Chronic Obstructive Pulmonary Disease - COPDPhase 2NCT02796651
Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)
A Phase 2 study testing Formoterol fumarate (6 μg), Formoterol furmarate (20 μg) and Formoterol fumarate (12 μg) in people with Chronic Obstructive Pulmonary Disease - COPD, run by AstraZeneca at 20 sites in United States.
Trial summary
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg). Read more about this study
- Who is it for?
- Ages 40 to 130 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease - COPD
- What is being tested?
- Formoterol fumarate (6 μg), Formoterol furmarate (20 μg) and Formoterol fumarate (12 μg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Jun 2016to 7 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or non-pregnant, non-lactating female patients aged ≥40.
- Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1.
- Patients with moderate to severe stable COPD: post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Visit 1.
- Patients with reversible airway obstruction defined as an increase in FEV1 of at least 12% and 200 mL over the baseline value after four inhalations of albuterol sulfate 108 µg via a pMDI at Visit 1.
- Current or former-smokers, with a smoking history of ≥ 10 pack-years.
- Patients able to perform acceptable and repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2005 criteria at Visit 1.
- Patients eligible and able to participate in the study and who had signed an Informed Consent Form prior to initiation of any study-related procedures.
Who cannot join
- Patients with asthma.
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to Visit 1 or during the run-in period.
- Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Visit 1.
- Clinically significant respiratory conditions other than COPD.
- Patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Visit 1.
- Use of long-term oxygen therapy (≥ 15 hours/day).
Show all 23Show fewer
- Patients who do not maintain regular day/night, waking/sleeping cycles including night shift workers.
- Clinically significant cardiovascular conditions.
- Patients with uncontrolled Type I or Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled hypertension.
- Patients with history of long QT syndrome or whose QTc (calculated according to Fridericia's Formula QTc=QT/RR1/3) > 470 ms as indicated in the centralized reading report assessed at Visit 1.
- Patients with clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at Visit 1 that might compromise patient safety.
- Patients with a history of hypersensitivity reaction to an inhaled medication or any component thereof, including paradoxical bronchospasm.
- Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention or symptomatic unstable prostate hypertrophy.
- 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.
- Patients with any other serious or uncontrolled physical or mental dysfunction.
- Patients with a history (within 2 years prior to screening) of drug and/or alcohol abuse that may prevent study compliance based on the Investigator judgment.
- Patients unlikely to be cooperative or who cannot comply with the study procedures.
- Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1.
- Patients who intended to use any concomitant medication not permitted by this protocol or who had not undergone the required washout period for a particular prohibited medication.
- Patients unable to give consent, or patients of consenting age but under guardianship, or vulnerable patients.
- Any other conditions that, in the investigator's opinion, might render the patient to be unsuitable for the study.
- Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or site staff), or patients employed by or relatives of the employees of the site or sponsor.
- Previous randomization in the present study D6571C00002.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Research Site
Boerne, Texas, 78006
Research Site
Celebration, Florida, 34747
Research Site
Charlotte, North Carolina, 28207
Research Site
Clearwater, Florida, 33756
Research Site
DeLand, Florida, 32720
Research Site
Easley, South Carolina, 29640
Research Site
Gastonia, North Carolina, 28054
Research Site
Glendale, Arizona, 85306
Research Site
Greenville, South Carolina, 29615
Research Site
Killeen, Texas, 76543
Research Site
Las Vegas, Nevada, 89102
Research Site
Lawrenceville, Georgia, 30046
Research Site
Medford, Oregon, 97504
Research Site
Orlando, Florida, 32825
Research Site
Phoenix, Arizona, 85006
Research Site
Portland, Oregon, 97202
Research Site
Rock Hill, South Carolina, 29372
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63141
Research Site
Tempe, Arizona, 85283
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
Read the detailed description
This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.
- Being tested
- Formoterol fumarate (6 μg), Formoterol furmarate (20 μg), Placebo for formoterol fumarate, Formoterol fumarate (12 μg), Formoterol fumarate (40 μg)
- Keywords
- Perforomist, Pressair, COPD, Cigarette smoking, Formoterol fumarate, long-acting β2-adrenergic agonists (LABA), long-acting muscarinic antagonists (LAMA)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol fumarate (6 μg)Drug
Also called Formoterol (Pressair®)
Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol furmarate (20 μg)Drug
Also called Perforomist® Inhalation Solution
Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
Placebo for formoterol fumarateDrug
Also called Placebo (Pressair®)
Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol fumarate (12 μg)Drug
Also called Formoterol (Pressair®)
Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol fumarate (40 μg)Drug
Also called Perforomist® Inhalation Solution
Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
| Study group | Role | What they receive |
|---|---|---|
| Formoterol 6 μg | Experimental | Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID). Receives: Drug: Formoterol fumarate (6 μg) |
| Formoterol 12 μg | Experimental | Participants received formoterol fumarate 12 μg administered via Pressair BID. Receives: Drug: Formoterol fumarate (12 μg) |
| Formoterol 24 μg | Experimental | Participants received formoterol fumarate 24 μg administered via Pressair BID. Receives: Drug: Formoterol fumarate (12 μg) |
| Placebo | Placebo comparator | Participants received placebo to formoterol fumarate administered via Pressair BID. Receives: Drug: Placebo for formoterol fumarate |
| Formoterol 20 μg | Experimental | Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days. Receives: Drug: Formoterol furmarate (20 μg) |
| Formoterol 40 μg | Experimental | Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration. Receives: Drug: Formoterol fumarate (40 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).
Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.
Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Measured: Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose
Secondary outcomes (3)
Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.
Measured: Day 1: zero time to 6 hours post-dose
Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation
Measured: Day 7: zero time to 6 hours post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.
Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
Measured: At baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion7 Dec 2016
- Study completion7 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease - COPDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Mark H. Gotfried, MD, Principal investigator, 1112 East McDowell Road, Phoenix, AZ 85006, United States.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796651
- Sponsor's protocol ID
- D6571C00002
- Status last verified
- Jan 2018
- First submitted
- 7 Jun 2016
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.
- ClinicalTrials.gov ID
- NCT02796651
- Acronym / sponsor ID
- D6571C00002
- Keywords
- Perforomist, Pressair, COPD, Cigarette smoking, Formoterol fumarate, long-acting β2-adrenergic agonists (LABA), long-acting muscarinic antagonists (LAMA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).
Detailed description
This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Formoterol 6 μg | Experimental | Drug: Formoterol fumarate (6 μg)Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID). |
| Formoterol 12 μg | Experimental | Drug: Formoterol fumarate (12 μg)Participants received formoterol fumarate 12 μg administered via Pressair BID. |
| Formoterol 24 μg | Experimental | Drug: Formoterol fumarate (12 μg)Participants received formoterol fumarate 24 μg administered via Pressair BID. |
| Placebo | Placebo comparator | Drug: Placebo for formoterol fumarateParticipants received placebo to formoterol fumarate administered via Pressair BID. |
| Formoterol 20 μg | Experimental | Drug: Formoterol furmarate (20 μg)Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days. |
| Formoterol 40 μg | Experimental | Drug: Formoterol fumarate (40 μg)Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration. |
Who may qualify
- Ages
- 40 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male or non-pregnant, non-lactating female patients aged ≥40.
- Patients with a diagnosis of COPD (GOLD guidelines, 2016) for a period of at least 6 months prior to Visit 1.
- Patients with moderate to severe stable COPD: post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal and post-bronchodilator FEV1/FVC < 70% at Visit 1.
- Patients with reversible airway obstruction defined as an increase in FEV1 of at least 12% and 200 mL over the baseline value after four inhalations of albuterol sulfate 108 µg via a pMDI at Visit 1.
- Current or former-smokers, with a smoking history of ≥ 10 pack-years.
Key exclusion criteria (23 listed)
- Patients with asthma.
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to Visit 1 or during the run-in period.
- Patients hospitalized for a COPD exacerbation (an emergency room visit for longer than 24 hours is considered a hospitalization) within 3 months prior to Visit 1.
- Clinically significant respiratory conditions other than COPD.
- Patients who in the investigator's opinion may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Visit 1.
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 |
|---|---|---|
| Formoterol fumarate (6 μg)Also: Formoterol (Pressair®)Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) | Drug | Formoterol 6 μg |
| Formoterol furmarate (20 μg)Also: Perforomist® Inhalation SolutionOral Inhalation (via a standard jet nebulizer connected to an air compressor. | Drug | Formoterol 20 μg |
| Placebo for formoterol fumarateAlso: Placebo (Pressair®)Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) | Drug | Placebo |
| Formoterol fumarate (12 μg)Also: Formoterol (Pressair®)Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) | Drug | Formoterol 12 μg, Formoterol 24 μg |
| Formoterol fumarate (40 μg)Also: Perforomist® Inhalation SolutionOral Inhalation (via a standard jet nebulizer connected to an air compressor. | Drug | Formoterol 40 μg |
Primary outcome
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment
Time frame: Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose
To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg). Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them. Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.
3 secondary outcomes
Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment
Time frame: Day 1: zero time to 6 hours post-dose
Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment
Time frame: Day 7: zero time to 6 hours post-dose
Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment
Time frame: At baseline and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark H. Gotfried, MD principal investigator
1112 East McDowell Road, Phoenix, AZ 85006, United States.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formoterol fumarate (6 μg), Formoterol furmarate (20 μg) and Formoterol fumarate (12 μg) in people with Chronic Obstructive Pulmonary Disease - COPD, run by AstraZeneca at 20 sites in United States.
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 7 inclusion and 23 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2018). 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?
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment (time frame: Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2018.