An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI (PIF3)

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

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

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Inhalation through Chiesi NEXThaler DPI

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43125
    • Ospedale di Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo; Inhalation through Chiesi NEXThaler DPI containing Placebo Dry Powder. Each patient will perform at least two inhalations using the Chiesi NEXThaler DPI device containing placebo dry powder. There is no comparator and all patients will receive the same study treatment.	Device: Inhalation through Chiesi NEXThaler DPI; Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Inhalatory Profile for 80 patients	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.	Visit 1

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Study Director: Mario Scuri, MD, Chiesi Farmaceutici S.p.A.

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results
• CSR Synopsis available in the CHIESI Clinical Study Register

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: COPD; placebo; inhalatory profile
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: CCD_01535BC1_01; 2013-000262-11 (EudraCT Number)