AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4ESWTNCT01124422

Fluticasone Propionate/Salmeterol Combination 250/50 DISKUS in the Exercise Endurance Time in Patients With Chronic Obstructive Pulmonary Disease

A Phase 4 study testing fluticasone propionate/salmeterol inhalation powder DISKUS 250/50 and tiotropium bromide inhalation powder HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 27 sites in 2 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 objective of this study is to demonstrate that, when added to tiotropium (TIO), fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO alone. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
fluticasone propionate/salmeterol inhalation powder DISKUS 250/50 and tiotropium bromide inhalation powder HandiHaler
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
27 sitesin 2 countries
Study dates
19 Jul 2010to 2 May 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects eligible for enrolment in the study must meet all of the following criteria at V1.
  • Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation.
  • Age: at least 40 yr of age
  • Sex: Male or Female
  • Females are eligible to participate only if they are currently not pregnant and not lactating. In addition, female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A female is otherwise eligible to enter and participate in the study if she is of:
  • non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
Show all 21Show fewer
  • child-bearing potential, has a negative pregnancy test (urine) at screening, and is committed to the consistent and correct use of an acceptable method of birth control, starting at V2, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days), as defined by at least one of the following:
  • use of implants of levonorgestrel or etonogestrel
  • percutaneous contraceptive patches
  • use of injectable progestogen
  • use of oral contraceptive (either combined estrogen/progestin or progestin only)
  • use of any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per yr
  • male partner is sterile (vasectomy with documentation of azoospermia; note that a verbal report of azoospermia is acceptable) and is the sole sexual partner for that female subject prior to the female subject's entry into the study
  • double-barrier method; condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicide
  • abstinence: if not sexually active, must commit to complete abstinence from intercourse
  • Female subjects, with the exception of those who are post-menopausal or surgically sterile, will undergo urine pregnancy tests approximately 7 days prior to first dose and approximately monthly.
  • Diagnosis: An established clinical history of COPD in accordance with the definition of the American Thoracic Society (ATS).
  • Severity of Disease: FEV1 post-albuterol/salbutamol at least 30 to no more than 80% of predicted normal and FEV1/FVC ratio post-albuterol/salbutamol of no more than 0.70 based on NHANES III reference values. Note that identical formulations of short-acting beta-agonist are called albuterol in the US and salbutamol in Canada.
  • Smoking History: A history of smoking at least 10 pack-yr is required. Pack-yr are defined as the number of packs of cigarettes smoked per day multiplied by the number of yr smoked. Please note that both current and previous smokers are eligible for this study. Previous smoking is defined as no smoking for at least 6 months prior to consent; subjects are otherwise considered "current" smokers.
  • CXR: Chest radiograph, within 1 yr prior to consent, without findings suspected to represent an active, clinically-significant process other than those believed to be related to uncomplicated COPD.
  • Use of TIO: A history of using TIO with compliance at least 80% starting at least 14 days prior to V1, and ending 24 hr prior to V1, is required. Please note that any subject whose medical history precludes the safe use of TIO (such as significant narrow-angle glaucoma, known urinary retention, etc) should not be started on TIO for the purpose of this study.

