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

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108534
Enrollment
65
Registered
2017-04-11
Start date
2017-02-28
Completion date
2017-09-19
Last updated
2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGCHF1535 NEXThaler

Rescue treatment

DRUGCHF1535 pMDI

Rescue treatment

DRUGPlacebo

Rescue treatment

Sponsors

Chiesi Farmaceutici S.p.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in FEV1 5-min post-dose5 min post-doseChange in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)

Secondary

MeasureTime frameDescription
Change in FEV1 other time pointsUp to 30 min post-doseChange in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
FEV1 AUC0-10minFrom dosing to 10 min post-doseFEV1 area under the curve from dosing to 10 min post-dose
Time to recovery in FEV1From dosing to 30 min post-doseTime to return to 85% of baseline value
Change in Borg scaleUp to 30 min post-doseChange in Borg scale from the end of the methacholine challenge test
Time to recovery in Borg scaleUp to 30 min post-dose50% decrease from the post-methacholine challenge value

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026