Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

NCT02683109 | Completed Phase 4 Results

• 2 other identifiers: 1237.492015-003879-29
• Study Type: interventional
• Target: 221
• Locations: 5 countries
• Sites: 22

Brief Summary

This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study. Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment

  This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.

  Day 29

Secondary Outcomes (2)

• Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment

  Day 29

• Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28

  Day 28

Study Arms (2)

FDC of tiotropium + olodaterol

EXPERIMENTAL

Fixed Dose Combination of tiotropium + olodaterol

Drug: FDC of tiotropium + olodaterol; Drug: Placebo

Free combination tiotropium + olodaterol

ACTIVE COMPARATOR

Drug: Tiotropium; Drug: Olodaterol

Interventions

FDC of tiotropium + olodaterol DRUG

Fixed Dose Combination of tiotropium + olodaterol

FDC of tiotropium + olodaterol

Placebo DRUG

FDC of tiotropium + olodaterol

Tiotropium DRUG

Free combination tiotropium + olodaterol

Olodaterol DRUG

Free combination tiotropium + olodaterol

Eligibility Criteria

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

You may qualify if:

• Male or female patients.
• Patients 40 years of age or older.
• Patients with a smoking history \> 10 pack years.
• Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) \>= 30% and \<80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70% at screening.
• Symptomatic patients with CAT (COPD Assessment Test TM) score \>= 10 at screening.

You may not qualify if:

• COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
• Patients with a current diagnosis of asthma.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (22)

Ordination Dr. Robert Voves, 8330 Feldbach

Feldbach, 8330, Austria

Location

KH d. Elisabethinen Linz

Linz, 4020, Austria

Location

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Regionshospitalet Silkeborg

Silkeborg, 8600, Denmark

Location

Jorvin sairaala

Espoo, FI-02740, Finland

Location

HYKS Keuhkosairauksien

Helsinki, 00029, Finland

Location

TAYS, Keuhkotautien poliklinikka

Tampere, FI-33520, Finland

Location

TYKS, Keuhkosairauksien klinikka, Turku

Turku, 20520, Finland

Location

Terveystalo Pulssi, Turku

Turku, FI-20100, Finland

Location

HOP Louis Pradel

Bron, 69677, France

Location

CLI du Parc, Pneumo, Castelnau le Lez

Castelnau-le-Lez, 34170, France

Location

CAB Pigearias B., Pneumo, Nice

Nice, 06000, France

Location

CAB Dupouy J, Pneumo, Nîmes

Nîmes, 30900, France

Location

HOP Cochin

Paris, 75014, France

Location

HOP Haut-Lévêque

Pessac, 33604, France

Location

HOP Maison Blanche

Reims, 51092, France

Location

INS A.Tzanck,Pneumo,St Laurent du Var

Saint-Laurent-du-Var, 06721, France

Location

CAB Lejay D, MG, Vieux Condé

Vieux-Condé, 59690, France

Location

Univ. Clinic of Respiratory and Allergic Diseases, Golnik

Golnik, 4204, Slovenia

Location

Verboten Kopriva Renata - Private practice, Litija

Litija, 1270, Slovenia

Location

Arjana Macek d.o.o.

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol; Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; 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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 17, 2016
• Study Start: March 8, 2016
• Primary Completion: January 9, 2017
• Study Completion: January 30, 2017
• Last Updated: August 17, 2018
• Results First Posted: August 17, 2018

Record last verified: 2017-12

Locations

FR (9); AU (2); DK (3); FI (5); SL (3)