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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00535366
First received: September 25, 2007
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Drug: Salmeterol
Drug: Fluticasone
Drug: Ciclesonide low
Drug: Ciclesonide high
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough FEV1 response at the end of each 4 week period of randomised treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pulse rate and blood pressure (seated) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FEV1 and FVC morning peak response [ Time Frame: day 1 and day 28 of each blinded treatment ] [ Designated as safety issue: No ]
  • FEV1 and FVC evening peak response [ Time Frame: day 1 and day 28 of each blinded treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC (0-3h), after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC (12-15h) after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]
  • FVC AUC (0-3h) after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]
  • FVC AUC (12-15h) after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening peak expiratory flow (PEF) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Weekly mean number of occasions of rescue therapy used per day [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Fractional exhaled nitric oxide after 4 weeks of each blinded treatment [ Time Frame: after 4 weeks of each blinded treatment ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: October 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiotropium+salmeterol+fluticasone Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Fluticasone
Oral inhalation from metered dose inhaler (MDI)
Experimental: Tiotropium+salmeterol+ciclesonide low Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Ciclesonide low
Oral inhalation from MDI
Experimental: Tiotropium+salmeterol+ciclesonide high Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Ciclesonide high
Oral inhalation from MDI
Placebo Comparator: Placebo Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Placebo
Oral inhalation from MDI

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535366

Locations
Belgium
1249.1.32003 Boehringer Ingelheim Investigational Site
Genk, Belgium
1249.1.32001 Boehringer Ingelheim Investigational Site
Gent, Belgium
1249.1.32002 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
1249.1.32004 Boehringer Ingelheim Investigational Site
Oostende, Belgium
Denmark
1249.1.45001 Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
Germany
1249.1.49001 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1249.1.49002 Boehringer Ingelheim Investigational Site
Mannheim, Germany
1249.1.49003 Boehringer Ingelheim Investigational Site
Weinheim, Germany
Netherlands
1249.1.31002 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1249.1.31003 Boehringer Ingelheim Investigational Site
Harderwijk, Netherlands
1249.1.31001 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1249.1.31004 Boehringer Ingelheim Investigational Site
Veldhoven, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00535366     History of Changes
Other Study ID Numbers: 1249.1, Eudract2007-003169-42
Study First Received: September 25, 2007
Last Updated: May 22, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: The Danish Medicine Agency
Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical devices)
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Salmeterol
Fluticasone
Tiotropium
Ciclesonide
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Parasympatholytics

ClinicalTrials.gov processed this record on July 20, 2014