Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma

NCT01634139 | Completed Phase 3 Results

• 2 other identifiers: 205.4452011-001758-26
• Study Type: interventional
• Target: 403
• Locations: 16 countries
• Sites: 79

Brief Summary

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• FEV1 Peak (0-3h) Change From Baseline

  Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24. Measured values presented are actually adjusted means. The number of participants analysed displays the number of participants with available data at the timepoint of interest.

  Baseline and 24 Weeks.

Secondary Outcomes (30)

• Trough FEV1 Change From Baseline

  Baseline and Week 24, Baseline and Week 48.

• FEV1 Peak (0-3h) at Week 48 Change From Baseline

  Baseline and Week 48.

• FEV1 AUC (0-3h) Change From Baseline

  Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24

• FEV1 Change From Baseline at Each Individual Timepoint

  Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks

• FVC Peak(0-3h) Change From Baseline

  Baseline and Week 24, Baseline and Week 48.

Study Arms (3)

Tiotropium high dose QD

EXPERIMENTAL

Drug: Tiotropium high dose QD

Tiotropium low dose QD

EXPERIMENTAL

Drug: Tiotropium low dose QD

Placebo QD

EXPERIMENTAL

Drug: Placebo

Interventions

Tiotropium low dose QD DRUG

2 actuations once daily in the evening

Tiotropium low dose QD

Tiotropium high dose QD DRUG

2 actuations once daily in the evening

Tiotropium high dose QD

Placebo DRUG

2 actuations once daily in the evening

Placebo QD

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients' parent(s) (or legal guardian) must sign and date an informed consent prior to participation in the trial. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent/assent is required for pharmacogenomic sampling.
• Male or female patients between 6 and 11 years of age.
• All patients must have at least a 6-month history of asthma.
• All patients must have been on maintenance treatment with an inhaled corticosteroid at a stable medium dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1. While the LTRA is permitted throughout the trial, the LABA has to be stopped at least 24 hours prior to Visit 1, as no LABAs are permitted during screening and treatment period of this trial.
• All patients must be symptomatic (partly controlled) at Visit 1 and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ-IA) mean score \>= 1.5.
• All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) \>= 60% and =\< 90% of predicted normal at Visit 1.
• Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
• All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of \>= 12%, 15 to 30 minutes after 200 mcg salbutamol/albuterol.
• Patients must be able to use the Respimat inhaler correctly.
• Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required).

You may not qualify if:

• Patients with a significant disease other than asthma.
• Patients with a clinically relevant abnormal haematology or blood chemistry at screening.
• Patients with a history of congenital or acquired heart disease, or patients who have been hospitalized for cardiac syncope or failure during the past year.
• Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
• Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
• Patients with known active tuberculosis.
• Patients who have undergone thoracotomy with pulmonary resection.
• Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.
• Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler.
• Pregnant or nursing female patients, including postmenarchal girl with a positive urine pregnancy test at Visit 1.
• Postmenarchal girl of child-bearing potential not using a highly effective method of birth control.
• Patients who have been treated with anti-IgE treatment within the last six months prior to Visit 1 and/or during the screening period.
• Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.
• Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.
• Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Pfizer: collaborator

Study Sites (79)

205.445.01002 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

Location

205.445.01001 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

205.445.01010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

205.445.01006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.445.01012 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Location

205.445.01004 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

Location

205.445.35901 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

205.445.35902 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

205.445.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

205.445.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

205.445.35905 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

205.445.02003 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

205.445.02001 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Location

205.445.49012 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.445.49015 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.445.49001 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

205.445.49007 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

205.445.49004 Boehringer Ingelheim Investigational Site

Ettenheim, Germany

Location

205.445.49009 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

205.445.49014 Boehringer Ingelheim Investigational Site

Marburg, Germany

Location

205.445.50201 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

205.445.50202 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

205.445.50203 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

205.445.50204 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

205.445.50205 Boehringer Ingelheim Investigational Site

Guatemala City, Guatemala

Location

205.445.36003 Boehringer Ingelheim Investigational Site

Ajka, Hungary

Location

205.445.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

205.445.36002 Boehringer Ingelheim Investigational Site

Dombóvár, Hungary

Location

205.445.37104 Boehringer Ingelheim Investigational Site

Ādaži, Latvia

Location

205.445.37101 Boehringer Ingelheim Investigational Site

Baldone, Latvia

Location

205.445.37106 Boehringer Ingelheim Investigational Site

Balvi, Latvia

Location

205.445.37108 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

205.445.37102 Boehringer Ingelheim Investigational Site

Ogre, Latvia

Location

205.445.37107 Boehringer Ingelheim Investigational Site

Rēzekne, Latvia

Location

205.445.37103 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

205.445.37105 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

205.445.37002 Boehringer Ingelheim Investigational Site

Šiauliai, Lithuania

Location

205.445.37005 Boehringer Ingelheim Investigational Site

Utena, Lithuania

Location

205.445.37003 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.445.47002 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

205.445.35108 Boehringer Ingelheim Investigational Site

Amadora, Portugal

Location

205.445.35106 Boehringer Ingelheim Investigational Site

Aveiro, Portugal

Location

205.445.35101 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.445.35102 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.445.35107 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

205.445.35103 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

205.445.35105 Boehringer Ingelheim Investigational Site

Porto, Portugal

Location

205.445.40001 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

205.445.40004 Boehringer Ingelheim Investigational Site

Bucharest, Romania

Location

205.445.40003 Boehringer Ingelheim Investigational Site

Cluj-Napoca, Romania

Location

205.445.70002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.445.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.445.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.445.70011 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.445.70001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.445.70003 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.445.70004 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.445.70009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.445.70010 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

205.445.82003 Boehringer Ingelheim Investigational Site

Guri-si, South Korea

Location

205.445.82002 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

205.445.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

205.445.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

205.445.82006 Boehringer Ingelheim Investigational Site

Sungnam, South Korea

Location

205.445.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

205.445.38017 Boehringer Ingelheim Investigational Site

Chernivtsi, Ukraine

Location

205.445.38003 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, Ukraine

Location

205.445.38005 Boehringer Ingelheim Investigational Site

Donetsk, Ukraine

Location

205.445.38011 Boehringer Ingelheim Investigational Site

Donetsk, Ukraine

Location

205.445.38008 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

205.445.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

205.445.38012 Boehringer Ingelheim Investigational Site

Kryvyi Rih, Ukraine

Location

205.445.38001 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

205.445.38009 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

205.445.38016 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

205.445.38006 Boehringer Ingelheim Investigational Site

Vinnytsia, Ukraine

Location

205.445.38010 Boehringer Ingelheim Investigational Site

Zaporizhya, Ukraine

Location

205.445.38002 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

205.445.44001 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Locations

KR (5); SE (1); UA (13); GB (1); US (6); BU (5); CA (2); LI (3); HU (3); PT (7); GU (5); DE (7); NO (1); RO (3); LA (8); RU (9)