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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535366
• Other study ID #: 1249.1
• Secondary ID: Eudract2007-0031
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2007
• Last updated: May 22, 2014
• Start date: October 2007

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: The Danish Medicine AgencyGermany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medical devices)Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
Oral inhalation by HandiHaler® device
• Salmeterol
Oral inhalation from Diskus®
• Fluticasone
Oral inhalation from metered dose inhaler (MDI)
• Ciclesonide low
Oral inhalation from MDI
• Ciclesonide high
Oral inhalation from MDI
• Placebo
Oral inhalation from MDI

Locations

Country	Name	City	State
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
Denmark	1249.1.45001 Boehringer Ingelheim Investigational Site	Aarhus C
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Netherlands, 

Outcome

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