Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01908140

Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Aclidinium Bromide / Formoterol Fumarate and Salmeterol / Fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 126 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

The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD) Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Aclidinium Bromide / Formoterol Fumarate and Salmeterol / Fluticasone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 933 participants
Where: 126 sitesin 14 countries
Study dates: Sep 2013to Aug 2014
Phase: Phase 3
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

Adult male or non-pregnant, non-lactating female aged ≥40.
Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits
Patients eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained

Who cannot join

History or current diagnosis of asthma
Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
Clinically significant respiratory conditions
Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit
Use of long-term oxygen therapy (≥15 hours/day)

Show all 20Show fewer

Patients treated on daily basis with triple therapy (LABA+LAMA+ICS) within 4 weeks prior to the Screening Visit
Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers
Clinically significant cardiovascular conditions
Patient with clinically relevant abnormalities in the results of the clinical laboratory tests, ECG parameters or in the physical examination at the Screening Visit
Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
Patient with any other serious or uncontrolled physical or mental dysfunction
Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
Patient unlikely to be cooperative or that can't comply with the study procedures
Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Screening Visit
Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study

Trial locations and contacts

126 sites in 14 countries.

Country

City, postcode or hospital

126 sites in 14 countries

Germany31 sites

Almirall Investigational Site
Berlin, 10117
Almirall Investigational Site
Berlin, 10629
Almirall Investigational Site
Berlin, 10717
Almirall Investigational Site
Berlin, 10969
Almirall Investigational Site
Berlin, 12043
Almirall Investigational Site
Berlin, 13125
Almirall Investigational Site
Berlin, 13581
Almirall Investigational Site
Berlin, 14059
Almirall Investigational Site
Bochum, 44789
Almirall Investigational Site
Bonn, 53123
Almirall Investigational Site
Cologne, 51069
Almirall Investigational Site
Cottbus, 03050
Almirall Investigational Site
Dortmund, 44263
Almirall Investigational Site
Dresden, 01307
Almirall Investigational Site
Frankfurt, 60389
Almirall Investigational Site
Frankfurt, 60596
Almirall Investigational Site
Gauting, 82131
Almirall Investigational Site
Großhansdorf, 22927
Almirall Investigational Site
Hamburg, 20253
Almirall Investigational Site
Hamburg, 20354
Almirall Investigational Site
Hamburg, 22143
Almirall Investigational Site
Hanover, 30159
Almirall Investigational Site
Jena, 07740
Almirall Investigational Site
Leipzig, 4357
Almirall Investigational Site
Marburg, 35037
Almirall Investigational Site
Munich, 80539
Almirall Investigational Site
Rüdersdorf, 15562
Almirall Investigational Site
Schwabach, 91126
Almirall Investigational Site
Wiesbaden, 65187
Almirall Investigational Site
Wiesloch, 69168
Almirall Investigational Site
Witten, 58452

Other trials in Germany

Poland17 sites

Almirall Investigational Site
Bialystok, 15-010
Almirall Investigational Site
Bialystok, 15-044
Almirall Investigational Site
Bialystok, 15-270
Almirall Investigational Site
Gdansk, 80-847
Almirall Investigational Site
Katowice, 40-752
Almirall Investigational Site
Krakow, 31-455
Almirall Investigational Site
Lodz, 90-242
Almirall Investigational Site
Ostrowiec Świętokrzyski, 27-400
Almirall Investigational Site
Piła, 64-920
Almirall Investigational Site
Poznan, 60-214
Almirall Investigational Site
Proszowice, 32-100
Almirall Investigational Site
Sopot, 81-741
Almirall Investigational Site
Szczecin, 71-124
Almirall Investigational Site
Tarnów, 33-100
Almirall Investigational Site
Tczew, 83-110
Almirall Investigational Site
Warsaw, 01-138
Almirall Investigational Site
Wilkowice-Bystra, 43-365

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Spain11 sites

Almirall Investigational Site
Alicante, 03114
Almirall Investigational Site
Barcelona, 08003
Almirall Investigational Site
Barcelona, 08025
Almirall Investigational Site
Barcelona, 08907
Almirall Investigational Site
Elda, 03600
Almirall Investigational Site
Laredo, 39770
Almirall Investigational Site
Madrid, 28007
Almirall Investigational Site
Palma de Mallorca, 07010
Almirall Investigational Site
Sant Boi de Llobregat, 08830
Almirall Investigational Site
Santander, 38008
Almirall Investigational Site
Seville, 41071