Who cannot join

  • Subjects meeting any of the following criteria at V1 must not be enrolled in the study:
  • Asthma: A current diagnosis of asthma.
  • Other Diseases/Abnormalities: Any significant disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or which would affect the efficacy analysis if the disease/condition exacerbated during the study. Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 yr (no evidence of tumor burden) at V1. Localized carcinomas of the skin that have been resected for cure are not exclusionary.
  • Other Respiratory Disorders: Subject had lung resection surgery (e.g., lung volume reduction surgery or lobectomy) within 1 yr of V1 or has a significant respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, sleep apnea, cystic fibrosis, or alpha-1-antitrypsin deficiency) that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or which would affect the efficacy analysis if the disease/condition exacerbated during the study.
  • Acute Exacerbation of COPD: active disease within the past 6 wk. For the purpose of this study, an acute exacerbation of COPD will be identified using the following criteria [Anthonisen, 1987; Burge, 2003; Anzueto, 2009]: either
  • worsening of two or more of the following "major" symptoms for at least two consecutive days:
Show all 23Show fewer
  • dyspnea
  • sputum volume
  • sputum purulence or
  • worsening of any one major symptom together with any one of the following "minor" symptoms for at least two consecutive days:
  • sore throat
  • nasal discharge or nasal congestion
  • fever without other cause
  • increased cough or wheeze.
  • Pulmonary Rehabilitation: Participation in the early, active phase of a Pulmonary Rehabilitation Program. For the purpose of this study, the "early, active" phase of pulmonary rehabilitation consists of sessions, scheduled on a regular and frequent basis (generally more than bi-weekly and for a total duration of at least 4 wk), held at an institution or at home, that include exercise training among interventions such as education and psychosocial support. Not included as the "early, active" phase of pulmonary rehabilitation are reinforcement or maintenance sessions that follow an "early, active" phase with interactions that are less frequent and less intense but may be scheduled for a longer total duration such as 6 months to 1 yr.
  • 12-Lead ECG: Potential subjects are excluded if they have a functioning cardiac pacemaker. Otherwise, the investigator will determine the clinical significance of any ECG abnormality, and whether it precludes the potential subject from entering the study.
  • Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, corticosteroid (intranasal, inhaled, or systemic including any components of the formulations [e.g. lactose or milk protein]), or atropine or its derivatives, including ipratropium or tiotropium.
  • Body Mass Index (BMI): A BMI of 40 kg/m2 or higher.
  • Use of ritonavir, ketoconazole or other potent inhibitors of CYP3A4: If any of these medications are used prior to V1, they must be stopped at V1 if indicated.
  • Other Exclusionary medications: If any of the following medications are used prior to V1, they must be stopped as specified below.
  • (Medication, Washout period prior to V1) Any Investigational Drug, 30 days Oral or parenteral corticosteroids, 30 days ICS, 30 days ICS/LABA combination products (e.g., ADVAIR, Symbicort), 30 days Theophylline, 7 days Tiotropium, 24 hr LABA (e.g. formoterol or salmeterol), 12 hr Short-acting beta-agonists (e.g., albuterol or salbutamol), 6 hr Ipratropium or ipratropium-containing combination products (e.g., Combivent), 6 hr Oral beta-agonists, 6 hr
  • Long-Term Oxygen Therapy (LTOT): Subject is on LTOT and is receiving supplemental oxygen more frequently than nocturnal-only.
  • Affiliation with investigator site: Subject is a study Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator or immediate family member of the aforementioned.

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States18 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Fort Collins, Colorado, 80528

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hartford, Connecticut, 06105

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    The Woodlands, Texas, 77380

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    Webster, Texas, 77598

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • GSK Investigational Site

    Hamilton, Ontario, L9H 7S4

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 0W8

  • GSK Investigational Site

    Toronto, Ontario, M5T 3A9

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: A Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50 mcg Twice Daily Plus Tiotropium 18 mcg Daily Versus Placebo DISKUS Twice Daily Plus Tiotropium 18 mcg Daily on Exercise Time and Physiological Parameters in Subjects With Chronic Obstructive Pulmonary Disease

The objective of this study is to demonstrate that, when added to tiotropium (TIO), fluticasone propionate/salmeterol combination (FSC) DISKUS 250/50 significantly increases exercise endurance time (EET) in the endurance shuttle walk test (ESWT), compared to TIO alone. Male and female subjects at least 40 years of age with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) are eligible. Subjects will be screened and consented at or during a 6-week (wk) period prior to visit (V)1. The 4-wk run-in period begins immediately after V1, when subjects receive open-label TIO plus as-needed relief inhaler (identical formulations called albuterol in the US and salbutamol in Canada). At V2, subjects will perform an incremental shuttle walk test (ISWT) to establish their maximal walk response. The first ESWT will occur at V3. Subjects must demonstrate an EET of ≤20 min that is reproducible (EET from V3 and V4 varying by ≤2 min). Eligible subjects are then randomized at V5 to either FSC 250/50mcg DISKUS twice daily plus open label TIO 18 mcg daily, or placebo DISKUS twice daily plus open label TIO 18 mcg daily for the 4-wk treatment period. The last study visit is V6. The primary efficacy measure is the difference between the EET at V6 (wk-8) vs. V4 (wk-3; the last ESWT done before randomized study drug is given). Secondary efficacy measures include V6 vs. V4 comparisons in exercise dyspnea scale (EDS), exercise inspiratory capacity (EIC) and cardio-respiratory measurements (CRM), and V6 vs. V5 comparisons in dyspnea related to activities of daily living (baseline dyspnea index and transition dyspnea index interviewer-administered [BDI-TDI]) and quality of life (Chronic Respiratory Disease Questionnaire Self-administered Standardized [CRQ-SAS]). The safety measure will be an assessment of adverse events. We will also attempt to validate prospectively the minimal clinically-important difference (MCID) for a change in the EET through correlation with dyspnea and quality of life results.

