COPD
Conditions
Keywords
COPD, placebo, inhalatory profile
Brief summary
Phase IIa, single center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation
Detailed description
As this is an exploratory study, a total of 70 to 80 completed patients, ensuring the following distribution in terms of COPD Stage as per GOLD 2013 (updated) spirometric classification of disease severity, are deemed to be sufficient for assessing the inhalation profile through the NEXThaler®: * 10 to 20 COPD GOLD Stage I patients * 20 patients in each of the COPD GOLD Stage II to IV. Assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients. All the analyses will be performed separately for the first and the second inhalation. Results stratified by disease severity and overall will be presented.
Interventions
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
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 | Description |
|---|---|---|
| Evaluation of Inhalatory Profile for 80 patients | Visit 1 | The study duration per patient is only one visit. At visit 1 the patient after having signed the ICF and after having assessed the eligibility criteria should perform two evaluable inhalatory manoeuvres through the device instrumented with an acoustic monitoring system (microphone). The sounds captured by the microphone are sent to a PC which acquire it for analysis of the profile. Each manoeuvre lasts few seconds. After having completed the manoeuvres and have the same assessed as good by the Investigator, the study is completed. All the procedures are expected to be performed within a couple of hours for each patient. |
Countries
Italy
Outcome results
None listed