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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01651650
First received: July 5, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Device: Inhalation through Chiesi NEXThaler DPI
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Evaluation of inhalatory profile for 40 patients [ Time Frame: One visit per patient (visit 1) ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Inhalation of 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651650

Locations
Italy
Clinica Pneumologica, AOU di Parma
Parma, Italy, 43124
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Alfredo A. Chetta, MD Clinica Pneumologica, AOU di Parma
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01651650     History of Changes
Other Study ID Numbers: CCD-1113-PR-0074
Study First Received: July 5, 2012
Last Updated: January 29, 2013
Health Authority: Italy: AIFA (Agenzia Italiana del Farmaco)

Keywords provided by Chiesi Farmaceutici S.p.A.:
Asthma
PIF

ClinicalTrials.gov processed this record on October 01, 2014