A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

Asthma Clinical Trial

Official title:

A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108534
• Other study ID #: CCD-01535BD1-01
• Secondary ID: 2016-003672-47
• Status: Completed
• Phase: Phase 2
• Start date: February 28, 2017
• Est. completion date: September 19, 2017

Study information

• Verified date: October 2018
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 19, 2017
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Informed consent form obtained

• Minimum required Peak Inspiratory Flow (PIF) to activate NEXThaler

• Pre-bronchodilator FEV1 of at least 65%

• Positive response to methacholine challenge test

• Previous treatment with low-medium doses of Inhaled Corticosteroids (ICS) or ICS/Long-acting beta2-agonist (LABA) as per Global Initiative for Asthma (GINA) 2016 guidelines

• For females: non-pregnant, non-lactacting and using highly effective contraceptive methods.

Exclusion Criteria:

• Clinically relevant and uncontrolled concomitant diseases

• Abnormal clinically relevant ECG

• Presence of aortic aneurism

• Uncontrolled hypertension

• Intake of non-permitted concomitant medications

• Participation in another clinical trials in the previous 8 weeks

• Seasonal variation in asthma

• Recent occurrence of asthma exacerbations

• Hypersensitivity to any product used in the trial, including excipients

• Heavy caffeine drinkers

• History of alcohol/drug abuse

• Smokers

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF1535 NEXThaler
Rescue treatment
• CHF1535 pMDI
Rescue treatment
• Placebo
Rescue treatment

Locations

Country	Name	City	State
United Kingdom	University of Dundee	Dundee
United Kingdom	Hammersmith Medicines Research	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	Change in FEV1 5-min post-dose	Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)	5 min post-dose
Secondary	Change in FEV1 other time points	Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)	Up to 30 min post-dose
Secondary	FEV1 AUC0-10min	FEV1 area under the curve from dosing to 10 min post-dose	From dosing to 10 min post-dose
Secondary	Time to recovery in FEV1	Time to return to 85% of baseline value	From dosing to 30 min post-dose
Secondary	Change in Borg scale	Change in Borg scale from the end of the methacholine challenge test	Up to 30 min post-dose
Secondary	Time to recovery in Borg scale	50% decrease from the post-methacholine challenge value	Up to 30 min post-dose

External Links

•   Study Record on EU Clinical Trials Register including results