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Chronic Obstructive Pulmonary Disease (COPD)Phase 2GlycoNEXTNCT02680197

Study to Evaluate Efficacy/Safety of 4 Doses of CHF5259 Via Dry Powder Inhaler (DPI) in Patients With COPD

A Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 30 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 study was designed to investigate the efficacy and safety of different doses CHF5259 a long acting muscarinic antagonist in patients with moderate to severe COPD. Read more about this study

Who is it for?
Ages 40 years and older
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
262 participants
Where
30 sitesin 4 countries
Study dates
29 Feb 2016to 6 Feb 2017
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Male or female patients aged ≥ 40 years
  • Patients with a diagnosis of stable COPD at least 12 months before screening visit.
  • Current smoker or ex-smoker with a smoking history of at least 10 pack-years
  • - A post-bronchodilator FEV1 ≥ 40% and ≤70% of the predicted normal value and,
  • a post-bronchodilator FEV1/FVC < 0.7 and,
  • a change in FEV1 from the pre-bronchodilator value (reversibility) of at least 5% at screening
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  • Patients under bronchodilators with long-acting muscarinic antagonist or long-acting 2 agonist (monotherapy or dual therapy), or patients under ICS + LABA (long-acting beta2-agonist) or ICS (Inhaled Corticosteroids) + LAMA (Long Acting Muscarinic Agonist) for at least 4 weeks prior to screening.
  • (Patients with a FEV1<50% of the predicted value and a history of 1 exacerbation within the last 12 months must have been treated with ICS+LABA or ICS+LAMA before screening)
  • Ability and cooperative attitude to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres) and ability to understand the risks involved. Ability to be trained to use the dry powder inhalers.

Who cannot join

  • Diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion.
  • Patients had a COPD exacerbation or a lower respiratory tract infection within 8 weeks prior to screening, or during the run-in period, that resulted in the use of an antibiotic, or oral or parenteral corticosteroids, or hospitalisation.
  • Patients with a history of ≥ 2 exacerbations within the last 12 months prior to screening.
  • Patients treated with oral/parenteral β2-agonists or nebulised bronchodilators or phosphodiesterase inhibitors or who received LABA/LAMA/ICS treatment therapy in the 4 weeks prior to screening and during the run-in period.
  • Patient is on an inhaled corticosteroid that has been initiated, or the effective dose has been changed, within 4 weeks prior to screening or during the run-in period (patients on stable dose of ICS for at least 4 weeks prior to screening are allowed).
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
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  • Patients with known respiratory disorders other than COPD including but not limited to alpha1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
  • Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
  • Patients who have unstable concurrent disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study;
  • Patients who have a concomitant disease of poor prognosis (e.g., cancer...).
  • Patients who have clinically significant cardiovascular condition diagnosed in the last 6 months
  • Patients with known atrial fibrillation (AF):
  • Paroxysmal Atrial Fibrillation
  • Persistent
  • Long standing persistent.
  • Permanent
  • Patients with a clinically significant abnormal 12-lead ECG that might, in the judgment of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
  • Patients whose electrocardiogram 12-lead ECG shows a QTcF>450 ms for males or QTcF > 470 ms for females.
  • Patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
  • Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control methods
  • Patients known to have intolerance/hypersensitivity or any contra-indication to treatment with M3 Antagonist or any of the excipients contained in the formulations used in the study.
  • Patients who have evidence of alcohol or drug abuse, not compliant with the study protocol or not compliant with the study treatments according to investigator's judgment.
  • Patients with major surgery in the previous 3 months or planned during the trial which may affect patient's compliance in study procedures.
  • Patients who have participated in another clinical trial with an investigational drug in the 2 months preceding the screening.

Trial locations and contacts

30 sites in 4 countries.

30 sites in 4 countries

Hungary9 sites

  • Clinical Trail Site 348-006

    Budapest, 1113

  • Clinical Trial Site 348-003

    Budapest, 1126

  • Clinical Trial Site 348-004

    Budapest, 1126

  • Clinical Trial Site 348-001

    Deszk, 6772

  • Clinical Trial Site 348-005

    Komárom, 2900

  • Clinical Trial Site 348-002

    Létavértes, 4283

  • Clinical Trail Site 348-008

    Miskolc, 3519

  • Clinical Trail Site 348-009

    Seregélyes, 8111

  • Clinical Trail Site 348-007

    Szombathely, 3700

Other trials in Hungary

Romania8 sites

  • Clinical Trial Site 642-005

    Bacau, 600252

  • Clinical Trial Site 642-003

    Brasov, 500283

  • Clinical Trial Site 642-007

    Bucharest, 030303

  • Clinical Trial Site 642-008

    Bucharest, 030303

  • Clinical Trial Site 642-004

    Cluj-Napoca, 400445

  • Clinical Trial Site 642-001

    Codlea, 505100

  • Clinical Trial Site 642-002

    Miercurea-Ciuc

  • Clinical Trial Site 642-006

    Suceava, 720224

Other trials in Romania

Czechia7 sites

  • Clinical Trial Site 203-002

    Karlovy Vary, 36017

  • Clinical Trial Site 203-003

    Kralupy nad Vltavou, 27801

  • Clinical Trial Site 203-001

    Mělník, 25063

  • Clinical Trial Site 203-007

    Mladá Boleslav, 29350

  • Clinical Trial Site 203-005

    Moravský Krumlov, 67201

  • Clinical Trial Site 203-006

    Teplice, 41501

  • Clinical Trial Site 203-004

    Varnsdorf, 40447

Other trials in Czechia

Germany6 sites

  • Clinical Trial Site 276-003

    Bonn, 53111

  • Clinical Trial Site 276-004

    Cottbus, 03053

  • Clinical Trial Site 276-006

    Freiburg im Breisgau, 579106

  • Clinical Trial Site 276-002

    Großhansdorf, 22927

  • Clinical Trial Site 276-005

    Stuttgart, 70174

  • Clinical Trial Site 276-001

    Wiesbaden, 65187

Other trials in Germany

About this study

Official title: Randomised, Double Blind, Placebo-controlled, Incomplete Block, 3-way Cross-over Study to Evaluate Efficacy and Safety of 4 Doses of Glycopyrronium Bromide (CHF5259) DPI in Moderate to Severe Patients With COPD

The study was designed to investigate the efficacy and safety of different doses CHF5259 a long acting muscarinic antagonist in patients with moderate to severe COPD.

