDI) Focal Score

    TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement.

    Measured: 2 weeks

  14. Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score

    A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.

    Measured: 2 weeks

  15. Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score

    A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important.

    Measured: 2 weeks

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 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424528
Sponsor's protocol ID
091-902
Status last verified
May 2012
First submitted
17 Jan 2007
Last updated
4 Jun 2012
Data monitoring committee
No

Publications

  • Tashkin DP, Donohue JF, Mahler DA, Huang H, Goodwin E, Schaefer K, Hanrahan JP, Andrews WT. Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. Respir Med. 2009 Apr;103(4):516-24. doi: 10.1016/j.rmed.2008.12.014. Epub 2009 Feb 8.

    PubMed 19208459

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Arformoterol Tartrate Inhalation Solution, Tiotropium and Arformoterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease and Bronchitis, run by Sumitomo Pharma America, Inc. at 28 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 2 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 2 Apr 2009). 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?

Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B) (time frame: 24 hours following two weeks of dosing.). 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 NCT00424528, 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 4 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in