A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

NCT02148120 | Completed Phase 2

• 1 other identifier: CCD-01535BA1-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• FEV1 Area under the curve

  FEV1= Forced expiratory volume in the first second of expiration

  until 12 h post dose

Secondary Outcomes (4)

• FEV1 peak

  until 12 h post dose

• FVC area under the curve

  until 12 h post dose

• FVC peak

  until 12 h post dose

• Adverse events

  over a period of 5 to 14 weeks

Study Arms (5)

CHF1535 NEXThaler 100/6, 1 puff

ACTIVE COMPARATOR

Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

CHF1535 NEXThaler 100/6 µg, 4 puffs

ACTIVE COMPARATOR

Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg

Drug: Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

CHF1535 NEXThaler 200/6 µg, 1 puff

EXPERIMENTAL

Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg

Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg

CHF1535 NEXThaler 200/6 µg, 4 puffs

EXPERIMENTAL

Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg

Drug: Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg

Placebo NEXThaler

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg DRUG

Also known as: Foster NEXThaler

CHF1535 NEXThaler 100/6 µg, 4 puffs; CHF1535 NEXThaler 100/6, 1 puff

Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg DRUG

CHF1535 NEXThaler 200/6 µg, 1 puff; CHF1535 NEXThaler 200/6 µg, 4 puffs

Placebo DRUG

Placebo NEXThaler

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (3)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

Respiratory Clinical Trials, Hearth Lung Centre

London, W1G 8HU, United Kingdom

Location

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

GB (3)