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Pulmonary Disease, Chronic ObstructivePhase 4NCT03478683

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 4 study testing budesonide/formoterol, albuterol/salbutamol and FF/UMEC/VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 57 sites in 4 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 primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC/VI [100/62.5/25 microgram (mcg)] once daily via the ELLIPTA™ compared with a multiple inhaler combination therapy of Symbicort… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
budesonide/formoterol, albuterol/salbutamol and FF/UMEC/VI
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
729 participants
Where
57 sitesin 4 countries
Study dates
25 Jun 2018to 14 Mar 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be capable of giving signed informed consent prior to study start.
  • Only outpatient subjects will be included
  • Subjects (male or female) must be 40 years of age or older at Screening (Visit 1). A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and until safety follow-up contact after the last dose of study treatment
  • An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
  • Subjects with a score of >=10 on the COPD Assessment Test (CAT) at Screening (Visit 1)
  • Subjects must demonstrate a post-bronchodilator FEV1 <50 % predicted normal or a post-bronchodilator FEV1 <80 % predicted normal and a documented history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months. Subjects must also have a measured post albuterol/salbutamol FEV1/forced vital capacity (FVC) ratio of <0.70 at screening
  • Subjects must have been receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening

Who cannot join

  • Women who are pregnant or lactating or are planning on becoming pregnant during the study
  • Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
  • Subjects with alpha 1-antitrypsin deficiency as the underlying cause of COPD
  • Subjects with active tuberculosis, lung cancer, and clinically significant: bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary diseases
  • Subjects who have undergone lung volume reduction surgery within the 12 months prior to Screening
  • Immune suppression (e.g. advanced human immunodeficiency virus [HIV] with high viral load and low cluster of differentiation 4 [CD4] count, lupus on immunosuppressants) that in the opinion of the investigator would increase risk of pneumonia or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis).
Show all 24Show fewer
  • Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral or systemic corticosteroids (if applicable)
  • Respiratory tract infection that has not resolved at least 7 days prior to Screening
  • Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest X-ray (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest X-ray at Screening Visit 1 (or historical radiograph or computerized tomography [CT] scan obtained within 3 months prior to screening). For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (BfS).
  • Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Unstable liver disease: alanine transaminase (ALT) >2 times Upper Limit of Normal (ULN); and bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %). Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • Subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure.
  • Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit 1. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead ECG tracing that is interpreted at, but not limited to, any of the following: i) Atrial Fibrillation (AF) with rapid ventricular rate >120 beats per minute (BPM); ii) Sustained and non-sustained Ventricular tachycardia (VT); iii). Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); iv) QT interval corrected for heart rate by Fridericia's formula (QTcF) >=500 milliseconds (msec) in subjects with QRS <120 msec and QTcF >=530 msec in subjects with QRS >=120 msec.
  • A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator, contraindicates study participation.
  • Subjects with carcinoma that has not been in complete remission for at least 3 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 3 year waiting period if the subject has been considered cured by treatment.
  • Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 liters per minute (L/min) at screening (Oxygen use <=3 L/min flow is not exclusionary)
  • Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
  • Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Programme within 4 weeks prior to screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
  • Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
  • Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
  • Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
  • Study Investigators, sub-Investigators, coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study
  • In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
  • Use of various medication prior to screening.

Trial locations and contacts

57 sites in 4 countries.

57 sites in 4 countries

United States40 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Baytown, Texas, 77521

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Columbia, South Carolina, 29204

  • GSK Investigational Site

    Columbus, Ohio, 43213

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Cypress, Texas, 77429

  • GSK Investigational Site

    Dayton, Ohio, 45417

  • GSK Investigational Site

    DeBary, Florida, 32713

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Edgewater, Florida, 32132

  • GSK Investigational Site

    Flint, Michigan, 48503

  • GSK Investigational Site

    Fort Mill, South Carolina, 29707

  • GSK Investigational Site

    Fridley, Minnesota, 55432

  • GSK Investigational Site

    Gold River, California, 95670

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Lancaster, South Carolina, 29720

  • GSK Investigational Site

    Miami, Florida, 33135

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33165

  • GSK Investigational Site

    Miami, Florida, 33186

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Ocala, Florida, 34470

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Peachtree Corners, Georgia, 30071

  • GSK Investigational Site

    Port Charlotte, Florida, 33952

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Portland, Oregon, 97202

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    The Bronx, New York, 10455

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

Other trials in United States

Germany7 sites

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

Other trials in Germany

Czechia5 sites

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Lovosice, 410 02

  • GSK Investigational Site

    Rokycany, 337 01

  • GSK Investigational Site

    Teplice, 415 01

Other trials in Czechia

Netherlands5 sites

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

About this study

Official title: A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC/VI [100/62.5/25 microgram (mcg)] once daily via the ELLIPTA™ compared with a multiple inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol 320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC/VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.

Being tested
budesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI, Placebo to match budesonide/formoterol, tiotropium
Keywords
long-acting muscarinic receptor antagonists, tiotropium, HRQoL, Budesonide/formoterol, chronic obstructive pulmonary disease, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • budesonide/formoterolDrug

    Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily

  • albuterol/salbutamolDrug

    Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.

  • FF/UMEC/VIDrug

    Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning

  • Placebo to match budesonide/formoterolDrug

    Subjects will be administered two inhalations of matching placebo twice daily via MDI

  • tiotropiumDrug

    Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device

  • Placebo to match FF/UMEC/VIDrug

    Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.

  • placebo to match tiotropiumDrug

    Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning

  • ELLIPTADevice

    Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.

  • MDIDevice

    Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.

  • HandiHalerDevice

    Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.

Study groups in NCT03478683
Study groupRoleWhat they receive
FF/UMEC/VI 100/62.5/25 mcgExperimentalSubjects will receive budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA during the 4-week run-in period. Subjects will be administered FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus placebo to match budesonide/formoterol via MDI, two inhalations twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning for 84 days in the treatment period.
Receives: Drug: budesonide/formoterol; Drug: albuterol/salbutamol; Drug: FF/UMEC/VI; Drug: Placebo to match budesonide/formoterol; Drug: tiotropium; Drug: placebo to match tiotropium; Device: ELLIPTA; Device: MDI; Device: HandiHaler
Budesonide/formoterol plus tiotropiumActive comparatorSubjects will receive budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA during the 4-week run-in period. Subjects will be administered budesonide/formoterol 160/4.5 mcg via MDI, two inhalations twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning for 84 days in the treatment period.
Receives: Drug: budesonide/formoterol; Drug: albuterol/salbutamol; Drug: tiotropium; Drug: Placebo to match FF/UMEC/VI; Device: ELLIPTA; Device: MDI; Device: HandiHaler

What is being measured

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

  1. Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population

    FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.

    Measured: Baseline and Week 12

  2. Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population

    FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.

    Measured: Baseline and Week 12

Secondary outcomes (2)

  1. Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85

    FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.

    Measured: Baseline, Days 2, 28, 84 and 85

  2. Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1

    FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.

    Measured: Baseline and Day 1

Timeline

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

  1. First posted27 Mar 2018
  2. Study start25 Jun 2018
  3. Primary completion14 Mar 2019
  4. Study completion14 Mar 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel group study. Eligible subjects will be randomized in a ratio of 1:1 to receive either FF/UMEC/VI single inhaler triple therapy or multiple inhaler triple combination therapy (budesonide/formoterol plus tiotropium) during the treatment period.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
729 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03478683
Sponsor's protocol ID
207608
Other IDs
2017-001149-28, 2017
Status last verified
Oct 2020
First submitted
23 Mar 2018
Last updated
28 Oct 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Ferguson GT, Brown N, Compton C, Corbridge TC, Dorais K, Fogarty C, Harvey C, Kaisermann MC, Lipson DA, Martin N, Sciurba F, Stiegler M, Zhu CQ, Bernstein D. Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials. Respir Res. 2020 May 29;21(1):131. doi: 10.1186/s12931-020-01360-w.

    PubMed 32471423

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing budesonide/formoterol, albuterol/salbutamol and FF/UMEC/VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 57 sites in 4 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 8 inclusion and 24 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Germany, Czechia, Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Feb 2020). 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?

Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 NCT03478683, 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 28 Oct 2020.

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