An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI

Study Identifier:
CCD_01535BC1_01
ClinicalTrials.gov Identifier:
NCT02018549
EudraCT Identifier:
2013-000262-11
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
Download document(s)

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
    Date
    Dec 2013 - Jun 2014
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 40+ years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Written informed consent obtained from the patient and/or the legal representatives
    • Inpatients and outpatients of both sexes, aged ≥ 40 years
    • Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
    • 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
    • Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
    • Diagnosis of asthma
    • Diagnosis of restrictive lung disease
    • Allergy to any component of the placebo treatment
    • Inability to comply with study procedures or treatment
    • Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented 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 center, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler device in adult COPD patients with varying degrees of airflow limitation

    Study Locations

    Location
    Status
    Location
    Ospedale di Parma
    Parma, Italy, 43125
    Status
    N/A