Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Foster BDP/Formoterol; Drug: CHF 1535 Next DPI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868023

CCD-0809-PR-0038

2008-004842-10 (EudraCT Number)

Details and patient eligibility

About

Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Full description

To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient's written informed consent obtained prior to any study-related procedures.
• Outpatient male or female aged ≥ 18 years.
• Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
• Under previous inhaled corticosteroids (ICS) treatment at the screening visit
• Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
• A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
• Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
• Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
• Non-smokers or ex-smokers

Exclusion criteria

• Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
• Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
• History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
• Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
• Diagnosis of restrictive lung disease.
• Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
• Allergy, sensitivity or intolerance to study drugs or excipients.
• Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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69 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

CHF 1535 DPI : BDP/Formo 400/24 µg

Treatment:

Drug: CHF 1535 Next DPI

Drug: CHF 1535 Next DPI

2

Active Comparator group

Description:

CHF 1535 pMDI HFA : BDP/Formo 400/24 µg

Treatment:

Drug: Foster BDP/Formoterol

Drug: Foster BDP/Formoterol

3

Experimental group

Description:

CHF 1535 DPI : BDP/Formo 100/6 µg

Treatment:

Drug: CHF 1535 Next DPI

Drug: CHF 1535 Next DPI

4

Active Comparator group

Description:

CHF 1535 pMDI HFA : BDP/Formo 100/6 µg

Treatment:

Drug: Foster BDP/Formoterol

Drug: Foster BDP/Formoterol

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo