A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.

The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg; Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Hammersmith Medicines Research
  • London, United Kingdom, W1G 8HU
    • Respiratory Clinical Trials, Hearth Lung Centre
  • Manchester, United Kingdom, M23 9QZ
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (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.
• Male or female aged between 18 and 65 years inclusive;
• Evidence for "partially controlled" or "uncontrolled" asthma;
• Medium daily dose of previous inhaled corticosteroids (ICS) treatment;
• FEV1 between 60% and 85% of the predicted normal values;
• A documented positive response to the reversibility test;
• Non-smokers or ex-smokers;
• A cooperative attitude and ability to be trained in the proper use of a DPI.

Exclusion Criteria:

• Pregnant or lactating women and all women physiologically capable of becoming pregnant not willing to use at least one acceptable method of contraception.
• Significant seasonal variation in asthma occurring or expected to occur during study participation;
• History of near fatal asthma, brittle asthma, accident and Emergency treatment or 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;
• Diagnosis of Chronic Obstructive Pulmonary Disease;
• 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;
• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids;
• Allergy, sensitivity or intolerance to study drugs or excipients;
• Patients who received any investigational drug within the last 8 weeks before the screening;
• Patients taking any of the non-permitted concomitant medication;
• Subjects unlikely to comply with the study protocol;
• Any clinically relevant abnormal value or physical finding at screening;
• Significant medical history;
• Abnormal and clinically significant 12-lead electrocardiogram;
• Patients with low compliance of QVAR intake.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CHF1535 NEXThaler 100/6, 1 puff; Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg	Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg; Other Names: Foster NEXThaler
Active Comparator: CHF1535 NEXThaler 100/6 µg, 4 puffs; Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg	Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg; Other Names: Foster NEXThaler
Experimental: CHF1535 NEXThaler 200/6 µg, 1 puff; Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg	Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Experimental: CHF1535 NEXThaler 200/6 µg, 4 puffs; Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg	Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
Placebo Comparator: Placebo NEXThaler; Placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 Area under the curve	FEV1= Forced expiratory volume in the first second of expiration	until 12 h post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 peak	Maximum FEV1 value	until 12 h post dose
FVC area under the curve	FVC = Forced Vital Capacity	until 12 h post dose
FVC peak	Maximum FVC	until 12 h post dose
Adverse events	from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods.	over a period of 5 to 14 weeks

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 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: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Formoterol Fumarate
• Other Study ID Numbers: CCD-01535BA1-01