AsthmaPhase 3NCT01634139
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent Asthma
A Phase 3 study testing Tiotropium low dose QD and Tiotropium high dose QD in people with Asthma, run by Boehringer Ingelheim at 79 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tiotropium low dose QD and Tiotropium high dose QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 403 participants
- Where
- 79 sitesin 16 countries
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- Patients who have previously been randomised in this trial or are currently participating in another trial.
- 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.
- 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.
- Patients who are unable to comply with medication restrictions prior to Visit 1 and or Visit 2.
- Patients with a 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.
Trial locations and contacts
79 sites in 16 countries.
79 sites in 16 countries
Ukraine13 sites
205.445.38017 Boehringer Ingelheim Investigational Site
Chernivtsi
205.445.38003 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
205.445.38005 Boehringer Ingelheim Investigational Site
Donetsk
205.445.38011 Boehringer Ingelheim Investigational Site
Donetsk
205.445.38008 Boehringer Ingelheim Investigational Site
Kharkiv
205.445.38004 Boehringer Ingelheim Investigational Site
Kiev
205.445.38012 Boehringer Ingelheim Investigational Site
Kryvyi Rih
205.445.38001 Boehringer Ingelheim Investigational Site
Lviv
205.445.38009 Boehringer Ingelheim Investigational Site
Lviv
205.445.38016 Boehringer Ingelheim Investigational Site
Odesa
205.445.38006 Boehringer Ingelheim Investigational Site
Vinnytsia
205.445.38010 Boehringer Ingelheim Investigational Site
Zaporizhya
205.445.38002 Boehringer Ingelheim Investigational Site
Zaporizhzhya
Russia9 sites
205.445.70002 Boehringer Ingelheim Investigational Site
Moscow
205.445.70005 Boehringer Ingelheim Investigational Site
Moscow
205.445.70008 Boehringer Ingelheim Investigational Site
Moscow
205.445.70011 Boehringer Ingelheim Investigational Site
Moscow
205.445.70001 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.445.70003 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.445.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.445.70009 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.445.70010 Boehringer Ingelheim Investigational Site
Yaroslavl
Latvia8 sites
205.445.37104 Boehringer Ingelheim Investigational Site
Adazi
205.445.37101 Boehringer Ingelheim Investigational Site
Baldone
205.445.37106 Boehringer Ingelheim Investigational Site
Balvi
205.445.37108 Boehringer Ingelheim Investigational Site
Daugavpils
205.445.37102 Boehringer Ingelheim Investigational Site
Ogre
205.445.37107 Boehringer Ingelheim Investigational Site
Rēzekne
205.445.37103 Boehringer Ingelheim Investigational Site
Riga
205.445.37105 Boehringer Ingelheim Investigational Site
Riga
Germany7 sites
205.445.49012 Boehringer Ingelheim Investigational Site
Berlin
205.445.49015 Boehringer Ingelheim Investigational Site
Berlin
205.445.49001 Boehringer Ingelheim Investigational Site
Bochum
205.445.49007 Boehringer Ingelheim Investigational Site
Dresden
205.445.49004 Boehringer Ingelheim Investigational Site
Ettenheim
205.445.49009 Boehringer Ingelheim Investigational Site
Koblenz
205.445.49014 Boehringer Ingelheim Investigational Site
Marburg
Portugal7 sites
205.445.35108 Boehringer Ingelheim Investigational Site
Amadora
205.445.35106 Boehringer Ingelheim Investigational Site
Aveiro
205.445.35101 Boehringer Ingelheim Investigational Site
Lisbon
205.445.35102 Boehringer Ingelheim Investigational Site
Lisbon
205.445.35107 Boehringer Ingelheim Investigational Site
Lisbon
205.445.35103 Boehringer Ingelheim Investigational Site
Porto
205.445.35105 Boehringer Ingelheim Investigational Site
Porto
United States6 sites
205.445.01012 Boehringer Ingelheim Investigational Site
Arlington, Texas
205.445.01006 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.445.01001 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.445.01002 Boehringer Ingelheim Investigational Site
Columbia, Missouri
205.445.01004 Boehringer Ingelheim Investigational Site
El Paso, Texas
205.445.01010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
Bulgaria5 sites
205.445.35901 Boehringer Ingelheim Investigational Site
Sofia
205.445.35902 Boehringer Ingelheim Investigational Site
Sofia
205.445.35903 Boehringer Ingelheim Investigational Site
Sofia
205.445.35904 Boehringer Ingelheim Investigational Site
Sofia
205.445.35905 Boehringer Ingelheim Investigational Site
Sofia
Guatemala5 sites
205.445.50201 Boehringer Ingelheim Investigational Site
Guatemala City
205.445.50202 Boehringer Ingelheim Investigational Site
Guatemala City
205.445.50203 Boehringer Ingelheim Investigational Site
Guatemala City
