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

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01176747
First received: August 5, 2010
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
Drug: BDP/formoterol NEXT DPI
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]
    Calculated using the individual Gamma camera images and the regions of interest defined from the 81mKrypton-ventilation scan.


Secondary Outcome Measures:
  • Distribution of lung deposition [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]
  • Extrathoracic deposition [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]
  • Exhaled activity [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP) [ Time Frame: over 24 h post dose ] [ Designated as safety issue: No ]
  • Lung function parameters [ Time Frame: over 24 h post dose ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BDP/formoterol NEXT DPI
Radiolabelled BDP/formoterol 100/6 µg dry powder administered via the NEXT inhaler
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)
Other Name: CHF 1535 NEXT DPI

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176747

Locations
Germany
Inamed Research GmbH & Co. KG
Gauting, Germany, 82131
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Thomas Meyer, MD Inamed Research GmbH & Co. KG
  More Information

No publications provided

Responsible Party: Marisa Minetti, website administrator, Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01176747     History of Changes
Other Study ID Numbers: CCD-0815-PR-0011, 2009-010267-17
Study First Received: August 5, 2010
Last Updated: April 13, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014