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Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

NCT01048333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2012-10-25

Study results available
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Summary

* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
* Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

Conditions

Interventions

DRUG

Formoterol

Formoterol Turbuhaler 9 μg and Placebo Diskus

DRUG

Salmeterol

Salmeterol Diskus 50 μg and Placebo Turbuhaler

DRUG

Placebo

Placebo Diskus and Placebo Turbuhaler

Sponsors & Collaborators

Principal Investigators

  • Mario Cazzola, professor · Italy

  • Georgios Stratelis · AstraZeneca MC Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Italy
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01048333 on ClinicalTrials.gov