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Triple in Asthma Dose Finding

NCT02127866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2026-04-14

Study results available
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Summary

Primary objective

The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42.

Key secondary objective

The key secondary objective was to evaluate the efficacy of the free combination CHF 5259 plus Foster® 100/6 μg by comparison with Foster® 100/6 μg in terms of peak FEV1 on Day 42.

Secondary objectives

The secondary objectives were:

* To evaluate the effect of the free combination of CHF 5259 plus Foster® 100/6 μg on other lung function parameters and on clinical outcome measures;
* To assess the safety and the tolerability of the study treatments.

Conditions

Interventions

DRUG

CHF 5259 plus Foster 100/6 µg

Comparison of different doses of CHF 5259 (on top of Foster 100/6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject was allocated to 3 out of the 4 possible treatments performed in sequence during a cross over design (incomplete block). All treatment medications were administered via pMDI. During each treatment period, treatment was administered as four puffs BID (morning and evening) approximately at the same time of the day.

DRUG

Foster 100/6 µg (four puffs BID)

Active comparator Treatment D = Foster 400 μg/24 μg (daily dose): patients followed a schedule of two puffs of CHF 5259 placebo BID and two puffs of Foster 100/6 μg BID. All treatment medications were administered via pMDI. During each of the 3 treatment periods, treatment was administered as four puffs BID (morning and evening) approximately at the same time of the day.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-11
Primary Completion
2015-03-08
Completion
2015-03-08

Countries

  • Bulgaria
  • Germany
  • Hungary
  • Italy
  • Poland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127866 on ClinicalTrials.gov