NCT01344655

Brief Summary

This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2011

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

First Submitted

Initial submission to the registry

November 29, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

November 29, 2010

Last Update Submit

March 28, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Respiratory Impedance by Impulse oscillometry

    from 5 minutes to 8 hours post dose

Secondary Outcomes (3)

  • Exhaled Nitric Oxide

    from 30 minutes to 8 hours post dose

  • Multiple Breath Nitrogen Washout

    from 30 minutes to 8 hours post dose

  • Forced Expiratory Volume in the 1st second

    from 30 minutes to 8 hours post dose

Study Arms (3)

Formoterol 12 μg pMDI (Atimos®)

EXPERIMENTAL
Drug: Atimos®

Salmeterol 25 µg pMDI HFA (Serevent™)

ACTIVE COMPARATOR
Drug: Serevent™

Matched Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Atimos®DRUG

Formoterol 12 μg pMDI

Formoterol 12 μg pMDI (Atimos®)
Serevent™DRUG

Salmeterol 25 µg pMDI

Salmeterol 25 µg pMDI HFA (Serevent™)
PlaceboDRUG

placebo

Matched Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical diagnosis of COPD
  • Post bronchodilator FEV1 between 30% and 80% predicted values at screening
  • Post-bronchodilator FEV1/FVC \< 0.7

You may not qualify if:

  • Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
  • History of another medical condition contraindicating participation in the study
  • Clinical evidence of heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Airway Disease Section, NHLI, Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Omar S Usmani, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

April 29, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

GB(1)