Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients

A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344655

Acronym

Imperial

Enrollment

Registered

2011-04-29

Start date

2011-04-30

Completion date

2012-09-30

Last updated

2017-03-30

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

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

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

Detailed description

A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Interventions

DRUGAtimos®

Formoterol 12 μg pMDI

DRUGSerevent™

Salmeterol 25 µg pMDI

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Respiratory Impedance by Impulse oscillometry	from 5 minutes to 8 hours post dose

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

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