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.

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

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source Chiesi Farmaceutici S.p.A.
Brief 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.

Overall Status Completed
Start Date February 28, 2017
Completion Date September 19, 2017
Primary Completion Date September 19, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in FEV1 5-min post-dose 5 min post-dose
Secondary Outcome
Measure Time Frame
Change in FEV1 other time points Up to 30 min post-dose
FEV1 AUC0-10min From dosing to 10 min post-dose
Time to recovery in FEV1 From dosing to 30 min post-dose
Change in Borg scale Up to 30 min post-dose
Time to recovery in Borg scale Up to 30 min post-dose
Enrollment 65
Condition
Intervention

Intervention type: Drug

Intervention name: CHF1535 NEXThaler

Description: Rescue treatment

Arm group label: CHF1535 NEXThaler

Other name: Foster NEXThaler

Intervention type: Drug

Intervention name: CHF1535 pMDI

Description: Rescue treatment

Arm group label: CHF1535 pMDI

Other name: Foster

Intervention type: Drug

Intervention name: Placebo

Description: Rescue treatment

Arm group label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Location
facility
University of Dundee | Dundee, United Kingdom
Hammersmith Medicines Research | London, United Kingdom
Medicines Evaluation Unit | Manchester, United Kingdom
Location Countries

United Kingdom

Verification Date

October 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: CHF1535 NEXThaler

Arm group type: Experimental

Description: CHF1535 100/6 NEXThaler (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)

Arm group label: CHF1535 pMDI

Arm group type: Active Comparator

Description: CHF1535 100/6 pMDI (Beclometasone dipropionate 100 µg + formoterol fumarate 6 µg)

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Double dummy study: placebo is for both CHF1535 pMDI and CHF1535 NEXThaler

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov