Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO)

April 30, 2019 updated by: AstraZeneca

A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO)

This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients 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.
1119

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

  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Research Site
      • Dupnitsa, Bulgaria, 2602
        • Research Site
      • Haskovo, Bulgaria, 6305
        • Research Site
      • Kozloduy, Bulgaria, 3320
        • Research Site
      • Pazardzhik, Bulgaria, 4400
        • Research Site
      • Petrich, Bulgaria, 2850
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Razlog, Bulgaria, 2760
        • Research Site
      • Ruse, Bulgaria, 7002
        • Research Site
      • Sliven, Bulgaria, 8800
        • Research Site
      • Smolyan, Bulgaria, 4700
        • Research Site
      • Sofia, Bulgaria, 1407
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1618
        • Research Site
      • Sofia, Bulgaria, 1002
        • Research Site
      • Sofia, Bulgaria, 1408
        • Research Site
      • Stara Zagora, Bulgaria, 6000
        • Research Site
      • Varna, Bulgaria, 9000
        • Research Site
      • Vidin, Bulgaria, 3700
        • Research Site
  • Canada
      • Quebec, Canada, G1G 3Y8
        • Research Site
      • Quebec, Canada, G1V 4G5
        • Research Site
      • Quebec, Canada, G3K 2P8
        • Research Site
    • Alberta
      • Sherwood Park, Alberta, Canada, T8L 0N2
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • Research Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • Research Site
      • Etobicoke, Ontario, Canada, M9W 4L6
        • Research Site
      • Windsor, Ontario, Canada, N8X 1T3
        • Research Site
      • Windsor, Ontario, Canada, N8X-5A6
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • Research Site
      • Levis, Quebec, Canada, G6W 0M5
        • Research Site
      • St Charles Borromee, Quebec, Canada, J6E 2B4
        • Research Site
  • France
      • Besancon Cedex, France, 25030
        • Research Site
      • Brest Cedex, France, 29609
        • Research Site
      • Lyon Cedex 04, France, 69317
        • Research Site
      • Montpellier, France, 34295
        • Research Site
      • Nantes Cedex 2, France, 44277
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Reims, France, 51092
        • Research Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Research Site
      • Budapest, Hungary, 1135
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Debrecen, Hungary, H-4031
        • Research Site
      • Farkasgyepü, Hungary, 8582
        • Research Site
      • Hajdúnánás, Hungary, 4080
        • Research Site
      • Komló, Hungary, 7300
        • Research Site
      • Komárom, Hungary, 2900
        • Research Site
      • Miskolc, Hungary, 3529
        • Research Site
      • Püspökladány, Hungary, 4150
        • Research Site
      • Siófok, Hungary, 8600
        • Research Site
      • Szeged, Hungary, H-6722
        • Research Site
      • Szombathely, Hungary, 9700
        • Research Site
      • Vásárosnamény, Hungary, 4800
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Research Site
      • Barnaul, Russian Federation, 656038
        • Research Site
      • Chelyabinsk, Russian Federation, 454021
        • Research Site
      • Ekaterinburg, Russian Federation, 620028
        • Research Site
      • Izhevsk, Russian Federation, 426035
        • Research Site
      • Moscow, Russian Federation, 109544
        • Research Site
      • Novosibirsk, Russian Federation, 630051
        • Research Site
      • Penza, Russian Federation, 440026
        • Research Site
      • Penza, Russian Federation, 440067
        • Research Site
      • Ryazan, Russian Federation, 390005
        • Research Site
      • Saint Petersburg, Russian Federation, 197342
        • Research Site
      • Saint Petersburg, Russian Federation, 198260
        • Research Site
      • Saint Petersburg, Russian Federation, 191015
        • Research Site
      • Saint-Petersburg, Russian Federation, 194291
        • Research Site
      • Saint-Petersburg, Russian Federation, 196084
        • Research Site
      • Saint-Petersburg, Russian Federation, 191180
        • Research Site
      • Saratov, Russian Federation, 410012
        • Research Site
      • Smolensk, Russian Federation, 214006
        • Research Site
      • St. Petersburg, Russian Federation, 197022
        • Research Site
      • Tomsk, Russian Federation, 634050
        • Research Site
      • Ulyanovsk, Russian Federation, 432009
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine, 58001
        • Research Site
      • Chernivtsi, Ukraine, 58000
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76012
        • Research Site
      • Kharkiv, Ukraine, 61002
        • Research Site
      • Kharkiv, Ukraine, 61058
        • Research Site
      • Kharkiv, Ukraine, 61035
        • Research Site
      • Kyiv, Ukraine, 04107
        • Research Site
      • Kyiv, Ukraine, 03680
        • Research Site
      • Lutsk, Ukraine, 43000
        • Research Site
      • Lviv, Ukraine, 79066
        • Research Site
      • Odesa, Ukraine, 65025
        • Research Site
      • Poltava, Ukraine, 36040
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Research Site
      • Vinnytsia, Ukraine, 21001
        • Research Site
      • Zaporizhzhia, Ukraine, 69096
        • Research Site
  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Research Site
    • California
      • Escondido, California, United States, 92025
        • Research Site
      • Sacramento, California, United States, 95821
        • Research Site
    • Florida
      • Hollywood, Florida, United States, 33021
        • Research Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Research Site
      • Rincon, Georgia, United States, 31326
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Research Site
    • New York
      • Bronx, New York, United States, 10455
        • Research Site
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Research Site
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Research Site
    • Texas
      • Sherman, Texas, United States, 75092
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research 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

36 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age 40-95 years at screening
  • Current or former smoker with a history of at least 10 pack-years of cigarette smoking
  • Current clinical diagnosis of COPD, with COPD symptoms > 1 year prior to screening, as defined by GOLD criteria or other current guidelines
  • COPD Severity defined by FEV1/FVC ratio <0.70 and FEV1 <80% of predicted normal value at screening and at randomisation
  • COPD treatment with rescue medication only, or stable dose of maintenance monotherapy (LAMA, LABA or ICS), or stable dose of double maintenance therapy (LAMA/LABA or ICS/LABA), for one month prior to screening
  • COPD Assessment Test (CAT) score ≥10 at randomisation
  • Documentation of a chest x-ray (as per local practice) or computed tomography (CT) within 6 months prior to screening, with no clinically significant pulmonary abnormalities other than related to COPD

Exclusion criteria:

  • Respiratory disease other than COPD, including:
  • Current diagnosis of asthma
  • Alpha-1 Antitrypsin Deficiency as the cause of COPD
  • Other respiratory disorders and conditions as listed in the protocol
  • Severe COPD exacerbation (resulting in hospitalisation) not resolved within 8 weeks prior to screening, or moderate exacerbation not resolved within 4 weeks, or during screening
  • Pneumonia or lower respiratory tract infection that required antibiotics within 8 weeks prior to screening, or during screening.
  • Significant diseases or conditions other than COPD which may put the patient at risk, or influence the results of the study or the patient's ability to participate, including cardiac disease, advanced renal disease, and cancer that has not been in complete remission for at least 5 years.
  • Patients who have needed additions or alterations to their usual maintenance therapy for COPD due to worsening symptoms within 1 month prior to and during screening
  • Treatment with depot corticosteroids within 6 weeks, or other systemic corticosteroids within 4 weeks, prior to screening. (Patients maintained on an equivalent of 5 mg prednisone per day for at least 3 months prior to screening are allowed.)

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: Double

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: Experimental
glycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily
Drug: Glycopyrronium/Formoterol Fumarate
Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
Active Comparator: Active comparator
umeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily
Drug: umeclidinium/vilanterol
Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation

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
Mean Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) Over 24 Weeks
Time Frame: From Baseline (Day 1) up to 24 weeks
To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.
From Baseline (Day 1) up to 24 weeks
Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in PP Analysis Set Population
Time Frame: From Baseline (Day 1) up to 24 weeks
To assess the effects of GFF relative to UV on lung function in PP analysis set population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
From Baseline (Day 1) up to 24 weeks
Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in FAS Population
Time Frame: From Baseline (Day 1) up to 24 weeks
To assess the effects of GFF relative to UV on lung function in FAS population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
From Baseline (Day 1) up to 24 weeks

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
Percentage of Participants With Increase of FEV1 of >=100 mL From Baseline at 5 Minutes Post-dosing on Day 1
Time Frame: 5 minutes post-dose on Day 1
The percentage of participants with an increase in FEV1 of >=100 mL from baseline at 5 minutes post-dosing on Day 1 was determined to assess the early onset of action. Baseline is defined as the average of available evaluable -60 and -30 minute pre-dose assessments conducted at randomization (Day 1). Only data assigned to the 5 minute window was used to determine response. Participants with missing data were considered non-responders for the analysis.
5 minutes post-dose on Day 1
Mean Peak Change From Baseline in Inspiratory Capacity (IC) Within 2 Hours Post-dosing Over 24 Weeks
Time Frame: From Baseline (Day 1) up to 24 weeks
Peak change from baseline in IC is defined as the maximum of the IC assessments within the 2 hours post-dosing time windows at each visit minus baseline. Baseline is defined as the average of available evaluable -60 and -30 minute pre-dose assessments conducted at randomization (Day 1).
From Baseline (Day 1) up to 24 weeks
Mean Transition Dyspnea Index (TDI) Focal Score Over 24 Weeks
Time Frame: From Baseline (Day -7 or 1) up to 24 weeks
The baseline dyspnea index (BDI) and TDI consist of 3 individual components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these 3 components were rated in 5 grades from 0 (very severe) to 4 (no impairment), and were summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea were rated for each component by 7 grades from -3 (major deterioration) to +3 (major improvement), and were added to form a TDI focal score from -9 to +9. Baseline is defined as the latest BDI assessment within 7 days before or at randomization (Day 1).
From Baseline (Day -7 or 1) up to 24 weeks
Mean Change From Baseline in Early Morning Symptoms of COPD Instrument (EMSCI) Over 24 Weeks
Time Frame: From Baseline (Day -7) up to 24 weeks
Change from baseline in the 6-item EMSCI Symptom Severity Score was derived by averaging the responses from a participant on the 6 item-level symptom scores (scored on a 4-point scale from 1 to 4, whereas 1= mild and 4= very severe). The EMSCI collected data about the frequency and severity of early morning symptoms and the impact of COPD symptoms on early morning activity in participants with COPD. Participants completed a daily electronic patient-reported outcome (ePRO) questionnaire for their COPD symptoms. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1). TI = Time interval.
From Baseline (Day -7) up to 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Night-Time Symptoms of COPD Instrument (NiSCI) Over 24 Weeks
Time Frame: From Baseline (Day -7) up to 24 weeks
Change from baseline in the 6-item NiSCI Symptom Severity Score was derived by averaging the responses from a participant on the 6 item-level symptom scores (scored on a 4-point scale from 1 to 4, whereas 1= mild and 4= very severe). The NiSCI collected data about the frequency and severity of night-time symptoms and the impact of COPD symptoms on night-time awakenings in participants with COPD. Participants completed a daily ePRO questionnaire for their COPD symptoms. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1).
From Baseline (Day -7) up to 24 weeks
Mean Change From Baseline in Daily Rescue (Albuterol/Salbutamol MDI) Use Over 24 Weeks
Time Frame: From Baseline (Day -7) up to 24 weeks
The number of inhalations of rescue albuterol/salbutamol MDI was recorded in the participant ePRO in the morning and evening. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1). a/s = albuterol/salbutamol.
From Baseline (Day -7) up to 24 weeks
Mean Change From Baseline in COPD Assessment Test (CAT) Score Over 24 Weeks
Time Frame: From Baseline (Day -7 or 1) up to 24 weeks
The CAT is used to quantify the impact of COPD symptoms on health status. The CAT has a scoring range of 0-40, and it is calculated as the sum of the responses given for each of the 8 items (scored on a 6-point scale from 0 to 5), with higher scores indicating a higher impact of COPD symptoms on health status. If the response to 1 of the 8 items is missing, the missing item was considered equal to the average of the 7 non-missing items for that participant. If more than 1 item is missing the score was considered missing. Baseline is defined as the latest assessment within 7 days before or at randomization (Day 1).
From Baseline (Day -7 or 1) up to 24 weeks

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.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel International Ltd
Cognizant Technology Solution
Center for Information & Study on Clinical Research Participation (CISCRP)
eResearchTechnology
QuintilesIMS Limited
Corporate Translations 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

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 (Actual)

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 25, 2017

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.
May 4, 2018

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.
May 4, 2018

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 19, 2017

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 19, 2017

First Posted (Actual)

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 22, 2017

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.
May 22, 2019

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.
April 30, 2019

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.
April 1, 2019

More Information

Terms related to this study

Keywords

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.
  • D5970C00002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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