An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device
Study Identifier:
CCD-1113-PR-0074
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Asthma
Study Drug
Date
Jun 2012 - Sep 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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.
Healthy Volunteers
No
Protocol 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.
Study Locations
Location
Status
Location
Clinica Pneumologica, AOU di Parma
Parma, Italy, 43124
Status
N/A