Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

February 7, 2017 updated by: Pearl Therapeutics, Inc.

A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia
        • Pearl Investigative Site
      • Westmead, New South Wales, Australia
        • Pearl Investigative Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Pearl Investigative Site
      • Cairns, Queensland, Australia
        • Pearl Investigative Site
      • Wooloongabba, Queensland, Australia
        • Pearl Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Pearl Investigative Site
      • Daw Park, South Australia, Australia
        • Pearl Investigative Site
      • Toorak Gardens, South Australia, Australia
        • Pearl Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Pearl Investigative Site
      • Heidelberg, Victoria, Australia
        • Pearl Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Pearl Investigative Site
      • Perth, Western Australia, Australia
        • Pearl Investigative Site
  • New Zealand
      • Tauranga, New Zealand
        • Pearl Investigative Site
    • Aukland
      • Otahuhu, Aukland, New Zealand
        • Pearl Investigative Site
    • Dunedin
      • Caversham, Dunedin, New Zealand
        • Pearl Investigative Site
    • East Aukland
      • Greenlane, East Aukland, New Zealand
        • Pearl Investigative Site
    • Waikato
      • Hamilton, Waikato, New Zealand
        • Pearl Investigative Site
    • Wellington
      • Newtown, Wellington, New Zealand
        • Pearl Investigative Site
  • United States
    • Alabama
      • Andalusia, Alabama, United States
        • Pearl Investigative Site
      • Anniston, Alabama, United States
        • Pearl Investigative Site
      • Athens, Alabama, United States
        • Pearl Investigative Site
      • Birmingham, Alabama, United States
        • Pearl Investigative Site
    • Arizona
      • Mesa, Arizona, United States
        • Pearl Investigative Site
      • Phoenix, Arizona, United States
        • Pearl Investigative Site
      • Scottsdale, Arizona, United States
        • Pearl Investigative Site
      • Tucson, Arizona, United States
        • Pearl Investigative Site
    • California
      • Anaheim, California, United States
        • Pearl Investigative Site
      • Carlsbad, California, United States
        • Pearl Investigative Site
      • Lakewood, California, United States
        • Pearl Investigative Site
      • Los Angeles, California, United States
        • Pearl Investigative Site
      • Pasadena, California, United States
        • Pearl Investigative Site
      • Pasedena, California, United States
        • Pearl Investigative Site
      • Poway, California, United States
        • Pearl Investigative Site
      • Sacramento, California, United States
        • Pearl Investigative Site
      • San Diego, California, United States
        • Pearl Investigative Site
      • Tustin, California, United States
        • Pearl Investigative Site
      • Vista, California, United States
        • Pearl Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Pearl Investigative Site
      • Denver, Colorado, United States
        • Pearl Investigative Site
      • Fort Collins, Colorado, United States
        • Pearl Investigative Site
      • Wheat Ridge, Colorado, United States
        • Pearl Investigative Site
    • Connecticut
      • Danbury, Connecticut, United States
        • Pearl Investigative Site
      • Waterbury, Connecticut, United States
        • Pearl Investigative Site
    • Florida
      • Brandon, Florida, United States
        • Pearl Investigative Site
      • Clearwater, Florida, United States
        • Pearl Investigative Site
      • Lehigh Acres, Florida, United States
        • Pearl Investigative Site
      • Miami, Florida, United States
        • Pearl Investigative Site
      • Ormond Beach, Florida, United States
        • Pearl Investigative Site
      • Panama City, Florida, United States
        • Pearl Investigative Site
      • Pensacola, Florida, United States
        • Pearl Investigative Site
      • St. Petersburg, Florida, United States
        • Pearl Investigative Site
      • Tampa, Florida, United States
        • Pearl Investigative Site
      • Winter Park, Florida, United States
        • Pearl Investigative Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pearl Investigative Site
      • Austell, Georgia, United States
        • Pearl Investigative Site
      • Columbus, Georgia, United States
        • Pearl Investigative Site
      • Duluth, Georgia, United States
        • Pearl Investigative Site
      • Gainesville, Georgia, United States
        • Pearl Investigative Site
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • Pearl Investigative Site
    • Illinois
      • Champaign, Illinois, United States
        • Pearl Investigative Site
      • Evanston, Illinois, United States
        • Pearl Investigative Site
      • Peoria, Illinois, United States
        • Pearl Investigative Site
      • River Forest, Illinois, United States
        • Pearl Investigative Site
    • Indiana
      • Anderson, Indiana, United States
        • Pearl Investigative Site
      • Avon, Indiana, United States
        • Pearl Investigative Site
      • Elwood, Indiana, United States
        • Pearl Investigative Site
      • Evansville, Indiana, United States
        • Pearl Investigative Site
    • Iowa
      • Iowa City, Iowa, United States
        • Pearl Investigative Site
    • Kansas
      • Topeka, Kansas, United States
        • Pearl Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Pearl Investigative Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • Pearl Investigative Site
      • Sunset, Louisiana, United States
        • Pearl Investigative Site
    • Maryland
      • Baltimore, Maryland, United States
        • Pearl Investigative Site
      • Hollywood, Maryland, United States
        • Pearl Investigative Site
    • Michigan
      • Livonia, Michigan, United States
        • Pearl Investigative Site
      • Southfield, Michigan, United States
        • Pearl Investigative Site
    • Minnesota
      • Edina, Minnesota, United States
        • Pearl Investigative Site
      • Fridley, Minnesota, United States
        • Pearl Investigative Site
      • Minneapolis, Minnesota, United States
        • Pearl Investigative Site
      • Woodbury, Minnesota, United States
        • Pearl Investigative Site
    • Missouri
      • Springfield, Missouri, United States
        • Pearl Investigative Site
      • St Louis, Missouri, United States
        • Pearl Investigative Site
      • St. Charles, Missouri, United States
        • Pearl Investigative Site
    • Montana
      • Missoula, Montana, United States
        • Pearl Investigative Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • Pearl Investigative Site
      • Omaha, Nebraska, United States
        • Pearl Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Pearl Investigative Site
    • New Jersey
      • Ocean, New Jersey, United States
        • Pearl Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Pearl Investigative Site
    • New York
      • Corning, New York, United States
        • Pearl Investigative Site
    • North Carolina
      • Burlington, North Carolina, United States
        • Pearl Investigative Site
      • Charlotte, North Carolina, United States
        • Pearl Investigative Site
      • Greensboro, North Carolina, United States
        • Pearl Investigative Site
      • Huntersville, North Carolina, United States
        • Pearl Investigative Site
      • Raleigh, North Carolina, United States
        • Pearl Investigative Site
      • Wilmington, North Carolina, United States
        • Pearl Investigative Site
      • Winston-Salem, North Carolina, United States
        • Pearl Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pearl Investigative Site
      • Columbus, Ohio, United States
        • Pearl Investigative Site
      • Dayton, Ohio, United States
        • Pearl Investigative Site
      • Dublin, Ohio, United States
        • Pearl Investigative Site
      • Oregon, Ohio, United States
        • Pearl Investigative Site
    • Oregon
      • Bend, Oregon, United States
        • Pearl Investigative Site
      • Medford, Oregon, United States
        • Pearl Investigative Site
      • Portland, Oregon, United States
        • Pearl Investigative Site
    • Pennsylvania
      • Monroeville, Pennsylvania, United States
        • Pearl Investigative Site
      • Philadelphia, Pennsylvania, United States
        • Pearl Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Pearl Investigative Site
      • Easley, South Carolina, United States
        • Pearl Investigative Site
      • Gaffney, South Carolina, United States
        • Pearl Investigative Site
      • Greenville, South Carolina, United States
        • Pearl Investigative Site
      • Mt. Pleasant, South Carolina, United States
        • Pearl Investigative Site
      • Murrells Inlet, South Carolina, United States
        • Pearl Investigative Site
      • Myrtle Beach, South Carolina, United States
        • Pearl Investigative Site
      • Rock Hill, South Carolina, United States
        • Pearl Investigative Site
      • Spartanburg, South Carolina, United States
        • Pearl Investigative Site
      • Union, South Carolina, United States
        • Pearl Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Pearl Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States
        • Pearl Investigative Site
      • Johnson City, Tennessee, United States
        • Pearl Investigative Site
      • Kingsport, Tennessee, United States
        • Pearl Investigative Site
      • Tullahoma, Tennessee, United States
        • Pearl Investigative Site
    • Texas
      • Austin, Texas, United States
        • Pearl Investigative Site
      • El Paso, Texas, United States
        • Pearl Investigative Site
      • Fort Worth, Texas, United States
        • Pearl Investigative Site
      • Houston, Texas, United States
        • Pearl Investigative Site
      • Huntsville, Texas, United States
        • Pearl Investigative Site
      • Longview, Texas, United States
        • Pearl Investigative Site
      • Lufkin, Texas, United States
        • Pearl Investigative Site
      • New Braunfels, Texas, United States
        • Pearl Investigative Site
      • San Antonio, Texas, United States
        • Pearl Investigative Site
    • Utah
      • Midvale, Utah, United States
        • Pearl Investigative Site
      • Salt Lake City, Utah, United States
        • Pearl Investigative Site
    • Vermont
      • South Burlington, Vermont, United States
        • Pearl Investigative Site
    • Virginia
      • Abingdon, Virginia, United States
        • Pearl Investigative Site
      • Richmond, Virginia, United States
        • Pearl Investigative Site
    • Washington
      • Spokane, Washington, United States
        • Pearl Investigative Site
      • Tacoma, Washington, United States
        • Pearl Investigative Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Pearl Investigative Site
    • Wisconsin
      • West Allis, Wisconsin, United States
        • Pearl Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
  • Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
  • Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
  • Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

  • Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
  • Current diagnosis of asthma or alpha-1 antitrypsin deficiency
  • Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
  • Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
  • Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
  • Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
  • Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
  • Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
  • Congestive heart failure (CHF) New York Heart Association (NYHA) Class III/IV)
  • Clinically significant abnormal 12-lead ECG
  • Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
  • Cancer not in complete remission for at least five years
  • History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GFF MDI
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
Drug: GFF MDI
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
Experimental: GP MDI
Glycopyrronium (GP) MDI (PT001)
Drug: GP MDI
GP MDI administered as two puffs BID
Experimental: FF MDI
Formoterol Fumarate (FF) MDI (PT005)
Drug: FF MDI
FF MDI administered as two puffs BID
Active Comparator: Open-label tiotropium bromide inhalation powder
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Placebo Comparator: Placebo
Placebo MDI
Drug: Placebo MDI
Inhaled placebo administered as two puffs BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Time Frame: Baseline and at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Baseline and at Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Time Frame: Baseline and Weeks 2 to 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Baseline and Weeks 2 to 24
St. George's Respiratory Questionnaire (SGRQ) Score
Time Frame: Baseline and at Week 24
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Baseline and at Week 24
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Time Frame: Baseline and at Week 24
Change from baseline in average daily rescue Ventolin HFA use
Baseline and at Week 24
Onset of Action as Assessed by FEV1
Time Frame: Assessed for 5- and 15-minute post dose on Day 1
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Assessed for 5- and 15-minute post dose on Day 1
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Time Frame: Baseline and at Week 24
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Baseline and at Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Colin Reisner, MD, Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT003006-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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