205.445.50204 Boehringer Ingelheim Investigational Site
Guatemala City
205.445.50205 Boehringer Ingelheim Investigational Site
Guatemala City
South Korea5 sites
205.445.82003 Boehringer Ingelheim Investigational Site
Guri-si
205.445.82002 Boehringer Ingelheim Investigational Site
Incheon
205.445.82001 Boehringer Ingelheim Investigational Site
Seoul
205.445.82005 Boehringer Ingelheim Investigational Site
Seoul
205.445.82006 Boehringer Ingelheim Investigational Site
Sungnam
Hungary3 sites
205.445.36003 Boehringer Ingelheim Investigational Site
Ajka
205.445.36001 Boehringer Ingelheim Investigational Site
Budapest
205.445.36002 Boehringer Ingelheim Investigational Site
Dombóvár
Lithuania3 sites
205.445.37002 Boehringer Ingelheim Investigational Site
Šiauliai
205.445.37005 Boehringer Ingelheim Investigational Site
Utena
205.445.37003 Boehringer Ingelheim Investigational Site
Vilnius
Romania3 sites
205.445.40001 Boehringer Ingelheim Investigational Site
Bucharest
205.445.40004 Boehringer Ingelheim Investigational Site
Bucharest
205.445.40003 Boehringer Ingelheim Investigational Site
Cluj-Napoca
Canada2 sites
205.445.02003 Boehringer Ingelheim Investigational Site
London, Ontario
205.445.02001 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
United Kingdom1 site
205.445.44001 Boehringer Ingelheim Investigational Site
London
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma
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
- Being tested
- Tiotropium low dose QD, Tiotropium high dose QD, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium low dose QDDrug
2 actuations once daily in the evening
Tiotropium high dose QDDrug
2 actuations once daily in the evening
PlaceboDrug
2 actuations once daily in the evening
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium high dose QD | Experimental | Not described Receives: Drug: Tiotropium high dose QD |
| Tiotropium low dose QD | Experimental | Not described Receives: Drug: Tiotropium low dose QD |
| Placebo QD | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 Weeks.
Secondary outcomes (30)
Trough FEV1 Change From Baseline
Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
FEV1 Peak (0-3h) at Week 48 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 48.
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.
Measured: Baseline and Week 48.
FEV1 AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
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.
Measured: 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
FEV1 change from baseline to week 24 at each individual timepoint.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: 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
Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Trough FVC Change From Baseline
Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48
FVC AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
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.
Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FVC Change From Baseline at Each Individual Timepoint
FVC change from baseline to week 24 at each individual timepoint.
The measured values presented are actually adjusted means
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24
Use of PRN (Pro re Nata) Rescue Medication Per Day
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Use of PRN Rescue Medication During Daytime
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Use of PRN Rescue Medication During Nighttime
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Peak Expiratory Flow (PEF) a.m. Change From Baseline
Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
PEF p.m. Change From Baseline
Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
PEF Variability Change From Baseline
Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
FEV1 a.m Change From Baseline
Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
FEV1 p.m. Change From Baseline
Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
ACQ-IA Total Score
Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.
The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Weeks 24 and 48.
ACQ-IA Responder Analysis
Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.
The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
Measured: Weeks 24 and 48
PAQLQ(S) Total Score
Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.
The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Weeks 24 and 48.
PAQLQ(S) Symptom Domain Score
PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Weeks 24 and 48.
PAQLQ(S) Activity Limitation Domain Score
PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Weeks 24 and 48.
PAQLQ(S) Emotional Function Domain Score
PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.
The measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Weeks 24 and 48.
