Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients
NCT ID: NCT01176747
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
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2010-08-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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BDP/formoterol NEXT DPI
Radiolabelled BDP/formoterol 100/6 µg dry powder administered via the NEXT inhaler
BDP/formoterol NEXT DPI
Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
Interventions
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BDP/formoterol NEXT DPI
Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and females aged 18-65 years;
* Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
* Non- or ex-smokers who smoked \< 5 pack years and stopped smoking \> 1 year;
* Normal blood pressure and heart rate;
* Normal electrocardiogram (ECG,12 lead);
* Normal laboratory tests;
Patients with Asthma:
* Males and females aged 21-65 years;
* BMI between 18.0 and 28.0 kg/m2;
* Non- or ex-smokers who smoked \< 5 pack years and stopped smoking \> 1 year;
* Normal blood pressure and heart rate;
* Normal ECG (12 lead);
* FEV1 ≥ 30% and \< 80% of predicted according to European Coal and Steel Community values (ECSC)
* Reversibility of FEV1 ≥ 12% and at least 200 ml of the initial value 15 minutes after inhalation of 200 µg Salbutamol;
Patients with COPD:
* Males and females aged 40 - 70 years
* BMI between 18.0 and 30.0 kg/m2;
* Normal blood pressure and heart rate;
* Normal ECG (12 lead);
* Stable COPD within the past 4 weeks;
* Post bronchodilator FEV1 between 30% and 50% predicted values (ECSC);
* Post bronchodilator FEV1/FVC \< 0.70 (absolute value);
* Minimum smoking history of 10 pack-years;
Exclusion Criteria
* Blood donation or blood loss in the previous 8 weeks;
* Positive HIV1 or HIV2 serology;
* Positive acute or chronic Hepatitis B or Hepatitis C;
* Unsuitable veins for repeated venipuncture;
* Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception.
* History of substance abuse or positive urine drug screen;
* Abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
* Uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric clinically significant disorder;
* Participation in another clinical trial in the previous 8 weeks; participation in study using radioactive material within 1 calendar year;
* Known sensitivity to Formoterol or Beclometasone or any of the excipients;
* Concomitant severe diseases or diseases which are contra indications for the use of inhaled Beta-2-agonist or steroids;
* Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated;
* Recent relevant infectious disease (less than two months);
* Flu vaccination or other vaccination within 4 weeks prior to the screening visit;
* Lung function measurements outside normal limits (normal values: FEV1/FVC \> 0.70 and FEV1 and FVC \> 80% for the ECSC predicted values);
* Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
* Life-threatening/unstable respiratory status within the previous 30 days;
* Requirement of supplemental oxygen therapy;
* Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit;
* Asthma exacerbation within the 4 weeks prior to inclusion.
* Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months;
* Life-threatening/unstable respiratory status within the previous 30 days;
* Requirement of supplemental oxygen therapy;
* Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit;
* COPD exacerbation within the 4 weeks prior to inclusion;
* History of asthma or any chronic respiratory diseases other than COPD.
18 Years
70 Years
ALL
Yes
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Chiesi Farmaceutici S.p.A.
Principal Investigators
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Thomas Meyer, MD
Role: PRINCIPAL_INVESTIGATOR
Inamed Research GmbH & Co. KG
Locations
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Inamed Research GmbH & Co. KG
Gauting, , Germany
Countries
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References
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Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.
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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2009-010267-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-0815-PR-0011
Identifier Type: -
Identifier Source: org_study_id