Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma

NCT ID: NCT01634113

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

Brief Summary

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

Conditions

Asthma

Study Design

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

Study Groups

tiotropium low dose

Once daily, delivered with Respimat® inhaler

Group Type: EXPERIMENTAL

tiotropium-bromide

Intervention Type: DRUG

IMP

tiotropium high dose

Once daily, delivered with Respimat® inhaler

Group Type: EXPERIMENTAL

tiotropium-bromide

Intervention Type: DRUG

IMP

placebo

Once daily, delivered with Respimat® inhaler

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo matching tiotropium

Interventions

tiotropium-bromide

IMP

Intervention Type: DRUG

tiotropium-bromide

IMP

Intervention Type: DRUG

placebo

placebo matching tiotropium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.

2. Male or female patients between 1 and 5 years of age.

3. By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)

4. For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).

5. All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.

6. All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2).

Exclusion Criteria

1. Patients with a significant disease other than asthma.

2. Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.

3. 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.

4. Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) 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.

6. Patients with clinically significant lung diseases other than asthma.

7. Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.

8. Patients with known active tuberculosis.

9. Patients who have undergone thoracotomy with pulmonary resection.

10. 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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 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

205.443.12003 Boehringer Ingelheim Investigational Site

Columbia, Missouri, United States

205.443.12005 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

205.443.12006 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

205.443.12004 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

205.443.01004 Boehringer Ingelheim Investigational Site

Antwerp, , Belgium

205.443.01002 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

205.443.01001 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

205.443.02002 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

205.443.02003 Boehringer Ingelheim Investigational Site

Turku, , Finland

205.443.03003 Boehringer Ingelheim Investigational Site

Berlin, , Germany

205.443.03001 Boehringer Ingelheim Investigational Site

Bochum, , Germany

205.443.03002 Boehringer Ingelheim Investigational Site

Ettenheim, , Germany

205.443.03010 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

205.443.05001 Boehringer Ingelheim Investigational Site

Balvi, , Latvia

205.443.05003 Boehringer Ingelheim Investigational Site

Rēzekne, , Latvia

205.443.05002 Boehringer Ingelheim Investigational Site

Riga, , Latvia

205.443.06002 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

205.443.06003 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

205.443.10002 Boehringer Ingelheim Investigational Site

Kelantan, , Malaysia

205.443.10001 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

205.443.10003 Boehringer Ingelheim Investigational Site

Kuala Pahang, , Malaysia

205.443.04003 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

205.443.04001 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

205.443.09001 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

205.443.09002 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

205.443.82003 Boehringer Ingelheim Investigational Site

Guri-si, , South Korea

205.443.82002 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

205.443.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

205.443.07003 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, , Ukraine

205.443.07002 Boehringer Ingelheim Investigational Site

Donetsk, , Ukraine

205.443.07005 Boehringer Ingelheim Investigational Site

Vinnytsia, , Ukraine

205.443.07004 Boehringer Ingelheim Investigational Site

Zaporizhya, , Ukraine

205.443.07001 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Countries

United States; Belgium; Finland; Germany; Latvia; Lithuania; Malaysia; Netherlands; Philippines; South Korea; Ukraine

References

Wachtel H, Nagel M, Engel M, El Azzi G, Sharma A, Suggett J. In vitro and clinical characterization of the valved holding chamber AeroChamber Plus(R) Flow-Vu(R) for administrating tiotropium Respimat(R) in 1-5-year-old children with persistent asthmatic symptoms. Respir Med. 2018 Apr;137:181-190. doi: 10.1016/j.rmed.2018.03.010. Epub 2018 Mar 7.

Reference Type: DERIVED

PMID: 29605203 (View on PubMed)

Vrijlandt EJLE, El Azzi G, Vandewalker M, Rupp N, Harper T, Graham L, Szefler SJ, Moroni-Zentgraf P, Sharma A, Vulcu SD, Sigmund R, Chawes B, Engel M, Bisgaard H. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2018 Feb;6(2):127-137. doi: 10.1016/S2213-2600(18)30012-2. Epub 2018 Jan 18.

Reference Type: DERIVED

PMID: 29361462 (View on PubMed)

Other Identifiers

2011-005512-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.443

Identifier Type: -

Identifier Source: org_study_id