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Pulmonary Disease, Chronic ObstructivePhase 2NCT00606684

A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing GW642444 6.25, GW642444 3mcg and GW642444 12.5mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 99 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

This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (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?
GW642444 6.25, GW642444 3mcg and GW642444 12.5mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
602 participants
Where
99 sitesin 14 countries
Study dates
Feb 2008to Oct 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

  • Subjects eligible for enrollment in the study must meet all of the following criteria:
  • Informed Consent: Subjects who give their signed written informed consent to participate.
  • Gender: Male or females who are 40 - 80 years of age at Visit 1. A female is 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
  • Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
  • Complete abstinence from intercourse from screening until 2 weeks after the follow-up contact; or
Show all 19Show fewer
  • Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
  • Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
  • Injectable progestogen administered for at least 1 month prior to study medication administration and administered for 1 month following study completion; or
  • Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
  • Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
  • An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
  • Estrogenic vaginal ring; or
  • Percutaneous contraceptive patches
  • COPD Diagnosis: Subjects with an established clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
  • Tobacco Use: Must have current or prior history of at least 10 pack-years of cigarette smoking. [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
  • Severity of Disease:
  • Subjects with a measured post-salbutamol FEV1/FVC ratio of ≤0.70 at Visit 1 (Screening).
  • Subjects with a measured post-salbutamol FEV1 ≥35 and ≤70% of predicted normal values calculated using NHANES III reference equations at Visit 1 (Screening).

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Pregnancy: Women who are pregnant or lactating.
  • Asthma: Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis)
  • a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD.
  • Other Respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary disease.
  • Lung Resection: Subjects with lung volume reduction surgery within the previous 12 months.
Show all 54Show fewer
  • Chest X-ray: Chest X-ray (or CT scan) reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest x-ray must be taken if a chest x-ray or CT scan is not available within the 6 months preceding the Screening Visit. For sites in Germany, if a chest x-ray (or CT scan) is not available in the 6 months preceding the Screening (Visit 1), the subject will not be eligible for the study.
  • Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of the screening visit.
  • Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Visit 1:
  • acute worsening of COPD that is managed by subject with corticosteroids or antibiotics, or
  • acute worsening of COPD that requires treatment prescribed by a physician
  • Other Diseases/Abnormalities: Subjects with clinically significant cardiovascular neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
  • Lower Respiratory Tract Infection: Subjects with lower respiratory tract infections which required the use of antibiotics within 6 weeks prior to visit 1.
  • 12-Lead ECG: An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in an active medical problem. For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
  • Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
  • Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia)
  • The investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. However, the following predetermined ECG abnormalities are considered clinically significant and will result in exclusion of a subject:
  • A mean QTc(B) value at screening >450msec, or uncorrected QT>600msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
  • Ventricular rate < 45 beats per minute.
  • PR interval > 240msec.
  • Evidence of second or third degree atrioventricular (AV) block
  • Pathological Q waves
  • Non-specific intraventricular conduction delay
  • ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities)
  • Right or left complete bundle branch block
  • Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
  • Hepatitis: Subjects with a positive Hepatitis B surface antigen or positive hepatitis C antibody pre-study or at Screening.
  • Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma would not be excluded if the subject was considered cured in less than 5 years since diagnosis.
  • Drug allergy: Subjects with a history of hypersensitivity to any beta-agonist or any component of the MDI and/or nebule or sensitivity to any of the constituents of the dry powder product (magnesium stearate or lactose). In addition patients with a history of severe milk protein allergy would also be excluded.
  • Drug abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
  • Medication prior to spirometry: Subjects who are medically unable to withhold their salbutamol for the 6 hour period required prior to spirometry testing at each study visit would be ineligible for the study.
  • Additional Medications: The following medications are not permitted during this study and must not have been taken for the indicated times prior to Visit 1 (See Prohibited Medications): Medication (Required period of time prior to screening visit):
  • Ipratropium or ipratropium/salbutamol combination product (6 hours)
  • Inhaled short acting beta-agonists (study salbutamol will be provided)(6 hours)
  • Oral beta2-agonists (48 hours)
  • LABAs (salmeterol and formoterol)(48 hours)
  • Corticosteroids/Long acting beta-agonist combination products (48 hours for the LABA component)
  • Theophylline preparations (48 hours)
  • Cromolyn and nedocromil inhalers(24 hours)
  • Zafirlukast, montelukast, zileuton(48 hours)
  • Tiotropium (1 Week)
  • Depot corticosteroids (12 Weeks)
  • Intra-articular corticosteroids (24 hours)
  • Inhaled corticosteroids>1000mcg/day of fluticasone propionate or equivalent (4 Weeks)
  • Any other investigational medication (30 days or within 5 drug half-lives of the investigational drug (whichever is longer))
  • P-glycoprotein inhibitors (e.g., ritonavir, ketoconazole) or Cytochrome P 3A4 inhibitors (e.g., cimetidine) (4 weeks (grapefruit is allowed up to the screening visit))
  • Other Medications: Subjects receiving treatment with tricyclic antidepressants, MAOs, beta-adrenergic antagonists, anticonvulsants (barbiturates, hydantoins, and carbamazepine) or phenothiazines would be ineligible for the study.
  • Oxygen: Subjects receiving long-term-oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use is not exclusionary.
  • Sleep apnea: Subjects with clinically significant sleep apnea that is uncontrolled.
  • Pulmonary Rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Visit 1 (Screening) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation program are not excluded.
  • Non-compliance: Subjects unable to comply with study procedures.
  • Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participation in this study.
  • Questionable validity of Consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse, (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
  • Prior use of Study Medication: Subjects who have received the investigational drug GW642444 in previous studies.

