Chronic Obstructive Pulmonary Disease MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Nacystelyn 20 mg
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: L-Lysine-N-acetyl-cysteinate
CAS Number: 89344-48-9
Current Sponsor code: NAL
Other descriptive
Sponsors
LABORATOIRES SMB S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient is able to give signed written informed consent prior to study entry. 2.Male or female patients 40 – 85 years, inclusive, as of the screening visit. 3.Patient is an ex-smoker with a minimum 10 pack-years of historical use (the equivalent of one pack per day for 10 years). 4.Patient has a diagnosis of COPD according to the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria with a postbronchodilator FEV1 of 25 - 60% of predicted and a FEV1/FVC=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: 1.Known respiratory disorder other than COPD, including but not limited to the following: alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary oedema, or interstitial lung disease, known active tuberculosis. 2.Evidence or history of other clinically significant disease or abnormality that in the opinion of the Investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. 3.Hospitalization for a COPD exacerbation or pneumonia within 6 weeks prior to the screening visit. 4.Treatment for a non-hospitalized COPD exacerbation or pneumonia requiring antibiotics and/or systemic corticosteroids within 4 weeks prior to the screening visit. 5.The patient is pregnant or lactating, or plans to become pregnant or donate gametes (ova or sperm) during the study period or for 30 days after the patient’s last study-related visit (for eligible patients only, if applicable). Eligible female and male patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study. 6.Treatment with oral, intravenous, or intramuscular corticosteroids within 4 weeks prior to the screening visit. 7.Inability to discontinue prohibited medications during the screening, run-in and treatment periods. 8.Documented or suspected viral or bacterial, upper respiratory infection (URI) or lower respiratory infection (LRI), sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 4 weeks prior to the screening visit. 9.Patient did experience an AE that, in the opinion of the Investigator, would result in failure to meet the inclusion/exclusion criteria during the screening period. 10.History of allergy or hypersensitivity to acetylcysteine, anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, mannitol, or known hypersensitivity to any of the proposed ingredients or components of the delivery system. 11.Factors (e.g. infirmity, disability, or geographic location) that the Investigator feels would likely limit the patient's compliance with the study protocol or study visits. 12.Current evidence or known history of alcohol or substance abuse within 2 years of the screening visit. 13.Patient is either an employee of the investigational center or an immediate relative of an employee of the investigational center. 14.History of lung volume reduction surgery within the previous 12 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effect of chronic dosing of different doses of NAL on changes in airway geometry with Functional Respiratory Imaging (FRI).;Secondary Objective: The secondary objective of this study is to assess the effect of chronic dosing of different doses of NAL on changes in lung function parameters and patient reported outcomes.;Primary end point(s): The following primary FRI endpoints will be evaluated: Structure: •specific airway volume (siVaw) at FRC (V1 and V4) & TLC Function: •specific airway resistance (siRaw) at FRC (V1 and V4) and TLC ;Timepoint(s) of evaluation of this end point: Visits 1 & 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary FRI endpoints are: Exposure: •aerosol deposition Structure: •lung and lobar volume at FRC (V1 and V4) & TLC •airway wall volume Function: •internal airflow distribution The secondary spirometry endpoints are: •Forced expiratory volume in 1 second (FEV1) •Functional residual capacity (FRC) •Forced vital capacity (FVC) •Tiffeneau-Pinelli index (FEV1/FVC ratio) Additional secondary endpoints are : •Vital Capacity (VC) and Total Lung Capacity (TLC), based on body plethysmography •Airway resistances: Airway resistance (Raw) and Specific airway conductance (SGaw), based on body plethysmography •Patient reported outcomes: CRQ-SR ;Timepoint(s) of evaluation of this end point: Visits 1 to 4 | — |
Countries
Belgium
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A
Outcome results
None listed