An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler DPI
NCT ID: NCT02018549
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2013-12-31
2014-06-30
Brief Summary
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Detailed Description
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* 10 to 20 COPD GOLD Stage I patients
* 20 patients in each of the COPD GOLD Stage II to IV. Assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients.
All the analyses will be performed separately for the first and the second inhalation. Results stratified by disease severity and overall will be presented.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Placebo
Inhalation through Chiesi NEXThaler DPI containing 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.
Inhalation through Chiesi NEXThaler DPI
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
Interventions
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Inhalation through Chiesi NEXThaler DPI
Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
Eligibility Criteria
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Inclusion Criteria
2. Inpatients and outpatients of both sexes, aged ≥ 40 years
3. 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
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
Exclusion Criteria
2. Diagnosis of asthma
3. Diagnosis of restrictive lung disease
4. Allergy to any component of the placebo treatment
5. Inability to comply with study procedures or treatment
6. 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.
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Mario Scuri, MD
Role: STUDY_DIRECTOR
Chiesi Farmaceutici S.p.A.
Locations
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Ospedale di Parma
Parma, , Italy
Countries
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Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2013-000262-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD_01535BC1_01
Identifier Type: -
Identifier Source: org_study_id