AsthmaPhase 2NCT01092143

BI 671800 ED in Steroid-naive Asthmatic Patients

A Phase 2 study testing BI 671800 and Fluticasone propionate in people with Asthma, run by Boehringer Ingelheim at 92 sites in 10 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 is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: BI 671800 and Fluticasone propionate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 389 participants
Where: 92 sitesin 10 countries
Study dates: 18 Mar 2010to 26 Mar 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent consistent with ICH-GCP
Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
No ICS previous 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
ACQ at least 1.5 at randomization.
Male or female, 18 to 65 years.
Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
Able to perform PFT

Who cannot join

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 ULN.
Hospitalizations for asthma or asthma related intubation within 3 months.
Uncontrolled asthma.
Respiratory tract infection or exacerbation within 4 weeks.
FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.

Show all 9Show fewer

Participation in another interventional study.
Pregnant or nursing women.
Women of child bearing potential nor using appropriate methods of birth control as defined by protocol

Trial locations and contacts

92 sites in 10 countries.

Country

City, postcode or hospital

92 sites in 10 countries

United States40 sites

1268.17.01034 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1268.17.01008 Boehringer Ingelheim Investigational Site
Bellevue, Nebraska
1268.17.01022 Boehringer Ingelheim Investigational Site
Bozeman, Montana
1268.17.01007 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1268.17.01004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1268.17.01015 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1268.17.01009 Boehringer Ingelheim Investigational Site
Cypress, California
1268.17.01019 Boehringer Ingelheim Investigational Site
Dallas, Texas
1268.17.01045 Boehringer Ingelheim Investigational Site
DeLand, Florida
1268.17.01001 Boehringer Ingelheim Investigational Site
Denver, Colorado
1268.17.01031 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1268.17.01012 Boehringer Ingelheim Investigational Site
El Paso, Texas
1268.17.01039 Boehringer Ingelheim Investigational Site
Fort Mill, South Carolina
1268.17.01026 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1268.17.01029 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1268.17.01023 Boehringer Ingelheim Investigational Site
Houston, Texas
1268.17.01005 Boehringer Ingelheim Investigational Site
Iowa City, Iowa
1268.17.01048 Boehringer Ingelheim Investigational Site
Killeen, Texas
1268.17.01016 Boehringer Ingelheim Investigational Site
Lakewood, Colorado
1268.17.01006 Boehringer Ingelheim Investigational Site
Los Angeles, California
1268.17.01032 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1268.17.01028 Boehringer Ingelheim Investigational Site
New Braunfels, Texas
1268.17.01036 Boehringer Ingelheim Investigational Site
Normal, Illinois
1268.17.01014 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1268.17.01030 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1268.17.01027 Boehringer Ingelheim Investigational Site
Novi, Michigan
1268.17.01038 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1268.17.01040 Boehringer Ingelheim Investigational Site
Palmdale, California
1268.17.01042 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1268.17.01011 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1268.17.01035 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1268.17.01024 Boehringer Ingelheim Investigational Site
San Jose, California
1268.17.01025 Boehringer Ingelheim Investigational Site
South Bend, Indiana
1268.17.01049 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1268.17.01010 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1268.17.01037 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1268.17.01003 Boehringer Ingelheim Investigational Site
Stockton, California
1268.17.01047 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1268.17.01043 Boehringer Ingelheim Investigational Site
Tucson, Arizona
1268.17.01033 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado

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Taiwan12 sites

1268.17.86210 Boehringer Ingelheim Investigational Site
Chiayi City
1268.17.86211 Boehringer Ingelheim Investigational Site
Kaohsiung City
1268.17.86207 Boehringer Ingelheim Investigational Site
Taichung
1268.17.86208 Boehringer Ingelheim Investigational Site
Taichung
1268.17.86209 Boehringer Ingelheim Investigational Site
Taichung
1268.17.86201 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86202 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86203 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86204 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86205 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86206 Boehringer Ingelheim Investigational Site
Taipei
1268.17.86200 Boehringer Ingelheim Investigational Site
Taoyuan County

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Canada8 sites

1268.17.02015 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1268.17.02012 Boehringer Ingelheim Investigational Site
Hawkesbury, Ontario
1268.17.02010 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
1268.17.02014 Boehringer Ingelheim Investigational Site
Newmarket, Ontario
1268.17.02001 Boehringer Ingelheim Investigational Site
Québec, Quebec
1268.17.02004 Boehringer Ingelheim Investigational Site
Québec, Quebec
1268.17.02003 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1268.17.02013 Boehringer Ingelheim Investigational Site
Toronto, Ontario

