Clinical trial NCT02018549: An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI
Official title: An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler Dry Powder Inhaler (DPI) Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD
placebo
inhalatory profile
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

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.

Primary outcomes:
measure: Evaluation of Inhalatory Profile for 80 patients
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Ospedale di Parma
Study officials:
affiliation: Chiesi Farmaceutici S.p.A.
name: Mario Scuri, MD
role: STUDY_DIRECTOR
References: