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

NCT01651650 | Completed Phase 2

• 2 other identifiers: CCD-1113-PR-00742012-000039-22
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; PIF

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Inhalation of Placebo Dry Powder

OTHER

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

Interventions

Inhalation through Chiesi NEXThaler DPI DEVICE

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

Inhalation of Placebo Dry Powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Clinica Pneumologica, AOU di Parma

Parma, 43124, Italy

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alfredo A. Chetta, MD

  Clinica Pneumologica, AOU di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 27, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 13, 2018

Record last verified: 2017-03

Locations

IT (1)