A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148120
• Other study ID #: CCD-01535BA1-01
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2014
• Last updated: March 28, 2017
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg

• Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg

• Placebo

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London
United Kingdom	Respiratory Clinical Trials, Hearth Lung Centre	London
United Kingdom	Medicines Evaluation Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 Area under the curve	FEV1= Forced expiratory volume in the first second of expiration	until 12 h post dose
Secondary	FEV1 peak	Maximum FEV1 value	until 12 h post dose
Secondary	FVC area under the curve	FVC = Forced Vital Capacity	until 12 h post dose
Secondary	FVC peak	Maximum FVC	until 12 h post dose
Secondary	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

External Links

•   Study Record on EU Clinical Trials Register including results