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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: Tiotropium (Drug); Salmeterol (Drug); Fluticasone (Drug); Ciclesonide low (Drug); Ciclesonide high (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Trough FEV1 response at the end of each 4 week period of randomised treatment

Secondary outcome:

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

All adverse events

Pulse rate and blood pressure (seated)

FEV1 and FVC morning peak response

FEV1 and FVC evening peak response

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

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

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

FVC AUC (12-15h) after 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 period

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

Weekly mean number of occasions of rescue therapy used per day

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

Fractional exhaled nitric oxide after 4 weeks of each blinded treatment

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

1249.1.45001 Boehringer Ingelheim Investigational Site, Aarhus C, Denmark

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

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

Additional Information

Starting date: October 2007
Last updated: May 22, 2014

Page last updated: August 23, 2015

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