Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

NCT01969721 | Completed Phase 3 Results

• 2 other identifiers: 1237.112013-000808-41
• Study Type: interventional
• Target: 229
• Locations: 8 countries
• Sites: 29

Brief Summary

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment

  Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) \[L\] after 6 weeks of treatment. Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.

  Baseline and 6 weeks.

Secondary Outcomes (4)

• FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment

  Baseline and 6 weeks.

• Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment

  Baseline and 6 weeks.

• FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment

  Baseline and 6 weeks.

• FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment

  Baseline and 6 weeks.

Study Arms (4)

T+O FDC dosage 1

EXPERIMENTAL

Low dose

Drug: olodaterol; Drug: placebo; Drug: tiotropium

T+O FDC dosage 2

EXPERIMENTAL

High dose

Drug: placebo; Drug: tiotropium; Drug: olodaterol

ICS/LABA FDC Dosage 1

ACTIVE COMPARATOR

Low dose

Drug: fluticasone propionate; Drug: salmeterol; Drug: placebo

ICS/LABA FDC Dosage 2

ACTIVE COMPARATOR

High dose

Drug: placebo; Drug: fluticasone propionate; Drug: salmeterol

Interventions

fluticasone propionate DRUG

low dose

ICS/LABA FDC Dosage 1

salmeterol DRUG

ICS/LABA FDC Dosage 1

placebo DRUG

placebo/dummy for blinding purposes

T+O FDC dosage 2

tiotropium DRUG

tiotropium high dose

T+O FDC dosage 2

olodaterol DRUG

T+O FDC dosage 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic obstructive pulmonary disease
• Relatively stable airway obstruction with a post-bronchodilator 30% \</= Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC \<70%
• Male or female patients, 40 years of age or older
• Smoking history of more than 10 pack years
• Ability to perform technically acceptable pulmonary function tests and maintain records
• Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)

You may not qualify if:

• Significant disease other than COPD
• COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
• Clinically relevant abnormal lab values
• History of asthma
• Diagnosis of thyrotoxicosis
• Diagnosis of paroxysmal tachycardia
• History of myocardial infarction
• Unstable or life-threatening cardiac arrhythmia
• Hospitalization for heart failure within the past year
• Known active tuberculosis
• malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• History of life-threatening pulmonary obstruction
• History of cystic fibrosis
• Clinically evident bronchiectasis
• History of significant alcohol or drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (29)

1237.11.32002 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1237.11.32001 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1237.11.42003 Boehringer Ingelheim Investigational Site

Kyjov, Czechia

Location

1237.11.42004 Boehringer Ingelheim Investigational Site

Rokycany, Czechia

Location

1237.11.42002 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1237.11.42001 Boehringer Ingelheim Investigational Site

Třebíč, Czechia

Location

1237.11.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1237.11.45004 Boehringer Ingelheim Investigational Site

Kolding, Denmark

Location

1237.11.45001 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1237.11.45003 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

1237.11.49003 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1237.11.49005 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.11.49001 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1237.11.49004 Boehringer Ingelheim Investigational Site

Mönchengladbach, Germany

Location

1237.11.49002 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

1237.11.36001 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1237.11.36004 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

1237.11.36003 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

1237.11.36002 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1237.11.31005 Boehringer Ingelheim Investigational Site

Almelo, Netherlands

Location

1237.11.31002 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1237.11.31006 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1237.11.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1237.11.31007 Boehringer Ingelheim Investigational Site

Hoorn, Netherlands

Location

1237.11.31003 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

Location

1237.11.34003 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1237.11.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1237.11.34002 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, Spain

Location

1237.11.46001 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2016-01

Locations

ES (3); HU (4); SE (1); DK (4); CZ (4); DE (5); NL (6); BE (2)