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Efficacy and Safety of tiotropium inhalation solution (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma (205.456)

PHRR121214-000036

205.456

2012-CT0040

A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma

This study, 205.456, is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

Start Date Duration in Months Target Completion Date Actual Completion Date
2012-04-13 15 2013-07-13 2014-07-24

Completed

Institution Classification Region LTO #
ICON Clinical Research Services Inc. Private Business NCR
Boehringer Ingelheim Singapore, Pte. Ltd. Private Business Singapore
Institution Classification Region LTO #
Boehringer Ingelheim Singapore, Pte. Ltd. Private Business Singapore
Institution Amount Region
Boehringer Ingelheim Singapore, Pte. Ltd. N/A Singapore
Name E-Mail Phone Number Postal Address
Ross Ronsayro ross.ronsayro@boehringer-ingelheim.com +632 8670965 Boehringer Ingelheim Phil. Inc. 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City 1227
Name E-Mail Phone Number Postal Address
Ross Ronsayro ross.ronsayro@boehringer-ingelheim.com +632 8670965 Boehringer Ingelheim Phil. Inc. 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City 1227
Name Expertise Affiliation
Joven Roque V. Gonong, MD Pulmonologist Lung Center of the Philippines
Val O. Custodio, MD Pulmonologist FEU - Dr. Nicanor Reyes Medical Foundation
Project Location Institutional Ethics Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee
FEU - Dr. Nicanor Reyes Medical Foundation N/A

Asthma

Primary endpoint: peak FEV1 response within 3 hours post dosing (FEV1 peak0-3h response) after 12 weeks of treatment.

Secondary endpoints: trough FEV1 (key secondary endpoint); peak FVC within 3 hours post dosing; FEV1 (AUC0-3h); FVC (AUC0-3h); ACQ; use of PRN rescue medication; time to first severe asthma exacerbation; time to first asthma exacerbation.

Completed

  • Philippines

Clinical Trial

Unspecified

2012-11-05

None

Inclusion criteria
1. All patients and their parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with ICH GCP guidelines and local legislation prior to the patient’s participation in the trial, i.e. prior to any study procedures including medication wash-out and restrictions. A separate informed consent/assent is required for pharmacogenomic sampling (consent/assent for pharmacogenomic sampling is not a prerequisite for study entry).
2. Male or female patients between 12 and 17 years of age (at date of informed consent/assent).
3. All patients must have at least a 3-month history of asthma at the time of enrolment into the trial.
4. All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication (e.g. a LABA or a leukotriene modifier), OR at stable medium dose in combination with two other controller medications (e.g. a LABA and/or a leukotriene modifier and/or a
sustained release theophylline), for at least 4 weeks before Visit 1. For the lower age group (i.e. 12 to 14 year old patients) the inhaled corticosteroid dosing recommendations for “children older than 5
years” may be appropriate).
5. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of ≥ 1.5.

NOTE: If the patient is not eligible due to the predefined score at Visit 1, the patient should not be further evaluated. If the patient is not eligible due to the predefined score at Visit 2, the patient’s Visit 2 can be repeated once for further assessment .

6. All patients must have a pre-bronchodilator FEV1 ≥ 60% and ≤ 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to Wang et al.
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% and ≥ 200 mL 15 to 30 minutes after 400 μg salbutamol (albuterol). If patients in the lower age range (e.g. 12 to 14 year old patients) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (≥12%) post-bronchodilator response.
9. All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
10. Patients should be able to use the Respimat® inhaler correctly.
11. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to ATS/ERS standards and use of the electronic diary/peak flow meter (diary compliance of at least 80% is required).

Exclusion criteria
1. Patients with a significant disease other than asthma (e.g. cystic fibrosis).
A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient’s ability to participate in the trial.
2. Patients with a clinically relevant abnormal haematology or blood chemistry at screening (Visit 1), if the abnormality defines a significant disease as defined in
exclusion criterion No. 1.
3. Patients with a history of congenital or acquired heart disease, and/or who have been hospitalised for cardiac syncope or failure during the past year.
4. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia
requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
5. Patients with 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 with significant (in the opinion of the investigator) alcohol or drug abuse within the past two years.
8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
9. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to Visit 1.
10. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the study medication delivery system.
11. Pregnant or nursing adolescent female patients, including female patients with a positive β-HCG (serum pregnancy) testing at Visit 1.
12. Female patients of child-bearing potential not using a highly effective method of birth control.

NOTE: Sexual abstinence is deemed to be a highly effective method of contraception.

As defined in ICH (M3), note 3, highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. Barrier contraceptives (e.g. male condom or diaphragm) are acceptable if used in combination with spermicides (e.g. foam gel).

13. Patients who have taken an investigational drug within four weeks or six half lives (whichever is greater) prior to Visit 1.
14. Patients who have been treated with long-acting inhaled anticholinergics (e.g. tiotropium - Spiriva®) or systemic anticholinergic treatment such as spasmolytics within four weeks prior to Visit 1 and/or during the screening period (between Visit 1 and Visit 2).
15. Patients who have been treated with systemic (oral or intravenous) corticosteroids at a high dose (prednisolone or prednisolone equivalent > 5mg/day or > 10 mg every second day) or at a not stable low dose (prednisolone or prednisolone equivalent < 5mg/day or < 10 mg every second day) within four weeks prior to Visit 1 and/or during the screening period (between Visit 1 and Visit 2).
16. Patients who have been treated with leukotriene modifiers if not stabilised for at least
four weeks prior to Visit 1 or during the screening period (between Visit 1 and Visit 2).
17. Patients who have been treated with long-acting theophylline preparations if not stabilised for at least two weeks prior to Visit 1 or during the screening period (between Visit 1 and Visit 2).
18. Patients who have been treated with anti-IgE treatment (e.g. omalizumab - Xolair®) if not stabilised for at least six months prior to Visit 1 or during the screening period (between Visit 1 and Visit 2).
19. Patients who have been treated with cromones (e.g. sodium cromoglycate and nedocromil sodium) if not stabilised within four weeks prior to Visit 1 and/or during the screening period (between Visit 1 and Visit 2).
20. Patients who have been treated with oral beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period (between Visit 1 and Visit 2). Topical cardio-selective beta-blocker eye medications for treatment of non-arrow angle glaucoma are allowed.
21. Patients who have been treated with systemic oral or i.v. beta-adrenergics within four weeks prior to Visit 1 and/or during the screening period (between Visit 1 and Visit 2).
22. Patients who have been treated with other non-approved and according to international guidelines not recommended ‘experimental’ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporine) within four weeks prior to Visit 1 or during the screening period (between Visit 1 and Visit 2).
23. Patients with any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1. In case of an asthma deterioration occurring during the screening period (period between Visit 1 to Visit 2), Visit 2 should be postponed.
Refer to Section 6.1 for information on re-scheduling of visits.
24. Patients who have previously been randomised in this trial or are currently participating in another trial.
25. Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated (in the opinion of the investigator).
26. Patients with moderate to severe renal impairment, as defined by a creatinine clearance excreted drug. Creatinine clearance will be calculated according to Schwartz Formula.
27. Patients requiring 10 or more puffs of rescue medication (salbutamol/albuterol MDI) per day on more than 2 consecutive days during the screening period.

 

Interventional

tiotropium inhalation solution

tiotropium inhalation solution delivered via inhaler (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma

Randomized

Double Blind

A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 μg and 5 μg once daily) over 12 weeks as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma

Parallel

Evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 μg and 5 μg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

Phase III

8

6

one site only recruited 1 patient prior to close of ennrollment.

13 Apr 2012

Utilization Utilization Info
No records found.

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