COPD MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: CHF 1535 NEXThaler® Placebo
Pharmaceutical Form: Inhalation powder
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the patient and/or the legal representatives 2. Inpatients and outpatients of both sexes, aged = 40 years 3. Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible 4. A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable) 2. Diagnosis of asthma 3. Diagnosis of restrictive lung disease 4. Allergy to any component of the placebo treatment 5. Inability to comply with study procedures or treatment 6. Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the inspiration profile through the NEXThaler® device in COPD patients with varying degrees of airflow limitation as per GOLD 2013 (updated) spirometric classification of disease severity.;Secondary Objective: The secondary objective of the study is to evaluate the potential correlation between the lung function parameters measured by spirometry at clinic and the variables measured by acoustic monitoring technology during the inspiratory manoeuvre.;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactProject Management unit
CROMSOURCE
Outcome results
None listed