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Completed

NCT Number: NCT00535366

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1249.1.32003 Boehringer Ingelheim Investigational Site, Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium

Drug

Oral inhalation by HandiHaler® device

Salmeterol

Drug

Oral inhalation from Diskus®

Fluticasone

Drug

Oral inhalation from metered dose inhaler (MDI)

Ciclesonide low

Drug

Oral inhalation from MDI

Ciclesonide high

Drug

Oral inhalation from MDI

Placebo

Drug

Oral inhalation from MDI

Primary outcomes

  1. Trough FEV1 response at the end of each 4 week period of randomised treatment

    Time frame: 4 weeks

Secondary outcomes

  1. Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

  2. All adverse events

    Time frame: 24 weeks

  3. Pulse rate and blood pressure (seated)

    Time frame: 24 weeks

  4. FEV1 and FVC morning peak response

    Time frame: day 1 and day 28 of each blinded treatment

  5. FEV1 and FVC evening peak response

    Time frame: day 1 and day 28 of each blinded treatment

  6. FEV1 AUC (0-3h), after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

  7. FEV1 AUC (12-15h) after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

  8. FVC AUC (0-3h) after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

  9. FVC AUC (12-15h) after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

  10. Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period

    Time frame: day 1 and day 28 of each blinded treatment

  11. Weekly mean pre-dose morning and evening peak expiratory flow (PEF)

    Time frame: 28 weeks

  12. Weekly mean number of occasions of rescue therapy used per day

    Time frame: 28 weeks

  13. Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period

    Time frame: 28 weeks

  14. Fractional exhaled nitric oxide after 4 weeks of each blinded treatment

    Time frame: after 4 weeks of each blinded treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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.

Important dates

Study start
2007
Primary completion
2008
First posted
Sep 26, 2007
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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