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Mild AsthmaPhase 3NCT02892344

Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

A Phase 3 study testing QMF149 150/80 μg and MF 200 μg in people with Mild Asthma, run by Novartis Pharmaceuticals at 123 sites in 22 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 trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. Read more about this study

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Mild Asthma
What is being tested?
QMF149 150/80 μg and MF 200 μg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
802 participants
Where
123 sitesin 22 countries
Study dates
16 Jan 2017to 30 Nov 2018
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 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
  • Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
  • Adult patients who are symptomatic at screening despite treatment with existing therapy.
  • Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
  • Adolescent patients :
  • If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
Show all 9Show fewer
  • If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
  • Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102
  • Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.

Who cannot join

  • Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
  • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
  • For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
  • For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
  • Patients who ever required intubation for a severe asthma attack/exacerbation
  • Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
Show all 14Show fewer
  • Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
  • Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
  • Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
  • Patients with Type I diabetes or uncontrolled Type II diabetes.
  • Patients with narcolepsy and/or insomnia.
  • Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
  • Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
  • Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.

Trial locations and contacts

123 sites in 22 countries.

123 sites in 22 countries

Germany13 sites

  • Novartis Investigative Site

    Bad Wörishofen, 86825

  • Novartis Investigative Site

    Berlin, 10119

  • Novartis Investigative Site

    Bochum, Germany, 44791

  • Novartis Investigative Site

    Darmstadt, 64283

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hanover, 30173

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, 04207

  • Novartis Investigative Site

    Lübeck, 23552

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, Germany, D-35037

Other trials in Germany

Slovakia13 sites

  • Novartis Investigative Site

    Banská Bystrica, SVK, 974 05

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Bratislava, 841 04

  • Novartis Investigative Site

    Čadca, Slovakia, 022 01

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Liptovský Hrádok, Slovak Republic, 033 01

  • Novartis Investigative Site

    Poprad, SVK, 058 01

  • Novartis Investigative Site

    Prešov, Slovakia, 080 01

  • Novartis Investigative Site

    Sabinov, 08301

  • Novartis Investigative Site

    Spišská Nová Ves, Slovak Republic, 052 01

  • Novartis Investigative Site

    Stropkov, Slovak Republic, 09101

  • Novartis Investigative Site

    Zvolen, Slovakia, 960 01

Other trials in Slovakia

India12 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Bangalore, Karnataka, 560099

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    Cherthala, Kerala, 688524

