A randomized, multi-center, placebo controlled 24 week study to compare the efficacy and safety of formoterol Certihaler™ 10µg b.i.d., tiotropium HandiHaler® 18µg o.d. and tiotropium HandiHaler® 18µg o.d. in combination with formoterol Certihaler™ 10µg b.i.d. in patients with stable Chronic Obstructive Pulmonary Disease. - Not applicable

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002089-39-HU

Enrollment

800

Registered

2004-08-27

Start date

2004-10-20

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Stable chronic obstructive pulmonary disease Classification code 10010952

Interventions

Product Name: Foradil Certihaler Product Code: FOR258F Pharmaceutical Form: Inhalation powder INN or Proposed INN: Formoterol CAS Number: 43229-80-7 Current Sponsor code: CGP25827A Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients =40 years with moderate COPD. A current or previous smoking history of =10 pack years. Prebronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy, nursing mothers and females of child-bearing potential. Hospitalisation for an acute exacerbation in the month priot to visit 1 or during screening. Respiratory tract infection within 1 month prior to visit 1. Concommitant pulmonary disease including cancer(all), pulmonary TB or congenital bronchiectasis.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the efficacy of Foradil Certihaler 10µg b.i.d. is superior to placebo following 24 weeks treatment;Secondary Objective: a) To explore efficacy of tiotropium 18µg o.d. administered with Foradil Certihaler 10µg b.i.d. compared to tiotropium 18µg o.d. b) To explore the onset of action of Foradil Certihaler 10µg b.i.d. compared to tiotropium 18µg o.d.;Primary end point(s): FEV1 measured 2 h post dosing following 24 weeks treatment.	—

Measure

Time frame

Main Objective: To demonstrate that the efficacy of Foradil Certihaler 10µg b.i.d. is superior to placebo following 24 weeks treatment;Secondary Objective: a) To explore efficacy of tiotropium 18µg o.d. administered with Foradil Certihaler 10µg b.i.d. compared to tiotropium 18µg o.d. b) To explore the onset of action of Foradil Certihaler 10µg b.i.d. compared to tiotropium 18µg o.d.;Primary end point(s): FEV1 measured 2 h post dosing following 24 weeks treatment.

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Countries

Czech Republic, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026