Foster With or Without Charcoal Block or Aerochamber Plus

NCT01280175 | Completed Phase 1

• 1 other identifier: FB/PS/14/163/06
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator

Conditions

Healthy Volunteers

Keywords

BDP; Formoterol; pMDI; Aerochamber Plus; Charcoal

Outcome Measures

Primary Outcomes (1)

• Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.

  from pre-dose until 12 h post-dose

Secondary Outcomes (1)

• General tolerability and safety of the test product.

  from pre-dose until 12 h post-dose

Study Arms (3)

pMDI + charcoal block

EXPERIMENTAL

BDP/formoterol 100/6 µg pMDI with charcoal ingestion

Procedure: charcoal block

pMDI + Aerochamber Plus

EXPERIMENTAL

BDP/formoterol 100/6 µg with Aerochamber Plus

Device: Aerochamber Plus spacer

pMDI

ACTIVE COMPARATOR

BDP/formoterol 100/g µg pMDI

Drug: pMDI standard actuator

Interventions

charcoal block PROCEDURE

pMDI + charcoal block

Aerochamber Plus spacer DEVICE

pMDI + Aerochamber Plus

pMDI standard actuator DRUG

pMDI

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex: male
• ≤age≤45 years old
• BMI: 18≤BMI≤28 kg/m2
• Non-smokers
• Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm, measured after 5 min of rest in the sitting position
• Full comprehension: ability to use correctly the pMDI preparations; ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study

You may not qualify if:

• ECG (12 leads): clinically relevant abnormalities and/or QTc \>450 msec;
• Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study; in particular any abnormality in the lung functionality: FEV1 \<80% predicted values according to European Respiratory Society basing upon Quanjer et al. (25)
• Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; in particular positive HIV1 and HIV2 serology and/or positive hepatitis serology indicating acute or chronic hepatitis B or C
• Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
• Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
• Medications: medication, including OTC, during 2 weeks before the start of the study. Any known enzyme inducing drug or enzyme inhibitor must be stopped at least 2 months before study start
• Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the screening
• Blood donation: blood donations during the 3 months prior to this study
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>2 drinks/day, defined according to USDA Dietary Guidelines 2005 (26)\], caffeine (\>5 cups coffee/tea/day) abuse or smoking
• Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead
• Cross Research S.A.: collaborator

Study Sites (1)

CROSS Research SA

Arzo, Via F.A. Giorgioli, 14, 6864, Switzerland

Location

Related Publications (1)

• Singh D, Collarini S, Poli G, Acerbi D, Amadasi A, Rusca A. Effect of AeroChamber Plus on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI. Br J Clin Pharmacol. 2011 Dec;72(6):932-9. doi: 10.1111/j.1365-2125.2011.04024.x.

  PMID: 21615456 RESULT

MeSH Terms

Conditions

Anthrax

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Antonio Rusca, MD, FMH

  CROSS Research SA

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 20, 2011
• Study Start: December 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

CH (1)