Trial locations and contacts

99 sites in 14 countries.

99 sites in 14 countries

United States49 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Butte, Montana, 59701

  • GSK Investigational Site

    Carmel, Indiana, 46032

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Dallas, Texas, 75216

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Detroit, Michigan, 48201-2018

  • GSK Investigational Site

    Elkhart, Indiana, 46515

  • GSK Investigational Site

    Elmira, New York, 14901

  • GSK Investigational Site

    Florence, Alabama, 35630

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • 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

    Lakewood, California, 90712

  • GSK Investigational Site

    Larchmont, New York, 10538

  • GSK Investigational Site

    Livonia, Michigan, 48152

  • GSK Investigational Site

    Los Angeles, California, 90095-1752

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Montgomery, Alabama, 36109

  • GSK Investigational Site

    New Albany, Indiana, 47150

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Portland, Oregon, 97220

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Sepuldeva, California, 91343

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63122

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Summit, New Jersey, 07091

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Union, South Carolina, 29379

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Waco, Texas, 76712

Other trials in United States

Germany8 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 14057

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Landsberg am Lech, Bavaria, 86899

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Munich, Bavaria, 80539

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

Other trials in Germany

Canada6 sites

  • GSK Investigational Site

    Bathurst, New Brunswick, E2A 4X7

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Montreal, Quebec, H3H 2R9

  • GSK Investigational Site

    Saskatoon, Ontario, S7N 0W8

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

Other trials in Canada

Russia6 sites

  • GSK Investigational Site

    Moscow, 105077

  • GSK Investigational Site

    Moscow, 125315

  • GSK Investigational Site

    Samara, 443079

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Smolensk, 214001

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Poland5 sites

  • GSK Investigational Site

    Gidle, 97-540

  • GSK Investigational Site

    Prabuty, 82-550

  • GSK Investigational Site

    Warsaw, 01-138

  • GSK Investigational Site

    Warsaw, 02-097

  • GSK Investigational Site

    Zabrze, 41-803

Other trials in Poland

Mexico4 sites

  • GSK Investigational Site

    México, 11550

  • GSK Investigational Site

    Mexico City, 06720

  • GSK Investigational Site

    Monterrey NL, Nuevo León, 64718

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

Argentina3 sites

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Mendoza, Mendoza Province, M5500CCG

  • GSK Investigational Site

    Vicente López, Buenos Aires, B1602DOH

Other trials in Argentina

Denmark3 sites

  • GSK Investigational Site

    Hellerup, 2900

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

Estonia3 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Philippines3 sites

  • GSK Investigational Site

    Lipa City, 4217

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

Slovakia3 sites

  • GSK Investigational Site

    Bratislava, 821 06

  • GSK Investigational Site

    Šaľa, 927 01

  • GSK Investigational Site

    Spišská Nová Ves, 052 01

Other trials in Slovakia

Chile2 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Peru2 sites

  • GSK Investigational Site

    Lima, Lima Province, Lima 1

  • GSK Investigational Site

    San Isidro, Lima region, Lima 27

Other trials in Peru

South Korea2 sites

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 152-703

Other trials in South Korea

About this study

Official title: Study B2C111045, A Dose-Finding Study of GW642444 Versus Placebo in Patients With COPD