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Hungary10 sites

Almirall Investigational Site
Balassagyarmat, 2660
Almirall Investigational Site
Budapest, 1191
Almirall Investigational Site
Budapest, 1204
Almirall Investigational Site
Debrecen, H-4032
Almirall Investigational Site
Komárom, 2900
Almirall Investigational Site
Nyíregyháza, 4400
Almirall Investigational Site
Pécs, H-7635
Almirall Investigational Site
Százhalombatta, H-2400
Almirall Investigational Site
Szigetszentmiklós, H-2310
Almirall Investigational Site
Vásárosnamény, 4800

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Bulgaria8 sites

Almirall Investigational Site
Dimitrovgrad, 6400
Almirall Investigational Site
Gabrovo, 5300
Almirall Investigational Site
Kozloduy, 3320
Almirall Investigational Site
Petrich, 2850
Almirall Investigational Site
Plovdiv, 4000
Almirall Investigational Site
Razgrad, 7200
Almirall Investigational Site
Stara Zagora, 6003
Almirall Investigational Site
Vidin, 3700

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United Kingdom8 sites

Almirall Investigational Site
Birmingham, B15 2SQ
Almirall Investigational Site
Chorley, PR7 7NA
Almirall Investigational Site
Glasgow, G20 0SP
Almirall Investigational Site
Liverpool, L22 0LG
Almirall Investigational Site
Manchester, M15 6SX
Almirall Investigational Site
Middlesex, HA6 2RN
Almirall Investigational Site
Reading, RG2 0TG
Almirall Investigational Site
Sidcup, DA14 6LT

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Canada7 sites

Almirall Investigational Site
Edmonton, Alberta, AB T6G 2B7
Almirall Investigational Site
Moncton, New Brunswick, NB E1C 5K4
Almirall Investigational Site
Saint Romuald, Quebec, QC G6W 5M6
Almirall Investigational Site
Toronto, Ontario, ON M6H 3M2
Almirall Investigational Site
Trois-Rivières, Quebec, QC G8T 7A1
Almirall Investigational Site
Vancouver, British Columbia, BC V5Z 1M9
Almirall Investigational Site
Vancouver, British Columbia, BC V7M 2H9

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South Africa7 sites

Almirall Investigational Site
Belville, 7530
Almirall Investigational Site
Cape Town, 7700
Almirall Investigational Site
Gauteng, 158
Almirall Investigational Site
Gauteng, 1724
Almirall Investigational Site
Middelburg, 1050
Almirall Investigational Site
Pretoria, 0184
Almirall Investigational Site
Somerset West, 7130

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Czechia6 sites

Almirall Investigational Site
Karlovy Vary, 360 09
Almirall Investigational Site
Kralupy nad Vltavou, 278 01
Almirall Investigational Site
Liberec, 460 63
Almirall Investigational Site
Ostrava - Hrabuvka, 700 30
Almirall Investigational Site
Rokycany, 337 01
Almirall Investigational Site
Strakonice, 386 01

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Netherlands6 sites

Almirall Investigational Site
Almere Stad, 1311 RL
Almirall Investigational Site
Beek, 6191 JW
Almirall Investigational Site
Eindhoven, 5623 EJ
Almirall Investigational Site
Hoofddorp, 2134
Almirall Investigational Site
Leeuwarden, 8934 AD
Almirall Investigational Site
Rotterdam, 3045 PM

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Austria5 sites

Almirall Investigational Site
Feldbach, 8330
Almirall Investigational Site
Feldkirch, 6800
Almirall Investigational Site
Grieskirchen, A-4710
Almirall Investigational Site
Linz, 4020
Almirall Investigational Site
Salzburg, 5020

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Lithuania4 sites

Almirall Investigational Site
Kaunas, LT-50009
Almirall Investigational Site
Klaipėda, LT-92231
Almirall Investigational Site
Klaipėda, LT-92288
Almirall Investigational Site
Vilnius, LT-01117

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France3 sites

Almirall Investigational Site
Nîmes, 30900
Almirall Investigational Site
Perpignan, 66025
Almirall Investigational Site
Vieux-Condé, 59690

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Italy3 sites

Almirall Investigational Site
Pisa, 56124
Almirall Investigational Site
Pordenone, 33170
Almirall Investigational Site
Trieste, 34149

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About this study

Official title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Aclidinium Bromide / Formoterol Fumarate, Salmeterol / Fluticasone
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.

