Clinical trial NCT01738087: Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
Official title: A Phase II, Monocentric, Open, Randomized, 6-way Cross-over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate 100/6 mcg and 200 mcg) Administered With and Without Activated Charcoal in Adult Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthmatic
Keywords: patients
Adult
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.

At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
* Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
* Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values
* Non or ex-smokers
* Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2

Exclusion Criteria:

* Pregnant or lactating women unless using acceptable methods of contraception
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of near fatal asthma
* Patients with abnormal QTcF at screening Visit
* Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
* Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
* History of drug addiction or excessive use of alcohol ;
* Diagnosis of restrictive lung disease.
* Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
* Significant medical history or any laboratory abnormality indicative of a significant underlying condition

Primary outcomes:
measure: Formoterol AUC0-t and B17MP AUC0-t
timeFrame: from predose until 12 hr post dose
Secondary outcomes:
measure: BDP pharmacokinetic (PK) parameters
timeFrame: from predose until 12 hr post dose
measure: Other PK parameter of B17MP and formoterol
timeFrame: from predose until 12 hours postdose
Other outcomes:
measure: Plasma glucose
timeFrame: from predose until 12 hours postdose
measure: Heart rate (HR)
timeFrame: from predose until 12 hours postdose
measure: Plasma cortisol
timeFrame: from predose until 24 hours postdose
measure: Plasma potassium
timeFrame: from predose until 12 hours postdose
measure: Systolic and Diastolic Blood Pressure (SBP and DBP)
timeFrame: from predose until 12 hours postdose
Locations:
city: Manchester
country: United Kingdom
facility: The Medicine Evaluation Unit
Study officials:
References: