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

NCT01176747 | Completed Phase 1

• 2 other identifiers: CCD-0815-PR-00112009-010267-17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Distribution of lung deposition

  Immediately after dosing

• Extrathoracic deposition

  Immediately after dosing

• Exhaled activity

  Immediately after dosing

• Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP)

  over 24 h post dose

• Lung function parameters

  over 24 h post dose

Study Arms (1)

BDP/formoterol NEXT DPI

EXPERIMENTAL

Radiolabelled BDP/formoterol 100/6 µg dry powder administered via the NEXT inhaler

Drug: BDP/formoterol NEXT DPI

Interventions

BDP/formoterol NEXT DPI DRUG

Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)

Also known as: CHF 1535 NEXT DPI

BDP/formoterol NEXT DPI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Inamed Research GmbH & Co. KG

Gauting, 82131, Germany

Location

Related Publications (1)

• 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.

  PMID: 29989511 RESULT

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Meyer, MD

  Inamed Research GmbH & Co. KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

DE (1)