Responders in PAQLQ(S) at Weeks 24 and 48
Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.
The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control).
Measured: Weeks 24 and 48.
Change From Baseline in Nighttime Awakenings
Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.
Nighttime awakenings was assessed by the question "Did you wake up during the night due to your asthma?" from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Morning Asthma Symptoms
Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.
Morning asthma symptoms was assessed by the question "how were your asthma symptoms this morning?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Asthma Symptoms
Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.
Daytime asthma symptoms was assessed by the question "how were your asthma symptoms during the day?" from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Activity Limitations
Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.
Daytime activity limitations was assessed by the question "how limited were you in your activities today because of your asthma?" from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Experiences of Shortness of Breath
Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.
Daytime experiences of shortness of breath was assessed by the question "how much shortness of breath did you experience during the day" from the e-diary. Scores range from 1 (none) to 5 (a very great deal).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Experiences of Wheeze or Cough
Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.
Daytime experiences of wheeze or cough was assessed by the question "did you experience wheeze or cough during the day?" from the e-diary. Scores range from 1 (not at all) to 5 (all the time).
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Asthma Symptom-free Days
Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.
A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.
Measured values presented are actually adjusted means.
The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint.
Measured: Baseline and Week 24, Baseline and Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634139
- Sponsor's protocol ID
- 205.445
- Other IDs
- 2011-001758-26
- Status last verified
- Jun 2016
- First submitted
- 3 Jul 2012
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01634139
- Acronym / sponsor ID
- 205.445
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Posted 12 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium low dose QD2 actuations once daily in the evening | Drug | Tiotropium low dose QD |
| Tiotropium high dose QD2 actuations once daily in the evening | Drug | Tiotropium high dose QD |
| Placebo2 actuations once daily in the evening | Drug | Placebo QD |
Primary outcome
FEV1 Peak (0-3h) Change From Baseline
Time frame: Baseline and 24 Weeks.
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.
30 secondary outcomes
Trough FEV1 Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
FEV1 Peak (0-3h) at Week 48 Change From Baseline
Time frame: Baseline and Week 48.
FEV1 AUC (0-3h) Change From Baseline
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 24, Baseline and Week 48.
Trough FVC Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48
FVC AUC (0-3h) Change From Baseline
Time frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FVC Change From Baseline at Each Individual Timepoint
Time frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24
Use of PRN (Pro re Nata) Rescue Medication Per Day
Time frame: Baseline and Week 24, Baseline and Week 48.
Use of PRN Rescue Medication During Daytime
Time frame: Baseline and Week 24, Baseline and Week 48.
Use of PRN Rescue Medication During Nighttime
Time frame: Baseline and Week 24, Baseline and Week 48.
Peak Expiratory Flow (PEF) a.m. Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
PEF p.m. Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
PEF Variability Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
FEV1 a.m Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
FEV1 p.m. Change From Baseline
Time frame: Baseline and Week 24, Baseline and Week 48.
ACQ-IA Total Score
Time frame: Weeks 24 and 48.
ACQ-IA Responder Analysis
Time frame: Weeks 24 and 48
PAQLQ(S) Total Score
Time frame: Weeks 24 and 48.
PAQLQ(S) Symptom Domain Score
Time frame: Weeks 24 and 48.
PAQLQ(S) Activity Limitation Domain Score
Time frame: Weeks 24 and 48.
PAQLQ(S) Emotional Function Domain Score
Time frame: Weeks 24 and 48.
Responders in PAQLQ(S) at Weeks 24 and 48
Time frame: Weeks 24 and 48.
Change From Baseline in Nighttime Awakenings
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Morning Asthma Symptoms
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Asthma Symptoms
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Activity Limitations
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Experiences of Shortness of Breath
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Daytime Experiences of Wheeze or Cough
Time frame: Baseline and Week 24, Baseline and Week 48.
Change From Baseline in Asthma Symptom-free Days
Time frame: Baseline and Week 24, Baseline and Week 48.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
79 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium low dose QD and Tiotropium high dose QD in people with Asthma, run by Boehringer Ingelheim at 79 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Ukraine, Russia, Latvia, Germany, Portugal and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 Peak (0-3h) Change From Baseline (time frame: Baseline and 24 Weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.