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South Korea8 sites

1268.17.82007 Boehringer Ingelheim Investigational Site
Cheongju-si
1268.17.82001 Boehringer Ingelheim Investigational Site
Seoul
1268.17.82002 Boehringer Ingelheim Investigational Site
Seoul
1268.17.82004 Boehringer Ingelheim Investigational Site
Seoul
1268.17.82005 Boehringer Ingelheim Investigational Site
Seoul
1268.17.82006 Boehringer Ingelheim Investigational Site
Seoul
1268.17.82003 Boehringer Ingelheim Investigational Site
Suwon
1268.17.82008 Boehringer Ingelheim Investigational Site
Wŏnju

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Philippines7 sites

1268.17.63007 Boehringer Ingelheim Investigational Site
Caloocan
1268.17.63002 Boehringer Ingelheim Investigational Site
Manila
1268.17.63001 Boehringer Ingelheim Investigational Site
Quezon City
1268.17.63003 Boehringer Ingelheim Investigational Site
Quezon City
1268.17.63004 Boehringer Ingelheim Investigational Site
Quezon City
1268.17.63005 Boehringer Ingelheim Investigational Site
Quezon City
1268.17.63006 Boehringer Ingelheim Investigational Site
Quezon City

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Peru6 sites

1268.17.51003 Boehringer Ingelheim Investigational Site
Jesús María
1268.17.51002 Boehringer Ingelheim Investigational Site
Lima
1268.17.51006 Boehringer Ingelheim Investigational Site
San Borja
1268.17.51004 Boehringer Ingelheim Investigational Site
San Isidro
1268.17.51005 Boehringer Ingelheim Investigational Site
Santiago de Surco
1268.17.51001 Boehringer Ingelheim Investigational Site
Urb. Ingeniería

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Mexico4 sites

1268.17.52002 Boehringer Ingelheim Investigational Site
Cuernavaca
1268.17.52001 Boehringer Ingelheim Investigational Site
Monterrey
1268.17.52004 Boehringer Ingelheim Investigational Site
Toriello Guerra
1268.17.52003 Boehringer Ingelheim Investigational Site
Zona Río

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Colombia3 sites

1268.17.57003 Boehringer Ingelheim Investigational Site
Bogotá
1268.17.57004 Boehringer Ingelheim Investigational Site
Bogotá
1268.17.57002 Boehringer Ingelheim Investigational Site
Medellín

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New Zealand3 sites

1268.17.64001 Boehringer Ingelheim Investigational Site
Christchurch
1268.17.64003 Boehringer Ingelheim Investigational Site
Greenlane East Auckland
1268.17.64002 Boehringer Ingelheim Investigational Site
Newtown Wellington NZ

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Australia1 site

1268.17.61001 Boehringer Ingelheim Investigational Site
Adelaide, South Australia

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About this study

Official title: A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

Conditions: Asthma
Being tested: BI 671800, Fluticasone propionate placebo, Fluticasone propionate, BI 671800 Placebo
Medical subject headings: Asthma

What participants receive

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

BI 671800Drug
BI 671800
Fluticasone propionate placeboDrug
Placebo matching Fluticasone propionate
Fluticasone propionateDrug
Fluticasone propionate
BI 671800 PlaceboDrug
Placebo matching BI 671800

Study groups in NCT01092143
Study group	Role	What they receive
BI 671800 (low dose)	Experimental	Patients receive BI 671800 (low dose) capsules twice daily Receives: Drug: BI 671800; Drug: Fluticasone propionate placebo
Fluticasone propionate	Active comparator	Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily Receives: Drug: Fluticasone propionate; Drug: BI 671800 Placebo
Placebo	Placebo comparator	Patients receive placebo capsules twice daily Receives: Drug: Fluticasone propionate placebo; Drug: BI 671800 Placebo
BI 671800 (medium dose)	Experimental	Patients receive BI 671800 (medium dose) capsules twice daily Receives: Drug: BI 671800; Drug: Fluticasone propionate placebo
BI 671800 (high dose)	Experimental	Patients receive BI 671800 (high dose) capsules twice daily Receives: Drug: BI 671800; Drug: Fluticasone propionate placebo

What is being measured

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

Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.
MMRM in the statistical test comments is mixed effects model with repeated measures.
Measured: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

Secondary outcomes (1)

Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment
Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.
The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Measured: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Timeline

