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

NCT ID: NCT01651650

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-09-30

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Inhalation through Chiesi NEXThaler DPI

Intervention Type: DEVICE

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

Interventions

Inhalation through Chiesi NEXThaler DPI

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo A. Chetta, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Pneumologica, AOU di Parma

Locations

Clinica Pneumologica, AOU di Parma

Parma, , Italy

Countries

Italy

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000039-22

Study Record on EU Clinical Trials Register including results

Other Identifiers

2012-000039-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCD-1113-PR-0074

Identifier Type: -

Identifier Source: org_study_id