Read the detailed description

We postulate that adding fluticasone propionate/salmeterol combination DISKUS 250/50 (FSC) to tiotropium (TIO) will improve exercise endurance time (EET) and its clinical and physiologic correlates, based on the combination of the three different mechanisms of action represented. We propose to test this hypothesis by comparing outcomes of exercise testing (Endurance Shuttle Walk Test; ESWT) with FSC added to TIO compared to those on TIO alone.

The primary objective is to demonstrate that, when added to TIO, FSC significantly increases EET compared to TIO alone at Visit 6 (V6; week [wk]-8) vs. V4 (wk-3; the last ESWT before double-blind drug).

Secondary efficacy measures will be as follows. Exercise dyspnea scale (EDS), exercise inspiratory capacity (EIC) and cardio-respiratory measurements (CRM) will involve V6 vs. V4 comparisons. Dyspnea related to activities of daily living (ADLs) will be assessed using the baseline dyspnea index and transition dyspnea index interviewer-administered (BDI-TDI), and quality of life will be assessed using the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS). The BDI-TDI and CRQ-SAS will be based on comparisons of data from V6 vs. V5. We will also attempt to validate prospectively the minimal clinically-important difference (MCID) for a change in the EET through correlation with dyspnea (Likert scale).

Safety evaluations will include the type, incidence and severity of adverse events.

This is a randomized, parallel-group study totalling 6 visits. Screening is at or up to 6 wk prior to V1, and includes a discussion of study procedures, a review of inclusion/exclusion criteria, collection of informed written consent, adjustment of medications and determination of spirometry pre- and post-albuterol/salbutamol. At V1, subjects meeting inclusion criteria will be enrolled, familiarized with the incremental shuttle walk test (ISWT), and given paper diaries.

The run-in will begin with the dispensing of open-label medications at the end of V1. During the 4-wk run-in, subjects will have 3 visits (V2-V4). Open-label TIO will be taken daily beginning after V1, and open-label relief inhaler (identical formulations called albuterol in the US and salbutamol in Canada) will be taken on an as-needed basis beginning after V1. Open-label medications will be withheld before V2, V3 and V4 (last dose of TIO, the morning of the day before the visit; last dose of albuterol/salbutamol, at least 6 hr before the start of the visit). At V2, subjects will be given open-label TIO, will undergo ISWT 2.5-hr post-TIO, and will be familiarized with the ESWT. At V3 and V4, subjects will be given open-label TIO, and will undergo ESWT 2.5-hr post-TIO. ESWT will be performed again at V4 only if the EET at V3 was ≤20 min. Subjects will be studied at V5 if the EET result from V4 is also ≤20 min and the EET from V3 and V4 vary from each other by ≤2 min; otherwise, subjects will be withdrawn. The ESWT from V4 will be used as the baseline EET for exercise-related outcomes because it will be the last ESWT done before double-blind study drug is given.

Open-label medications will be withheld before V5 and V6 (last dose of TIO the morning of the day before the visit; last dose of albuterol/salbutamol, at least 6 hr before the start of the visit). At V5, subjects will undergo spirometry, lung volumes and diffusing capacity, and will be randomized. Subjects will then be given open-label TIO and double-blind DISKUS study drug, and undergo spirometry and lung volumes 2 hr post-TIO/double-blind DISKUS study drug, and ESWT 2.5 hr post-dose. Per randomization, subjects will receive for 4 wk after V5, open-label TIO plus either FSC or placebo DISKUS. Double-blind DISKUS study drug will be withheld before V6 (last dose the evening of the day before the visit). V6 will be the last study visit, consisting of spirometry and lung volumes, followed by open-label TIO and double-blind DISKUS study drug, spirometry and lung volumes 2 hr post-dose, and the final ESWT 2.5 hr post-dose.

All study visits will begin with a check-up to determine eligibility for further study procedures. Details of the paper diary report will be reviewed after drug administration, V2 through V6. Immediately after review of the paper diary, BDI (at V5), TDI (at V6) and CRQ-SAS (V5 and V6) will be undertaken, and the post-dose study activities, as outlined above, will follow.