Read the detailed description

Outpatients attending the hospital clinics/study centres will be recruited. Patients with moderate to severe COPD airflow obstruction according to GOLD 2015 criteria.

A total of approximately 300 patients will be enrolled.

Patients are followed during 3 different treatment periods of 4 weeks separated each by 3 weeks wash-out period. The study lasts approximately 21 weeks for each patient and a total of 11 clinic visits is performed during the study.

The primary endpoint is the Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-12h normalised by time on Day 28.

Being tested
CHF5259 or Placebo administration
Keywords
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.

  • CHF5259 or Placebo administrationDrug

    Administration of 2 puffs of treatment in the morning and in the evening during a 4 week period. Each patient will be allocated to 3 out of the 5 possible treatments.

Study groups in NCT02680197
Study groupRoleWhat they receive
CHF5259 12.5 μg total daily doseExperimentalCHF5259 or Placebo administration: Patient receives during 4 weeks (28 days) the following treatment : 1 puff of CHF5259 DPI 6.25μg + 1 puff of CHF5259 DPI matched placebo twice a day Day 1 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram Day 14: pre-dose spirometry Day 28 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram
Receives: Drug: CHF5259 or Placebo administration
CHF5259 25 μg total daily doseExperimentalCHF5259 or Placebo administration: Patient receives during 4 weeks (28 days) the following treatment : 1 puff of CHF5259 DPI 6.25μg + 1 puff of CHF5259 DPI 6.25μg twice a day Day 1 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram Day 14: pre-dose spirometry Day 28 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram
Receives: Drug: CHF5259 or Placebo administration
CHF5259 50 μg total daily doseExperimentalCHF5259 or Placebo administration: Patient receives during 4 weeks (28 days) the following treatment : 1 puff of CHF5259 DPI 12.5 μg + 1 puff of CHF5259 DPI 12.5 μg twice a day Day 1 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram Day 14: pre-dose spirometry Day 28 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram
Receives: Drug: CHF5259 or Placebo administration
CHF5259 100μg total daily doseExperimentalCHF5259 or Placebo administration: Patient receives during 4 weeks (28 days) the following treatment :1 puff of CHF5259 DPI 25 μg + 1 puff of CHF5259 DPI 25 μg twice a day Interventions : Day 1 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram Day 14: pre-dose spirometry Day 28 : pre-dose spirometry, serial spirometry, Haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram
Receives: Drug: CHF5259 or Placebo administration
CHF5259 matched Placebo BIDPlacebo comparatorCHF5259 or Placebo administration: Patient receives during 4 weeks (28 days) the following treatment : 2 puffs of CHF5259 DPI matched placebo twice a day Interventions : Day 1 : pre-dose spirometry, serial spirometry, haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram Day 14: pre-dose spirometry Day 28 : pre-dose spirometry, serial spirometry, haematology/chemistry sample and analyses, BDI/TDI (Baseline and transition dyspnea Indexes), Electrocardiogram
Receives: Drug: CHF5259 or Placebo administration

What is being measured

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

  1. FEV1 AUC0-12h normalised by time (L)

    Measured: Day 28

Secondary outcomes (8)

  1. Change from baseline in morning pre-dose FEV1 (L)

    Measured: Day 28

  2. Change from baseline in morning pre-dose FEV1 (L)

    Measured: Day 14

  3. Peak0-4h effect in FEV1 (L)

    Measured: Day 28

  4. Adverse events and adverse drug reactions

    Measured: Day 28

  5. Change from baseline in morning pre-dose Forced Vital Capacity FVC (L)

    Measured: Day 28

  6. Change from baseline in morning pre-dose FVC (L)

    Measured: Day 14

  7. Change from baseline in morning pre-dose Inspiratory Capacity IC (L)

    Measured: Day 28

  8. Change from baseline in morning pre-dose IC (L)

    Measured: Day 14

Timeline

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

  1. First posted11 Feb 2016 (estimated)
  2. Study start29 Feb 2016
  3. Primary completion6 Feb 2017
  4. Study completion6 Feb 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02680197
Sponsor's protocol ID
CCD-06302AA1-01
Other IDs
2015-000558-40, 2015
Acronym
GlycoNEXT
Status last verified
Jul 2020
First submitted
4 Feb 2016
Last updated
31 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Beeh KM, Emirova A, Prunier H, Santoro D, Nandeuil MA. Dose-response of an extrafine dry powder inhaler formulation of glycopyrronium bromide: randomized, double-blind, placebo-controlled, dose-ranging study (GlycoNEXT). Int J Chron Obstruct Pulmon Dis. 2018 May 25;13:1701-1711. doi: 10.2147/COPD.S168493. eCollection 2018.

    PubMed 29872288

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 30 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 9 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Hungary, Romania, Czechia, Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

FEV1 AUC0-12h normalised by time (L) (time frame: Day 28). 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 NCT02680197, 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 31 Jul 2020.

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