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

NCT02680197 | Completed Phase 2

• 2 other identifiers: CCD-06302AA1-012015-000558-40
• Study Type: interventional
• Target: 262
• Locations: 4 countries
• Sites: 30

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC0-12h normalised by time (L)

  Day 28

Secondary Outcomes (8)

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

  Day 28

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

  Day 14

• Peak0-4h effect in FEV1 (L)

  Day 28

• Adverse events and adverse drug reactions

  Day 28

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

  Day 28

Study Arms (5)

CHF5259 12.5 μg total daily dose

EXPERIMENTAL

CHF5259 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

Drug: CHF5259 or Placebo administration

CHF5259 25 μg total daily dose

EXPERIMENTAL

CHF5259 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

Drug: CHF5259 or Placebo administration

CHF5259 50 μg total daily dose

EXPERIMENTAL

CHF5259 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

Drug: CHF5259 or Placebo administration

CHF5259 100μg total daily dose

EXPERIMENTAL

CHF5259 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

Drug: CHF5259 or Placebo administration

CHF5259 matched Placebo BID

PLACEBO COMPARATOR

CHF5259 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

Drug: CHF5259 or Placebo administration

Interventions

CHF5259 or Placebo administration DRUG

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.

CHF5259 100μg total daily dose; CHF5259 12.5 μg total daily dose; CHF5259 25 μg total daily dose; CHF5259 50 μg total daily dose; CHF5259 matched Placebo BID

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (30)

Clinical Trial Site 203-002

Karlovy Vary, 36017, Czechia

Location

Clinical Trial Site 203-003

Kralupy nad Vltavou, 27801, Czechia

Location

Clinical Trial Site 203-001

Mělník, 25063, Czechia

Location

Clinical Trial Site 203-007

Mladá Boleslav, 29350, Czechia

Location

Clinical Trial Site 203-005

Moravský Krumlov, 67201, Czechia

Location

Clinical Trial Site 203-006

Teplice, 41501, Czechia

Location

Clinical Trial Site 203-004

Varnsdorf, 40447, Czechia

Location

Clinical Trial Site 276-003

Bonn, 53111, Germany

Location

Clinical Trial Site 276-004

Cottbus, 03053, Germany

Location

Clinical Trial Site 276-006

Freiburg im Breisgau, 579106, Germany

Location

Clinical Trial Site 276-002

Großhansdorf, 22927, Germany

Location

Clinical Trial Site 276-005

Stuttgart, 70174, Germany

Location

Clinical Trial Site 276-001

Wiesbaden, 65187, Germany

Location

Clinical Trail Site 348-006

Budapest, 1113, Hungary

Location

Clinical Trial Site 348-003

Budapest, 1126, Hungary

Location

Clinical Trial Site 348-004

Budapest, 1126, Hungary

Location

Clinical Trial Site 348-001

Deszk, 6772, Hungary

Location

Clinical Trial Site 348-005

Komárom, 2900, Hungary

Location

Clinical Trial Site 348-002

Létavértes, 4283, Hungary

Location

Clinical Trail Site 348-008

Miskolc, 3519, Hungary

Location

Clinical Trail Site 348-009

Seregélyes, 8111, Hungary

Location

Clinical Trail Site 348-007

Szombathely, 3700, Hungary

Location

Clinical Trial Site 642-005

Bacau, 600252, Romania

Location

Clinical Trial Site 642-003

Brasov, 500283, Romania

Location

Clinical Trial Site 642-007

Bucharest, 030303, Romania

Location

Clinical Trial Site 642-008

Bucharest, 030303, Romania

Location

Clinical Trial Site 642-004

Cluj-Napoca, 400445, Romania

Location

Clinical Trial Site 642-001

Codlea, 505100, Romania

Location

Clinical Trial Site 642-002

Miercurea-Ciuc, Romania

Location

Clinical Trial Site 642-006

Suceava, 720224, Romania

Location

Related Publications (1)

• 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.

  PMID: 29872288 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai-Michael BEEH, MD

  Institut fuer Atemwegsforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 11, 2016
• Study Start: February 29, 2016
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (7); HU (9); DE (6); RO (8)