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Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00535366
Enrollment
103
Registered
2007-09-26
Start date
2007-10-31
Completion date
Unknown
Last updated
2014-05-30

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 efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

Interventions

DRUGTiotropium

Oral inhalation by HandiHaler® device

DRUGSalmeterol

Oral inhalation from Diskus®

DRUGFluticasone

Oral inhalation from metered dose inhaler (MDI)

DRUGCiclesonide low

Oral inhalation from MDI

DRUGCiclesonide high

Oral inhalation from MDI

DRUGPlacebo

Oral inhalation from MDI

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Relatively stable, moderate to severe COPD * Male or female patients 40 years of age or older. * Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion criteria

* Other significant disease that can influence the study results or be a safety risk for the patient * Other medication that can influence the study results * Hypersensitivity to the study medication * Patients with unstable COPD

Design outcomes

Primary

MeasureTime frame
Trough FEV1 response at the end of each 4 week period of randomised treatment4 weeks

Secondary

MeasureTime frame
All adverse events24 weeks
Pulse rate and blood pressure (seated)24 weeks
FEV1 and FVC morning peak responseday 1 and day 28 of each blinded treatment
FEV1 and FVC evening peak responseday 1 and day 28 of each blinded treatment
FEV1 AUC (0-3h), after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment
FEV1 AUC (12-15h) after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment
FVC AUC (12-15h) after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment
Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment periodday 1 and day 28 of each blinded treatment
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)28 weeks
Weekly mean number of occasions of rescue therapy used per day28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment
FVC AUC (0-3h) after 4 weeks of each blinded treatmentafter 4 weeks of each blinded treatment

Countries

Belgium, Denmark, Germany, Netherlands

Outcome results

None listed

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