Adults asthmatics Patients with varying degrees of disease control. MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 1535 NEXThaler placebo
Product Code: NA
Pharmaceutical Form: Inhalation powder
Other descriptive name: CHF 1535 NEXThaler placebo
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
CHIESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from the patient and/or the legal representatives 2. Inpatients and outpatients of both sexes, aged = 18 years 3. Clinical diagnosis of controlled, partly controlled or uncontrolled asthma according to GINA guidelines (2011) 4. 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable) 2. Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer 3. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) 4. Diagnosis of restrictive lung disease Clinical Study Protocol No.: CCD-1113-PR-0074 Version No.: 1.0 EUDRACT No.: 2012-000039-22 Date: 30th March 2012 CONFIDENTIAL Page 7/30 5. Allergy to any component of the placebo treatment 6. Inability to comply with study procedures or treatment 7. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Outcome results
None listed