Pulmonary Disease, Chronic ObstructivePhase 2NCT01218126

Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD).

A Phase 2 study testing losmapimod in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 48 sites in 8 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

Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. 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?: losmapimod
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 604 participants
Where: 48 sitesin 8 countries
Study dates: 4 Nov 2010to 21 Dec 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age
current or prior history of ≥10 pack-years of cigarette smoking

Show all 9Show fewer

aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN)
alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG.

Who cannot join

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
exacerbation of COPD within previous 12 weeks

Show all 15Show fewer

treatment with roflumilast within previous 2 weeks and throughout the treatment period
lower respiratory tract infection that required the use of antibiotics within previous 12 weeks
long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day
participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study
carcinoma that has not been in complete remission for at least 5 years
current or chronic history of liver disease
positive Hepatitis B surface antigen or positive Hepatitis C antibody
Body Mass Index (BMI) > 35
known or suspected history of alcohol or drug abuse within the last 2 years

Trial locations and contacts

48 sites in 8 countries.

Country

City, postcode or hospital

48 sites in 8 countries

Germany10 sites

GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 13581
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Gelnhausen, Hesse, 63571
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, 20354
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428

Other trials in Germany

United States8 sites

GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Torrance, California, 90505

Other trials in United States

Argentina7 sites

GSK Investigational Site
Buenos Aires, C1120AAC
GSK Investigational Site
Buenos Aires, C1426ABP
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600
GSK Investigational Site
Mendoza, 5500
GSK Investigational Site
Mendoza, M5500CCG
GSK Investigational Site
Rosario, Santa Fe Province, S2000DSR
GSK Investigational Site
San Miguel de Tucumán, 4000

Other trials in Argentina

Norway6 sites

GSK Investigational Site
Bergen, N-5021
GSK Investigational Site
Follebu, 2656
GSK Investigational Site
Harstad, 9480
GSK Investigational Site
Levanger, 7600
GSK Investigational Site
Stavanger, 4011
GSK Investigational Site
Trondheim, 7030

Other trials in Norway

South Korea5 sites

GSK Investigational Site
Seoul, 100-032
GSK Investigational Site
Seoul, 130-702
GSK Investigational Site
Seoul, 130-848
GSK Investigational Site
Seoul, 134-701
GSK Investigational Site
Seoul

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Ukraine5 sites

GSK Investigational Site
Donetsk, 83003
GSK Investigational Site
Donetsk, 83099
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kyiv, 03115
GSK Investigational Site
Kyiv, 03680

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Czechia4 sites

GSK Investigational Site
Ostrava - Poruba, 70868
GSK Investigational Site
Prague, 182 00
GSK Investigational Site
Tábor, 390 19
GSK Investigational Site
Zlín, 762 75

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Estonia3 sites

GSK Investigational Site
Tallinn, 10138
GSK Investigational Site
Tallinn, 13619
GSK Investigational Site
Tartu, 51014

Other trials in Estonia

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: losmapimod, placebo
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.

losmapimodDrug
comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg
placeboDrug
placebo comparison with active

Study groups in NCT01218126
Study group	Role	What they receive
losmapimod 2.5 mg	Experimental	losmapimod 2.5 mg Receives: Drug: losmapimod
placebo	Placebo comparator	Not described Receives: Drug: placebo
losmapimod 7.5 mg	Experimental	losmapimod 7.5 mg Receives: Drug: losmapimod
losmapimod 15 mg	Experimental	losmapimod 15 mg Receives: Drug: losmapimod

What is being measured

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

Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24
Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = [100 x (6MWD2 - 6MWD1)]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Measured: Baseline (Week 0) and Week 4, 12, 24

Secondary outcomes (7)

Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Pre and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.Baseline visit was Visit 2 (Week 0).
Measured: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
FVC is the total amount of air exhaled during the lung function test. and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.. Baseline visit was Visit 2 (Week 0).
Measured: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24
Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24
The SGRQ-C questionnaire had 14 questions of COPD and participant had to rate each question. These 14 questions were separated to evaluate the three components of SGRQ-C. These three components were symptom component (question 1 to 7), activity component (question 9 and 12) and impact component (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Change from Baseline was calculated as the specified time point value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Measured: Baseline (Week 0) and Week 12, 24
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). Plethysmography was used to assess IC, RV, TGV at FRC, SLV, and TLC. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).
Measured: Baseline(Week 0) and Week 12, 24
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Least square mean ratio to Baseline of plasma fibrinogen was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.
Measured: Baseline (Week 0) and Week 4, 8, 12, 24
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Least square mean ratio to Baseline of HsCRP was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.
Measured: Baseline (Week 0) and Week 4, 8, 12, 24
Total Number of Exacerbations Over 24 Weeks
An exacerbation of COPD is defined as a worsening of COPD symptoms requiring changes to normal treatment (other than increased use of relief salbutamol/albuterol) including antimicrobial therapy, short courses of oral steroids, other bronchodilator therapy and/or emergency treatment or hospitalization.
Measured: Up to 24 weeks

Timeline

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

4 Nov 201021 Dec 2011

First posted11 Oct 2010 (estimated)
Study start4 Nov 2010
Primary completion21 Dec 2011
Study completion21 Dec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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, Investigator, Outcomes assessor
Enrolment: 604 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01218126
Sponsor's protocol ID: 113006
Status last verified: Jan 2018
First submitted: 7 Oct 2010
Last updated: 6 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
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

Largajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.
PubMed 31197640
Watz H, Barnacle H, Hartley BF, Chan R. Efficacy and safety of the p38 MAPK inhibitor losmapimod for patients with chronic obstructive pulmonary disease: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):63-72. doi: 10.1016/S2213-2600(13)70200-5. Epub 2013 Dec 5.
PubMed 24461903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01218126
Acronym / sponsor ID: 113006
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 604 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Nov 2010 (actual)
Primary completion: 21 Dec 2011 (actual)
Study completion: 21 Dec 2011 (actual)
First posted: 11 Oct 2010 (estimated)
Results: Posted 4 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
losmapimod 2.5 mg	Experimental	Drug: losmapimodlosmapimod 2.5 mg
placebo	Placebo comparator	Drug: placebo
losmapimod 7.5 mg	Experimental	Drug: losmapimodlosmapimod 7.5 mg
losmapimod 15 mg	Experimental	Drug: losmapimodlosmapimod 15 mg

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
FEV1/FVC ratio of ≤0.70
FEV1 ≤ 80% of predicted normal
6MWD < 350m
male or female outpatients aged ≥40 years of age

Key exclusion criteria (15 listed)

current diagnosis of asthma
pregnant or lactating
α1-antitrypsin deficiency
lung resection
chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
losmapimodcomparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg	Drug	losmapimod 15 mg, losmapimod 2.5 mg, losmapimod 7.5 mg
placeboplacebo comparison with active	Drug	placebo

Primary outcome

Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24
Time frame: Baseline (Week 0) and Week 4, 12, 24
Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = [100 x (6MWD2 - 6MWD1)]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).

7 secondary outcomes

Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24
Time frame: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24
Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24
Time frame: Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24
Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24
Time frame: Baseline (Week 0) and Week 12, 24
Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24
Time frame: Baseline(Week 0) and Week 12, 24
Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks
Time frame: Baseline (Week 0) and Week 4, 8, 12, 24
Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks
Time frame: Baseline (Week 0) and Week 4, 8, 12, 24
Total Number of Exacerbations Over 24 Weeks
Time frame: Up to 24 weeks

Results and safety

Results posted to the registry on 4 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	153	129
Losmapimod 2.5 mg	149	127
Losmapimod 7.5 mg	151	127
Losmapimod 15 mg	149	114

Primary outcome: Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24

Time frame: Baseline (Week 0) and Week 4, 12, 24. Least squares mean (Standard Error). Unit: Meter (m)

Measure	Placebo n = 153	Losmapimod 2.5 mg n = 149	Losmapimod 7.5 mg n = 151	Losmapimod 15 mg n = 149
Week 4	314.4 (2.79)	311.8 (2.84)	313.2 (2.78)	319.9 (2.83)
Week 12	321.6 (3.53)	322.2 (3.58)	320.2 (3.50)	323.4 (3.65)
Week 24	330.6 (4.13)	324.0 (4.19)	325.9 (4.09)	327.2 (4.27)

Placebo vs Losmapimod 2.5 mg: Mean Difference (Net): -2.6 (95% CI -10.4 to 5.2), p = 0.517, mixed model repeated measures
Placebo vs Losmapimod 7.5 mg: Mean Difference (Net): -1.2 (95% CI -8.9 to 6.5), p = 0.763, mixed model repeated measures
Placebo vs Losmapimod 15 mg: Mean Difference (Net): 5.5 (95% CI -2.3 to 13.3), p = 0.164, mixed model repeated measures

Population analysed: Intent-to-treat (ITT) population consisted of all participants randomized to treatment and who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data for adverse event (AE) was collected up to 1 week after the end of treatment (Week 24) or an early withdrawal visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	17 of 153 (11.1%)	51 of 153 (33.3%)	3 of 153
Losmapimod 2.5 mg	12 of 149 (8.1%)	49 of 149 (32.9%)	0 of 149
Losmapimod 7.5 mg	14 of 151 (9.3%)	51 of 151 (33.8%)	1 of 151
Losmapimod 15 mg	15 of 149 (10.1%)	48 of 149 (32.2%)	2 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31197640Largajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.
Derived from this study: PubMed 24461903Watz H, Barnacle H, Hartley BF, Chan R. Efficacy and safety of the p38 MAPK inhibitor losmapimod for patients with chronic obstructive pulmonary disease: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):63-72. doi: 10.1016/S2213-2600(13)70200-5. Epub 2013 Dec 5.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Pulmonary Disease, Chronic Obstructive

Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

48 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing losmapimod in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 48 sites in 8 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 9 inclusion and 15 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 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany, United States, Argentina, Norway, South Korea and 3 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 4 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24 (time frame: Baseline (Week 0) and Week 4, 12, 24). 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 NCT01218126, 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 6 Feb 2018.