This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)

Being tested
GW642444 6.25, GW642444 3mcg, GW642444 12.5mcg, GW642444 25mcg, GW642444 50mcg
Keywords
Chronic Obstructive Pulmonary Disease (COPD), COPD, GW642444
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.

  • GW642444 6.25Drug

    GW642444 6.25

  • GW642444 3mcgDrug

    Also called GW642444

    once daily

  • GW642444 12.5mcgDrug

    GW642444 12.5mcg

  • GW642444 25mcgDrug

    GW642444 25mcg

  • GW642444 50mcgDrug

    GW642444 50mcg

  • placeboOther

    placebo

Study groups in NCT00606684
Study groupRoleWhat they receive
GW642444Active comparatorGW642444
Receives: Drug: GW642444 6.25; Drug: GW642444 3mcg; Drug: GW642444 12.5mcg; Drug: GW642444 25mcg; Drug: GW642444 50mcg
placeboPlacebo comparatorNot described
Receives: Other: placebo

What is being measured

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

  1. Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29

    Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).

    Measured: Baseline (BL) and Day 29

Secondary outcomes (3)

  1. Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28

    Weighted mean was derived by calculating the AUC, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24 hour serial FEV1 measures on Day 1 and Day 28 minus the Baseline value. Serial FEV1 measurements were taken on Day 1 and Day 28 (post-dose FEV1 after 5, 15, 30 minutes and 1, 2, 4, 8, 12, 23 and 24 hours). AUC was calculated only when there was at least 3 non-missing values between 0 and 24 hours and must have a value at 23 or 24 hours. Analysis performed used a repeated measures model with covariates of treatment, baseline, sex, age, smoking status (at Screening), reversibility stratum, Day (nominal), day by Baseline, and day by treatment interactions.

    Measured: Baseline to Day 28

  2. Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)

    Forced expiratory volume in one second (FEV1) is a measure of lung function defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieved a >=12% increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 on Day 1.Time to >= 12% increase from Baseline (on Day 1) is defined as the time when the first post-dose FEV1 (on Day 1) is >=12% above Baseline FEV1. Time to >= 12% increase from Baseline was assessed over the 0-4 hour time period and only used lung function data recorded up to 6 hours post the Day 1 dose.

    Measured: Baseline and Day 1

  3. Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)

    Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Time until participants achieve >=100 mL increase from Baseline FEV1 (0-4 hours post-dose) are presented. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to >= 100mL increase from Baseline (on Day 1) is defined as the time until the first post-dose FEV1 (on Day 1) is >= 100mL above Baseline FEV1. Time to >= 100mL increase from Baseline (on Day 1) was calculated only if there was at least one non-missing FEV1 value recorded within the first hour of dosing. Time to >= 100mL increase from Baseline was assessed over the 0-4 time period and only used lung function data recorded up to 6 hours post the Day 1 dose. Participants who did not achieve >= 100mL increase from Baseline over this time period were censored.

    Measured: Baseline and Day 1

Timeline

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

  1. First posted4 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionOct 2008
  4. Study completionOct 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00606684
Sponsor's protocol ID
B2C111045
Status last verified
Nov 2016
First submitted
18 Jan 2008
Last updated
16 Dec 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, Feldman G, Zachgo W, Shim JJ, Crim C, Sanford L, Lettis S, Barnhart F, Haumann B. The efficacy and safety of the novel long-acting beta2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest. 2012 Jul;142(1):119-127. doi: 10.1378/chest.11-2231.

    PubMed 22241764

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW642444 6.25, GW642444 3mcg and GW642444 12.5mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 99 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 19 inclusion and 54 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Germany, Canada, Russia, Poland 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 17 Sep 2013). 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 Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29 (time frame: Baseline (BL) 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 NCT00606684, 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 16 Dec 2016.

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