Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

NCT02030535 | Completed Phase 2 Results

• 2 other identifiers: 1237.72013-002652-32
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration

  The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)). For patients who did not complete all periods, patient baseline was the average of the available period baselines. The means presented are the adjusted means.

  1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose

Secondary Outcomes (20)

• Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points

  40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose

• Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points

  40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose

• Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points

  40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose

• Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points

  40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose

• Heart Rate Change From Patient Baseline at Individual Post-dose Time Points

  40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose

Study Arms (3)

Tiotropium/Olodaterol FDC

EXPERIMENTAL

patient will receive tiotropium and olodaterol in a fixed dose combination

Drug: tiotropium; Drug: olodaterol

Tiotropium and Olodaterol FC

EXPERIMENTAL

patient will receive tiotropium and olodaterol in a free combination

Drug: olodaterol; Drug: tiotropium

Placebo

PLACEBO COMPARATOR

patient will receive placebo

Drug: Placebo

Interventions

olodaterol DRUG

free combination with tiotropium

Tiotropium and Olodaterol FC

tiotropium DRUG

free combination with olodaterol

Tiotropium and Olodaterol FC

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
• Patients must have a diagnosis of COPD and must meet the following spirometric criteria:
• Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1\>30% and \< 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC \<70% at Visit 1
• Male or female patients, 40 years of age or older.
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
• Patients who have never smoked cigarettes must be excluded.
• Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
• Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

You may not qualify if:

• Significant disease other than COPD
• Clinically relevant abnormal lab values.
• History of asthma.
• Diagnosis of thyrotoxicosis
• Diagnosis of paroxysmal tachycardia
• History of myocardial infarction within 1 year of screening visit
• 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 and patients with chronic respiratory failure
• History of cystic fibrosis
• Clinically evident bronchiectasis
• History of significant alcohol or drug abuse
• Thoracotomy with pulmonary resection

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

1237.7.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.7.49005 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.7.49007 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1237.7.49002 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1237.7.49003 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.7.49001 Boehringer Ingelheim Investigational Site

Weinheim, Germany

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

Limitations and Caveats

Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-06

Locations

DE (6)