Aclidinium Bromide / Formoterol FumarateDrug
Salmeterol / FluticasoneDrug
Also called Seretide, Advair

Study groups in NCT01908140
Study group	Role	What they receive
Aclidinium Bromide / Formoterol Fumarate	Experimental	Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks Receives: Drug: Aclidinium Bromide / Formoterol Fumarate
Salmeterol / Fluticasone propionate	Active comparator	Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks Receives: Drug: Salmeterol / Fluticasone

What is being measured

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

Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
Measured: At Week 24

Secondary outcomes (1)

Transition Dyspnoea Index (TDI) Focal Score at Week 24
The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)
Measured: At Week 24

Timeline

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

Sep 2013Aug 2014

First posted25 Jul 2013 (estimated)
Study startSep 2013
Primary completionAug 2014
Study completionAug 2014

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 (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 933 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01908140
Sponsor's protocol ID: M/40464/39
Other IDs: 2013-000116-14
Status last verified: Feb 2016
First submitted: 23 Jul 2013
Last updated: 7 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.
PubMed 27492833

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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double-dummy, Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Twice-daily Aclidinium Bromide/Formoterol Fumarate Compared With Twice-daily Salmeterol/Fluticasone Propionate for 24 Weeks Treatment in Symptomatic Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01908140
Acronym / sponsor ID: M/40464/39
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 933 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 25 Jul 2013 (estimated)
Results: Posted 7 Mar 2016

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: 2

Arm	Type	Receives
Aclidinium Bromide / Formoterol Fumarate	Experimental	Drug: Aclidinium Bromide / Formoterol FumarateAclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
Salmeterol / Fluticasone propionate	Active comparator	Drug: Salmeterol / FluticasoneSalmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks

Who may qualify

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

Key inclusion criteria (6 listed)

Adult male or non-pregnant, non-lactating female aged ≥40.
Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
Patients with a clinical diagnosis of COPD according to GOLD guidelines 2013, with a post-bronchodilator FEV1 <80%, and FEV1/FVC < 70% at Screening Visits
Symptomatic patients with a COPD assessment test (CAT) ≥10 at Screening and Randomisation Visits
Patient must be able to perform repeatable pulmonary function testing for FEV1 according to ATS/ERS 2005 criteria at Screening Visits

Key exclusion criteria (20 listed)

History or current diagnosis of asthma
Development of a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit or during the run-in period
Clinically significant respiratory conditions
Type I or uncontrolled Type II diabetes, uncontrolled hypo- or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
Patients who, in the investigator's opinion, may need to start a pulmonary rehabilitation programme during the study and/or patients who started/finished it within 3 months prior to Screening Visit

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
Aclidinium Bromide / Formoterol Fumarate	Drug	Aclidinium Bromide / Formoterol Fumarate
Salmeterol / FluticasoneAlso: Seretide, Advair	Drug	Salmeterol / Fluticasone propionate

Primary outcome

Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Time frame: At Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration

1 secondary outcome

Transition Dyspnoea Index (TDI) Focal Score at Week 24
Time frame: At Week 24

Results and safety

Results posted to the registry on 7 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aclidinium Bromide / Formoterol Fumarate	468	402
Salmeterol / Fluticasone	465	386

Primary outcome: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24

Time frame: At Week 24. Least squares mean (Standard Error). Unit: Liters

Measure	Aclidinium Bromide / Formoterol Fumarate n = 389	Salmeterol / Fluticasone n = 376
Value	1.655 (0.011)	1.562 (0.011)

Aclidinium Bromide / Formoterol Fumarate vs Salmeterol / Fluticasone: Mean Difference (Final Values): 0.093 (95% CI 0.063 to 0.123), p <0.001, MMRM

Population analysed: ITT population: randomized patients who took at least one dose of IMP and have a baseline FEV1 assessment. PP population: subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 Weeks treatment + 2 weeks follow-up (±3 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aclidinium Bromide / Formoterol Fumarate	35 of 467 (7.5%)	124 of 467 (26.6%)	Not reported
Salmeterol / Fluticasone	33 of 466 (7.1%)	135 of 466 (29%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27492833Vogelmeier C, Paggiaro PL, Dorca J, Sliwinski P, Mallet M, Kirsten AM, Beier J, Seoane B, Segarra RM, Leselbaum A. Efficacy and safety of aclidinium/formoterol versus salmeterol/fluticasone: a phase 3 COPD study. Eur Respir J. 2016 Oct;48(4):1030-1039. doi: 10.1183/13993003.00216-2016. Epub 2016 Aug 4.
CSR SynopsisLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

Esther Garcia, Ph.D. study director

Global Medicines Development

126 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 20 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in Germany, Poland, Spain, Hungary, Bulgaria 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Mar 2016). 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?

Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (time frame: At Week 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 NCT01908140, 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 7 Mar 2016.