Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients

Asthma Clinical Trial

Official title:

In-vivo Deposition Measurement of Beclometasone and Formoterol After Inhalation of a Single Dose of the Combination BDP Plus Formoterol NEXT DPI in Healthy Volunteers, Asthmatic and COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176747
• Other study ID #: CCD-0815-PR-0011
• Secondary ID: 2009-010267-17
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Healthy volunteers:

• 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:

All subjects:

• 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;

Additional exclusion criteria for healthy volunteers:

• Lung function measurements outside normal limits (normal values: FEV1/FVC > 0.70 and FEV1 and FVC > 80% for the ECSC predicted values);

Additional exclusion criteria for patients with Asthma:

• 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.

Additional exclusion criteria for patients with COPD:

• 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.

Related Conditions & MeSH terms

• Asthma
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Germany	Inamed Research GmbH & Co. KG	Gauting

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Häussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(®) Device in Healthy Subjects, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler	Calculated using the individual Gamma camera images and the regions of interest defined from the 81mKrypton-ventilation scan.	Immediately after dosing
Secondary	Distribution of lung deposition		Immediately after dosing
Secondary	Extrathoracic deposition		Immediately after dosing
Secondary	Exhaled activity		Immediately after dosing
Secondary	Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP)		over 24 h post dose
Secondary	Lung function parameters		over 24 h post dose

External Links

•   CSR Synopsis available in the CHIESI Clinical Study Register
•   Study Record on EU Clinical Trials Register including results