NCT01383499

Brief Summary

The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started Aug 2011

Geographic Reach
6 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 30, 2013

Completed
Last Updated

April 15, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

June 20, 2011

Results QC Date

September 23, 2013

Last Update Submit

March 26, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume (FEV1) Peak (0-3h) Response

    The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.

    Baseline and 4 weeks

Secondary Outcomes (10)

  • Trough FEV1 Response

    Baseline and 4 weeks

  • Forced Vital Capacity (FVC) Peak (0-3h) Response

    Baseline and 4 weeks

  • FVC Trough Response

    Baseline and 4 weeks

  • FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response

    Baseline and 4 weeks

  • FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response

    Baseline and 4 weeks

  • +5 more secondary outcomes

Study Arms (4)

Treatment A

EXPERIMENTAL

patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler

Drug: Tiotropium bromide

Treatment B

EXPERIMENTAL

patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler

Drug: Tiotropium bromide

Treatment C

EXPERIMENTAL

patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler

Drug: Tiotropium bromide

Treatment D

PLACEBO COMPARATOR

patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler

Drug: Tiotropium bromide

Interventions

Tiotropium bromideDRUG

inhalation solution administered via Respimat in 3 different doses

Treatment D

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients' parents (or legally accepted caregivers) must sign and date an informed consent prior to any study procedures including medication washout and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients.
  • Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).
  • All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.
  • All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose - a patient is eligible on =200 µg to =400 µg Budesonide DPI or equivalent.
  • All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of =1.5.
  • All patients must have a pre-bronchodilator FEV1 =60% and =90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 2 (pre-dose) as compared to values at Visit 2 (pre-bronchodilator) must be within ± 30%.
  • All patients must demonstrate an increase in FEV1 of =12% 15 to 30 min. after 200 µg salbutamol (albuterol) at Visit 1.
  • Patients must be able to inhale from the Respimat® inhaler correctly.
  • Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to current ATS/ERS standards and the use of the electronic diary/peak flow meter.

You may not qualify if:

  • Patients with any of the following characteristics will not be eligible for entry into this study:
  • Patients with a significant disease other than asthma.
  • Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
  • Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation, catheter ablation etc.) 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 clinically significant lung diseases other than asthma, such as CF, or bronchopulmonary dysplasia.
  • Patients with known active tuberculosis.
  • Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
  • Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
  • Patients with known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
  • Patients with moderate to severe renal impairment, as defined by a creatinine clearance \<50 mL/min./1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

205.425.49005 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

205.425.49004 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

205.425.49002 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

205.425.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

205.425.36003 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

205.425.36002 Boehringer Ingelheim Investigational Site

Mosdós, Hungary

Location

205.425.36004 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

205.425.37101 Boehringer Ingelheim Investigational Site

Baldone, Latvia

Location

205.425.37105 Boehringer Ingelheim Investigational Site

Balvi, Latvia

Location

205.425.37104 Boehringer Ingelheim Investigational Site

Daugavpils, Latvia

Location

205.425.37106 Boehringer Ingelheim Investigational Site

Dubulti, Latvia

Location

205.425.37102 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

205.425.37103 Boehringer Ingelheim Investigational Site

Riga, Latvia

Location

205.425.37004 Boehringer Ingelheim Investigational Site

Kaunas, Lithuania

Location

205.425.37003 Boehringer Ingelheim Investigational Site

Tauragė, Lithuania

Location

205.425.37001 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.425.37002 Boehringer Ingelheim Investigational Site

Vilnius, Lithuania

Location

205.425.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.425.07004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.425.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.425.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.425.38002 Boehringer Ingelheim Investigational Site

Donetsk, Ukraine

Location

205.425.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

205.425.38003 Boehringer Ingelheim Investigational Site

Zaporizhya, Ukraine

Location

Related Publications (1)

  • Vogelberg C, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Hamelmann E, Engel M, Szefler S. A randomised dose-ranging study of tiotropium Respimat(R) in children with symptomatic asthma despite inhaled corticosteroids. Respir Res. 2015 Feb 7;16(1):20. doi: 10.1186/s12931-015-0175-9.

    PMID: 25851298DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 28, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 15, 2015

Results First Posted

December 30, 2013

Record last verified: 2015-03

Locations

DE(3)LI(4)HU(4)RU(4)UA(3)LA(6)