Final contact will be by telephone approximately 2 wk after V6 or Early Withdrawal. The total duration of the study will be 8 wk, including the 4 wk run-in and the 4 wk period of double-blind plus open-label treatment. There will also be a screening period of up to 6 wk prior to V1, and the 2-wk period after the final study visit for phone call follow-up.

Subjects at a subset of sites will undergo EIC and CRM during each ESWT using portable telemetric monitoring (Oxycon Mobile; CareFusion, San Diego, CA).

Being tested
fluticasone propionate/salmeterol inhalation powder DISKUS 250/50, tiotropium bromide inhalation powder HandiHaler
Keywords
endurance shuttle walk test, chronic obstructive pulmonary disease, fluticasone propionate, dyspnea, exercise endurance time, tiotropium, salmeterol, exercise inspiratory capacity, quality of life
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Dyspnea

What participants receive

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

  • fluticasone propionate/salmeterol inhalation powder DISKUS 250/50Drug

    Experimental comparator consisting of inhaled corticosteroid plus long-acting beta agonist combination also known as ADVAIR DISKUS

  • tiotropium bromide inhalation powder HandiHalerDrug

    Open-label drug also known as Spiriva HandiHaler

Study groups in NCT01124422
Study groupRoleWhat they receive
fluticasone propionate/salmeterol DISKUS 250/50 + tiotropiumExperimentalThis is the active DISKUS (that is, containing fluticasone propionate/salmeterol combination) + open-label tiotropium
Receives: Drug: fluticasone propionate/salmeterol inhalation powder DISKUS 250/50; Drug: tiotropium bromide inhalation powder HandiHaler
placebo DISKUS + tiotropiumPlacebo comparatorThis is the DISKUS and excipient minus the active ingredient (which is fluticasone propionate/salmeterol combination) + open-label tiotropium
Receives: Drug: tiotropium bromide inhalation powder HandiHaler

What is being measured

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

  1. Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8

    EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

Secondary outcomes (18)

  1. Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8

    EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.

    Measured: Baseline (Week 3) and Week 8

  2. Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8

    EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  3. Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8

    Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.

    Measured: Baseline (Week 4) and Week 8

  4. Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8

    EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.

    Measured: Baseline (Week 3) and Week 8

  5. Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8

    The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin

    Measured: Baseline (Week 3) and Week 8

  6. Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8

    The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  7. Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8

    The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.

    Measured: Baseline (Week 3) and Week 8

  8. Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8

    HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.

    Measured: Baseline (Week 3) and Week 8

  9. Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8

    The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  10. Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8

    RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.

    Measured: Baseline (Week 3) and Week 8

  11. Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8

    RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  12. Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8

    VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.

    Measured: Baseline (Week 3) and Week 8

  13. Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8

    VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  14. Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)

    HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  15. Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8

    The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  16. Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8

    The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.

    Measured: Baseline (Week 3) and Week 8

  17. Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8

    The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).

    Measured: Week 4 and Week 8

  18. Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8

    The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.

    Measured: BDI: Week 4; TDI: Week 8

Timeline

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

  1. First posted17 May 2010 (estimated)
  2. Study start19 Jul 2010
  3. Primary completion1 May 2011
  4. Study completion2 May 2011

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
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124422
Sponsor's protocol ID
113877
Acronym
ESWT
Status last verified
Oct 2017
First submitted
13 May 2010
Last updated
8 Nov 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

  • Maltais F, Mahler DA, Pepin V, Nadreau E, Crater GD, Morris AN, Emmett AH, Ferro TJ. Effect of fluticasone propionate/salmeterol plus tiotropium versus tiotropium on walking endurance in COPD. Eur Respir J. 2013 Aug;42(2):539-41. doi: 10.1183/09031936.00074113. No abstract available.

    PubMed 23904549

  • Borel B, Pepin V, Mahler DA, Nadreau E, Maltais F. Prospective validation of the endurance shuttle walking test in the context of bronchodilation in COPD. Eur Respir J. 2014 Nov;44(5):1166-76. doi: 10.1183/09031936.00024314. Epub 2014 Sep 3.

    PubMed 25186261

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fluticasone propionate/salmeterol inhalation powder DISKUS 250/50 and tiotropium bromide inhalation powder HandiHaler in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 27 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 21 inclusion and 23 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. 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 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 21 Dec 2011). 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 in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8 (time frame: Baseline (Week 3) and Week 8). 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 NCT01124422, which also lists 2 linked publications.

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 8 Nov 2017.

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