An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device

Asthma Clinical Trial

— NEXThalerPIF  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651650
• Other study ID #: CCD-1113-PR-0074
• Secondary ID: 2012-000039-22
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2012
• Last updated: April 12, 2018
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler® device in adult asthmatic patients with varying degrees of disease control.

Description:

The primary objective of this study is to assess the inspiratory flow profile through the NEXThaler® device in adult asthmatics with varying degrees of disease control.

The study plan foresees one visit at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be instructed to use the NEXThaler®. The patients will subsequently inhale through the device and the inspiration profile will be measured.

A total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with partly controlled or uncontrolled disease according to GINA guidelines (2011), will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of controlled, partly controlled or uncontrolled asthma according to GINA guidelines (2011)

• 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:

• Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer

• History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit)

• Diagnosis of restrictive lung disease

• Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Inhalation through Chiesi NEXThaler DPI
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set

Locations

Country	Name	City	State
Italy	Clinica Pneumologica, AOU di Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of inhalatory profile for 40 patients	The study duration per patient is only one visit. At visit 1 the patient after having signed off the ICF and after having assessed the Eligibility Criteria should perform two evaluable inhalatory manoeuvres. 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.	One visit per patient (visit 1)

External Links

•   Study Record on EU Clinical Trials Register including results