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

A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: CHF 1535 Next DPI; Drug: CHF 1535 Next DPI; Drug: Foster BDP/Formoterol; Drug: Foster BDP/Formoterol

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Pr DS SINGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 5; Placebo	Drug: Placebo; Placebo
Experimental: 1; CHF 1535 DPI : BDP/Formo 400/24 µg	Drug: CHF 1535 Next DPI; CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg); Drug: CHF 1535 Next DPI; CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
Active Comparator: 2; CHF 1535 pMDI HFA : BDP/Formo 400/24 µg	Drug: Foster BDP/Formoterol; BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg); Drug: Foster BDP/Formoterol; BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
Experimental: 3; CHF 1535 DPI : BDP/Formo 100/6 µg	Drug: CHF 1535 Next DPI; CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg); Drug: CHF 1535 Next DPI; CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
Active Comparator: 4; CHF 1535 pMDI HFA : BDP/Formo 100/6 µg	Drug: Foster BDP/Formoterol; BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg); Drug: Foster BDP/Formoterol; BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1 AUC0-12h	Every week

Secondary Outcome Measures

Outcome Measure	Time Frame
FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation	Every week

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: David Singh, Professor, Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 23, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate
• Other Study ID Numbers: CCD-0809-PR-0038; 2008-004842-10 (EudraCT Number)