NCT01070524

Brief Summary

Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

February 17, 2010

Last Update Submit

March 28, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Trough FEV1 (mean 23h-24h FEV1)

    after day 28 dose

Secondary Outcomes (4)

  • Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)

    after day 1 dose

  • Trough FVC (mean 23-24h)

    after day 28 dose

  • Peak FEV1 and FVC

    on day 1 and day 28

  • FEV1 AUC0-24

    after day 1 and day 28

Study Arms (3)

CHF 5188 pMDI

EXPERIMENTAL
Drug: CHF 5188 pMDI

Budesonide extrafine pMDI

ACTIVE COMPARATOR
Drug: Budesonide extrafine pMDI

Seretide(r) Evohaler(r)

ACTIVE COMPARATOR
Drug: Seretide(r) Evohaler(r)

Interventions

CHF 5188 pMDIDRUG

CHF 5188: fixed combination budesonide/carmoterol

CHF 5188 pMDI
Budesonide extrafine pMDIDRUG

Budesonide extrafine pMDI

Budesonide extrafine pMDI
Seretide(r) Evohaler(r)DRUG

Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

Seretide(r) Evohaler(r)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate or severe asthma partly controlled with ICS or ICS/LABA
  • FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

You may not qualify if:

  • Diagnosis of COPD
  • History or current evidence of significant cardiovascular disease
  • Uncontrolled concomitant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road

Manchester, M23 9QZ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dave Singh, MD

    The Medicines Evaluation Unit Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

GB(1)