Back to resultsAn Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device (NEXThalerPIF)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Inhalation through Chiesi NEXThaler DPI
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, PIF
Eligibility Criteria
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.
Sites / Locations
- Clinica Pneumologica, AOU di Parma
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Inhalation of Placebo Dry Powder
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01651650
First Posted
July 5, 2012
Last Updated
April 12, 2018
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01651650
Brief Title
An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device
Acronym
NEXThalerPIF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, PIF
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inhalation of Placebo Dry Powder
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inhalation through Chiesi NEXThaler DPI
Intervention Description
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
Primary Outcome Measure Information:
Title
Evaluation of inhalatory profile for 40 patients
Description
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.
Time Frame
One visit per patient (visit 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo A. Chetta, MD
Organizational Affiliation
Clinica Pneumologica, AOU di Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Pneumologica, AOU di Parma
City
Parma
ZIP/Postal Code
43124
Country
Italy
12. IPD Sharing Statement
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000039-22
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device
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