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

18 Mar 201026 Mar 2011

First posted24 Mar 2010 (estimated)
Study start18 Mar 2010
Primary completion26 Mar 2011
Study completion26 Mar 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.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Double blind
Enrolment: 389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01092143
Sponsor's protocol ID: 1268.17
Status last verified: May 2022
First submitted: 19 Mar 2010
Last updated: 31 May 2022
Results posted: Yes, on ClinicalTrials.gov

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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma
ClinicalTrials.gov ID: NCT01092143
Acronym / sponsor ID: 1268.17
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 389 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Mar 2010 (actual)
Primary completion: 26 Mar 2011 (actual)
Study completion: 26 Mar 2011 (actual)
First posted: 24 Mar 2010 (estimated)
Results: Posted 31 May 2022

Clinical summary

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

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
BI 671800 (low dose)	Experimental	Drug: BI 671800, Drug: Fluticasone propionate placeboPatients receive BI 671800 (low dose) capsules twice daily
Fluticasone propionate	Active comparator	Drug: Fluticasone propionate, Drug: BI 671800 PlaceboPatients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily
Placebo	Placebo comparator	Drug: Fluticasone propionate placebo, Drug: BI 671800 PlaceboPatients receive placebo capsules twice daily
BI 671800 (medium dose)	Experimental	Drug: BI 671800, Drug: Fluticasone propionate placeboPatients receive BI 671800 (medium dose) capsules twice daily
BI 671800 (high dose)	Experimental	Drug: BI 671800, Drug: Fluticasone propionate placeboPatients receive BI 671800 (high dose) capsules twice daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed informed consent consistent with ICH-GCP
Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
No ICS previous 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
ACQ at least 1.5 at randomization.

Key exclusion criteria (9 listed)

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 ULN.
Hospitalizations for asthma or asthma related intubation within 3 months.
Uncontrolled asthma.
Respiratory tract infection or exacerbation within 4 weeks.

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
BI 671800BI 671800	Drug	BI 671800 (high dose), BI 671800 (low dose), BI 671800 (medium dose)
Fluticasone propionate placeboPlacebo matching Fluticasone propionate	Drug	BI 671800 (high dose), BI 671800 (low dose), BI 671800 (medium dose), Placebo
Fluticasone propionateFluticasone propionate	Drug	Fluticasone propionate
BI 671800 PlaceboPlacebo matching BI 671800	Drug	Fluticasone propionate, Placebo

Primary outcome

Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures.

1 secondary outcome

Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment
Time frame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Results and safety

Results posted to the registry on 31 May 2022, 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	78	63
BI 671800 50 mg Bid	77	70
BI 671800 200 mg Bid	84	80
BI 671800 400 mg Bid	79	72
Fluticasone 220 mcg Bid	71	63

Primary outcome: Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment

Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.. Mean (Standard Deviation). Unit: FEV1 percent predicted

Measure	Placebo n = 63	BI 671800 50 mg Bid n = 69	BI 671800 200 mg Bid n = 81	BI 671800 400 mg Bid n = 71	Fluticasone 220 mcg Bid n = 63
Value	-2.010 (1.187)	1.073 (1.144)	1.580 (1.074)	1.967 (1.133)	6.610 (1.194)

Placebo vs BI 671800 50 mg Bid: Adjusted mean treatment differences: 3.083 (95% CI -0.157 to 6.323), p = 0.0311, Mixed Models Analysis
Placebo vs BI 671800 200 mg Bid: Adjusted mean treatment differences: 3.589 (95% CI 0.447 to 6.732), p = 0.0126, Mixed Models Analysis
Placebo vs BI 671800 400 mg Bid: Adjusted mean treatment differences: 3.977 (95% CI 0.756 to 7.197), p = 0.0078, Mixed Models Analysis

Population analysed: Statistical analysis was performed on the Full Analysis Set (FAS): Randomized patients who received at least one dose of treatment and had both baseline and at least one post-baseline measurement at or before 6 weeks for the primary efficacy variable.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 78 (1.3%)	14 of 78 (17.9%)	0 of 78
BI 671800 50 mg Bid	0 of 77 (0%)	15 of 77 (19.5%)	0 of 77
BI 671800 200 mg Bid	0 of 83 (0%)	9 of 83 (10.8%)	0 of 83
BI 671800 400 mg Bid	1 of 79 (1.3%)	14 of 79 (17.7%)	0 of 79
Fluticasone 220 mcg Bid	0 of 71 (0%)	11 of 71 (15.5%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

92 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 671800 and Fluticasone propionate in people with Asthma, run by Boehringer Ingelheim at 92 sites in 10 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 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Taiwan, Canada, South Korea, Philippines and 5 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 31 May 2022). 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?

Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment (time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.). 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 NCT01092143.

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 31 May 2022.