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045

  • Novartis Investigative Site

    Hubli, Karnataka, 580022

  • Novartis Investigative Site

    Hyderabad, Telangana, 500018

  • Novartis Investigative Site

    Mumbai, Maharashtra, 401107

  • Novartis Investigative Site

    Mysore, Karnataka, 570001

  • Novartis Investigative Site

    Nagpur, Maharashtra

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022

  • Novartis Investigative Site

    Varanasi, Uttar Pradesh, 221005

Other trials in India

South Korea8 sites

  • Novartis Investigative Site

    Anyang-si, Gyeonggi-do, 14068

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 14584

  • Novartis Investigative Site

    Busan, 612-896

  • Novartis Investigative Site

    Hwaseong-si, Gyeonggi-do, 18450

  • Novartis Investigative Site

    Seoul, Korea, 03312

  • Novartis Investigative Site

    Seoul, Seocho gu, 06591

  • Novartis Investigative Site

    Seoul, 02841

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Hungary7 sites

  • Novartis Investigative Site

    Cegléd, 2700

  • Novartis Investigative Site

    Gödöllő, 2100

  • Novartis Investigative Site

    Győr, HUN, 9024

  • Novartis Investigative Site

    Szarvas, Hungary, 5540

  • Novartis Investigative Site

    Százhalombatta, HUN, 2440

  • Novartis Investigative Site

    Szeged, Hungary, 6722

  • Novartis Investigative Site

    Törökbálint, Pest County, 2045

Other trials in Hungary

Latvia6 sites

  • Novartis Investigative Site

    Daugavpils, LV-5417

  • Novartis Investigative Site

    Jūrmala, LVA, LV-2015

  • Novartis Investigative Site

    Riga, LV, 1011

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Riga, LV-1001

  • Novartis Investigative Site

    Riga, LV-1004

Other trials in Latvia

Russia6 sites

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Rostov-on-Don, 344011

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 196240

  • Novartis Investigative Site

    Yekaterinburg, 620028

Other trials in Russia

South Africa6 sites

  • Novartis Investigative Site

    Belleville, South Africa, 7530

  • Novartis Investigative Site

    Cape Town, ZAF, 7570

  • Novartis Investigative Site

    Cape Town, 7531

  • Novartis Investigative Site

    Middelburg, Mpumalanga, 1050

  • Novartis Investigative Site

    Panorama, 7550

  • Novartis Investigative Site

    Winnie Mandela, Free State, 8340

Other trials in South Africa

Colombia5 sites

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110911

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Bucaramanga, Colombia

  • Novartis Investigative Site

    Medellín, Antioquia, 0050010

  • Novartis Investigative Site

    Medellín, Colombia

Other trials in Colombia

Italy5 sites

  • Novartis Investigative Site

    Cassano delle Murge, BA, 70020

  • Novartis Investigative Site

    Fiumicino, RM, 00054

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, Italy, 16147

  • Novartis Investigative Site

    Roma, 00161

Other trials in Italy

Japan5 sites

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 103 0027

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0027

  • Novartis Investigative Site

    Setagaya-ku, Tokyo, 157006

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 162-0053

  • Novartis Investigative Site

    Toshima-ku, Tokyo, 171-0014

Other trials in Japan

Peru5 sites

  • Novartis Investigative Site

    Cusco, 84

  • Novartis Investigative Site

    Lima, 10

  • Novartis Investigative Site

    Lima, 14

  • Novartis Investigative Site

    Piura, 2000

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33

Other trials in Peru

Chile4 sites

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500692

  • Novartis Investigative Site

    Santiago, 8380453

  • Novartis Investigative Site

    Santiago

  • Novartis Investigative Site

    Viña del Mar, 2520594

Other trials in Chile

Estonia4 sites

  • Novartis Investigative Site

    Kohtla-Järve, 30322

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, Estonia, 51014

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Malaysia4 sites

  • Novartis Investigative Site

    Alor Star, Kedah, 05460

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400

  • Novartis Investigative Site

    Putrajaya, 62250

  • Novartis Investigative Site

    Taiping, Perak, 34000

Other trials in Malaysia

Poland4 sites

  • Novartis Investigative Site

    Bialystok, 15-044

  • Novartis Investigative Site

    Biaystok, Poland, 15-430

  • Novartis Investigative Site

    Grudziądz, 86-300

  • Novartis Investigative Site

    Katowice, 40 085

Other trials in Poland

Bulgaria3 sites

  • Novartis Investigative Site

    Bulgaria, Bulgaria

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Stara Zagora, Bulgaria, 6000

Other trials in Bulgaria

Philippines3 sites

  • Novartis Investigative Site

    Iloilo City, Iloilo, 5000

  • Novartis Investigative Site

    Manila, 1008

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

Sweden3 sites

  • Novartis Investigative Site

    Linköping, Östergötland County, 587 58

  • Novartis Investigative Site

    Stockholm, 111 57

  • Novartis Investigative Site

    Uppsala, 75237

Other trials in Sweden

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, Thailand, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Lithuania2 sites

  • Novartis Investigative Site

    Vilnius, 8109

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Vietnam2 sites

  • Novartis Investigative Site

    Haiphong, 180000

  • Novartis Investigative Site

    Ho Chi Minh City, VNM, 700000

Other trials in Vietnam

About this study

Official title: A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma

The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.

delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.

Read the detailed description

The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.

Conditions
Mild Asthma
Being tested
QMF149 150/80 μg, MF 200 μg
Keywords
Phase III, blinded, QMF149, Mometasone furoate (MF), mild asthma, Adolescent, adult

What participants receive

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

  • QMF149 150/80 μgDrug

    Also called Indacaterol acetate/Mometasone furoate

    QMF149 150/80 μg o.d via Concept1

  • MF 200 μgDrug

    Also called Mometasone furoate

    MF 200 μg o.d. via Twisthaler®

Study groups in NCT02892344
Study groupRoleWhat they receive
QMF149 150/80 μgExperimentalQMF149 150/80 microgram o.d. delivered via Concept1
Receives: Drug: QMF149 150/80 μg
MF 200 µgActive comparatorMF 200 microgram o.d. delivered via Twisthaler®
Receives: Drug: MF 200 μg

What is being measured

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

  1. Trough FEV1

    demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.

    Measured: week 12

Secondary outcomes (14)

  1. ACQ-7

    ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment.

    Measured: week 12

  2. Trough FEV1 at Day 2

    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing

    Measured: Day 2

  3. Pre-dose FEV1 at Week 4

    Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose

    Measured: week 4

  4. FVC Over 12 Weeks

    FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured

    Measured: week 12

  5. PEF Over 4 and 12 Weeks

    Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration

    Measured: week 12

  6. Percentage of Patients With ACQ-7 MID at Week 12

    MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured.

    Measured: week 12

  7. Daily E-diary Over 12 Weeks

    Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment

    Measured: week 12

  8. ACQ-7 at Week 4

    ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control

    Measured: week 4

  9. Rescue Medication Use Over 12 Weeks

    Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment

    Measured: week 12

  10. Percentage of Rescue Medication Free Days Over 12 Weeks

    Percentage of rescue medication free days over 12 weeks of treatment period

    Measured: week 12

  11. Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12

    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

    Measured: week 12

  12. Number of Patients With Asthma Exacerbation Over 12 Weeks

    The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category.

    Measured: Week 12

  13. The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period

    Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations

    Measured: Week 12

  14. Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period

    The annual rate of asthma exacerbations were analyzed using a generalized linear model.

    Measured: Week 12

Timeline

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

  1. First posted8 Sep 2016 (estimated)
  2. Study start16 Jan 2017
  3. Primary completion5 Nov 2018
  4. Study completion30 Nov 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
802 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892344
Sponsor's protocol ID
CQVM149B2303
Other IDs
2016-000472-22, 2016
Status last verified
Dec 2025
First submitted
29 Aug 2016
Last updated
13 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PubMed 36472162

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QMF149 150/80 μg and MF 200 μg in people with Mild Asthma, run by Novartis Pharmaceuticals at 123 sites in 22 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 14 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in Germany, Slovakia, India, South Korea, Hungary and 17 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 12 Sep 2019). 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?

Trough FEV1 (time frame: week 12). 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 NCT02892344, 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 13 Jan 2026.

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