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

NCT ID: NCT01634139

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tiotropium high dose QD

Group Type: EXPERIMENTAL

Tiotropium high dose QD

Intervention Type: DRUG

2 actuations once daily in the evening

Tiotropium low dose QD

Group Type: EXPERIMENTAL

Tiotropium low dose QD

Intervention Type: DRUG

2 actuations once daily in the evening

Placebo QD

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

2 actuations once daily in the evening

Interventions

Tiotropium low dose QD

2 actuations once daily in the evening

Intervention Type: DRUG

Tiotropium high dose QD

2 actuations once daily in the evening

Intervention Type: DRUG

Placebo

2 actuations once daily in the evening

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Male or female patients between 6 and 11 years of age.

3. All patients must have at least a 6-month history of asthma.

4. 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.

5. 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.

6. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) >= 60% and =< 90% of predicted normal at Visit 1.

7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.

8. 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.

9. Patients must be able to use the Respimat inhaler correctly.

10. 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).

Exclusion Criteria

1. Patients with a significant disease other than asthma.

2. Patients with a clinically relevant abnormal haematology or blood chemistry at screening.

3. 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.

4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.

5. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.

6. Patients with known active tuberculosis.

7. Patients who have undergone thoracotomy with pulmonary resection.

8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.

9. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the inhalation solution used with the Respimat inhaler.

10. Pregnant or nursing female patients, including postmenarchal girl with a positive urine pregnancy test at Visit 1.

11. Postmenarchal girl of child-bearing potential not using a highly effective method of birth control.

12. Patients who have been treated with anti-IgE treatment within the last six months prior to Visit 1 and/or during the screening period.

13. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1.

14. Patients who have been treated with systemic beta-adrenergics within four weeks prior to Visit 1.

15. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period.

16. Patients who have been treated with inhaled long-acting anticholinergics or systemic anticholinergic treatment within four weeks prior to Visit 1 and/or during the screening period or who have been treated with inhaled short-acting anticholinergics within two weeks prior to Visit 1.

17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Visit 1 and/or during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Visit 1.

18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.

19. Patients who have taken an investigational drug within six half lives according to the investigator's information, or four weeks (whichever is greater) prior to Visit 1 and/or during the screening period.

20. Patients who have previously been randomised in this trial or are currently participating in another trial.

21. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1 and /or in four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.

22. Patients requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.

23. Patients who are unable to comply with medication restrictions prior to Visit 1 and or Visit 2.

24. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.

25. 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

205.445.01002 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

205.445.01001 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

205.445.01010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

205.445.01006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

205.445.01012 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

205.445.01004 Boehringer Ingelheim Investigational Site

El Paso, Texas, United States

205.445.35901 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

205.445.35902 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

205.445.35903 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

205.445.35904 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

205.445.35905 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

205.445.02003 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

205.445.02001 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

205.445.49012 Boehringer Ingelheim Investigational Site

Berlin, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Dresden, , Germany

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Ettenheim, , Germany

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Koblenz, , Germany

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Marburg, , Germany

205.445.50201 Boehringer Ingelheim Investigational Site

Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Guatemala City, , Guatemala

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Ajka, , Hungary

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Budapest, , Hungary

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Dombóvár, , Hungary

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Ādaži, , Latvia

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Baldone, , Latvia

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Balvi, , Latvia

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Daugavpils, , Latvia

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Ogre, , Latvia

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Rēzekne, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Šiauliai, , Lithuania

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Utena, , Lithuania

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Vilnius, , Lithuania

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Oslo, , Norway

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Amadora, , Portugal

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Aveiro, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

205.445.70011 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Guri-si, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Sungnam, , South Korea

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Stockholm, , Sweden

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Chernivtsi, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kryvyi Rih, , Ukraine

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Lviv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhya, , Ukraine

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Zaporizhzhya, , Ukraine

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London, , United Kingdom

Countries

United States; Bulgaria; Canada; Germany; Guatemala; Hungary; Latvia; Lithuania; Norway; Portugal; Romania; Russia; South Korea; Sweden; Ukraine; United Kingdom

Other Identifiers

2011-001758-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.445

Identifier Type: -

Identifier Source: org_study_id