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QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

indacaterol and glycopyrronium (QVA149)

Placebo to fluticasone/salmeterol

fluticasone/salmeterol

Placebo to indacaterol and glycopyrronium (QVA149)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring QVA149, indacaterol, NVA237, COPD, fluticasone/salmeterol

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Smoking history of at least 10 pack years
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Exclusion Criteria:

Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer (within last 5 years)
Patients with a history of certain cardiovascular co-morbid conditions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

fluticasone/salmeterol

Arm Description

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Outcomes

Primary Outcome Measures

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.

Secondary Outcome Measures

Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.

Forced Vital Capacity at All-time Points (Week 12)

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model.

Forced Vital Capacity at All-time Points (Week 26)

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.

Focal Score of the Transitional Dyspnea Index (TDI)

Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.

Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)

The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.

Mean Change From Baseline in Daily Number of Puffs of Rescue Medication

Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.

Change From Baseline in Symptom Scores Reported Using the Ediary

Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use. Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked. 0 is the minimum score = "none" or "No symptoms" or "never" or "No" = mild, a little = moderate = severe For the scale range provided, high values represent a worse outcome.

Inspiratory Capacity (IC) at All-time Points (12 Weeks)

After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

Inspiratory Capacity (IC) at All-time Points (26 Weeks)

After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

Number of Participants With Adverse Events

The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.

Full Information

NCT ID

NCT01315249

First Posted

March 11, 2011

Last Updated

July 9, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01315249

Brief Title

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Acronym

ILLUMINATE

Official Title

A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

QVA149, indacaterol, NVA237, COPD, fluticasone/salmeterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

523 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Arm Title

fluticasone/salmeterol

Arm Type

Active Comparator

Arm Description

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Intervention Type

Drug

Intervention Name(s)

indacaterol and glycopyrronium (QVA149)

Intervention Description

QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo to fluticasone/salmeterol

Intervention Description

Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.

Intervention Type

Drug

Intervention Name(s)

fluticasone/salmeterol

Intervention Description

Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.

Intervention Type

Drug

Intervention Name(s)

Placebo to indacaterol and glycopyrronium (QVA149)

Intervention Description

Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Primary Outcome Measure Information:

Title

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12

Description

Time Frame

Week 26

Secondary Outcome Measure Information:

Title

Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

Description

Time Frame

Week 12

Title

Forced Vital Capacity at All-time Points (Week 12)

Description

Time Frame

-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12

Title

Forced Vital Capacity at All-time Points (Week 26)

Description

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model.

Time Frame

-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26

Title

Focal Score of the Transitional Dyspnea Index (TDI)

Description

Time Frame

12 weeks and 26 weeks

Title

Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)

Description

Time Frame

12 weeks and 26 weeks

Title

Mean Change From Baseline in Daily Number of Puffs of Rescue Medication

Description

Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.

Time Frame

Baseline, 12 weeks and 26 weeks

Title

Change From Baseline in Symptom Scores Reported Using the Ediary

Description

Time Frame

12 weeks and 26 weeks

Title

Inspiratory Capacity (IC) at All-time Points (12 Weeks)

Description

Time Frame

12 weeks

Title

Inspiratory Capacity (IC) at All-time Points (26 Weeks)

Description

Time Frame

26 weeks

Title

Number of Participants With Adverse Events

Description

The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Smoking history of at least 10 pack years Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009) Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70% Exclusion Criteria: Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year. Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1. Patients with concomitant pulmonary disease Patients with a history of asthma Any patient with lung cancer or a history of lung cancer (within last 5 years) Patients with a history of certain cardiovascular co-morbid conditions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jambes

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jette

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Luxembourg

ZIP/Postal Code

1210

Country

Belgium

Facility Name

Novartis Investigative Site

City

Malmedy

ZIP/Postal Code

4960

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kyjov

State/Province

CZE

ZIP/Postal Code

697 70

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Cvikov

ZIP/Postal Code

471 54

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

JIndrichuv Hradec

ZIP/Postal Code

377 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Melnik

ZIP/Postal Code

276 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

530 09

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Prague 3

ZIP/Postal Code

130 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

108 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Teplice

ZIP/Postal Code

415 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Woerishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13057

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13086

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13581

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14050

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

D-12165

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33617

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Borstel

ZIP/Postal Code

23845

Country

Germany

Facility Name

Novartis Investigative Site

City

Dueren

ZIP/Postal Code

52349

Country

Germany

Facility Name

Novartis Investigative Site

City

Eschwege

ZIP/Postal Code

37269

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Freudenberg

ZIP/Postal Code

57258

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36039

Country

Germany

Facility Name

Novartis Investigative Site

City

Fürstenwalde/Spree

ZIP/Postal Code

15517

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Novartis Investigative Site

City

Gummersbach

ZIP/Postal Code

51643

Country

Germany

Facility Name

Novartis Investigative Site

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Güstrow

ZIP/Postal Code

18273

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

59065

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Novartis Investigative Site

City

Lübeck

ZIP/Postal Code

23558

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80539

Country

Germany

Facility Name

Novartis Investigative Site

City

Oschersleben

ZIP/Postal Code

39387

Country

Germany

Facility Name

Novartis Investigative Site

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Novartis Investigative Site

City

Rheine

ZIP/Postal Code

48431

Country

Germany

Facility Name

Novartis Investigative Site

City

Saarbrücken

ZIP/Postal Code

66111

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerte

ZIP/Postal Code

58239

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42651

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wissen

ZIP/Postal Code

57537

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1191

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cegled

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mosonmagyarovar

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6770

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Wonju

State/Province

Gangwon

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

100-032

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

130-702

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

130-709

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Alytus

ZIP/Postal Code

LT-62114

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

44320

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Utena

ZIP/Postal Code

LT-28151

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

06001

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kongsvinger

ZIP/Postal Code

2212

Country

Norway

Facility Name

Novartis Investigative Site

City

Skedsmokorset

ZIP/Postal Code

2020

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Novartis Investigative Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Novartis Investigative Site

City

Ålesund

ZIP/Postal Code

6017

Country

Norway

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Cataluña

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Boi de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08830

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

ZIP/Postal Code

03114

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

ZIP/Postal Code

47011

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24321804

Citation

Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6. Erratum In: Lancet Respir Med. 2013 Apr;1(2):101.

Results Reference

derived

Learn more about this trial

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial