Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658255

Enrollment

175

Registered

2008-04-14

Start date

2002-10-31

Completion date

2003-05-31

Last updated

2011-01-24

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

Conditions

Stable Asthma

Keywords

stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation

Brief summary

The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Interventions

DRUGbudesonide/formoterol

DRUGformoterol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 18 years of age * Diagnosis of asthma and baseline lung function tests as determined by the protocol * Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion criteria

* Severe asthma * Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Design outcomes

Primary

Measure	Time frame
Average FEV1 during 12 hours	Once a week for 5 weeks during treatment period

Secondary

Measure	Time frame
Urine levels of formoterol in 2 different formulations	Once a week (12 hour urine collection) for 5 weeks during treatment period
Safety profiles of formoterol in 2 different formulations	Once a week for 5 weeks during treatment period

Outcome results

None listed

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