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AsthmaPhase 3NCT01634152

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

A Phase 3 study testing Tiotropium low dose mcg and Tiotropium high dose in people with Asthma, run by Boehringer Ingelheim at 94 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall purpose of the trial is 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 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe… 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 mcg and Tiotropium high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
401 participants
Where
94 sitesin 17 countries
Study dates
Jul 2012to May 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 either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
  • 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.
Show all 10Show fewer
  • 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 hospitalised 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.
Show all 24Show fewer
  • 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 girls with a positive urine pregnancy test at Visit 1.
  • Postmenarchal girls of child-bearing potential not using a highly effective method of birth control.
  • 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 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 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 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 prior to 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

94 sites in 17 countries.

94 sites in 17 countries

Ukraine13 sites

  • 205.446.38013 Boehringer Ingelheim Investigational Site

    Chernivtsi

  • 205.446.38002 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.446.38003 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.446.38005 Boehringer Ingelheim Investigational Site

    Donetsk

  • 205.446.38012 Boehringer Ingelheim Investigational Site

    Donetsk

  • 205.446.38009 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.446.38004 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.446.38006 Boehringer Ingelheim Investigational Site

    Kryvyi Rih

  • 205.446.38001 Boehringer Ingelheim Investigational Site

    Lviv

  • 205.446.38014 Boehringer Ingelheim Investigational Site

    Odesa

  • 205.446.38010 Boehringer Ingelheim Investigational Site

    Vinnytsia

  • 205.446.38011 Boehringer Ingelheim Investigational Site

    Zaporizhya

  • 205.446.38008 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

Other trials in Ukraine

United States10 sites

  • 205.446.01012 Boehringer Ingelheim Investigational Site

    Arlington, Texas

  • 205.446.01004 Boehringer Ingelheim Investigational Site

    Charleston, South Carolina

  • 205.446.01005 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 205.446.01009 Boehringer Ingelheim Investigational Site

    Columbia, Missouri

  • 205.446.01011 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 205.446.01002 Boehringer Ingelheim Investigational Site

    North Charleston, South Carolina

  • 205.446.01003 Boehringer Ingelheim Investigational Site

    North Dartmouth, Massachusetts

  • 205.446.01010 Boehringer Ingelheim Investigational Site

    Oklahoma City, Oklahoma

  • 205.446.01014 Boehringer Ingelheim Investigational Site

    Rolling Hills Estates, California

  • 205.446.01013 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

Other trials in United States

Russia10 sites

  • 205.446.70002 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.446.70005 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.446.70007 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.446.70011 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.446.70012 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.446.70001 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.446.70003 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.446.70004 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.446.70010 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.446.70009 Boehringer Ingelheim Investigational Site

    Yaroslavl

Other trials in Russia

Germany8 sites

  • 205.446.49012 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.446.49015 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.446.49001 Boehringer Ingelheim Investigational Site

    Bochum

  • 205.446.49007 Boehringer Ingelheim Investigational Site

    Dresden

  • 205.446.49003 Boehringer Ingelheim Investigational Site

    Frankfurt

  • 205.446.49009 Boehringer Ingelheim Investigational Site

    Koblenz

  • 205.446.49014 Boehringer Ingelheim Investigational Site

    Marburg

  • 205.446.49011 Boehringer Ingelheim Investigational Site

    Mönchengladbach

Other trials in Germany

Latvia8 sites

  • 205.446.37105 Boehringer Ingelheim Investigational Site

    Baldone

  • 205.446.37104 Boehringer Ingelheim Investigational Site

    Balvi

  • 205.446.37108 Boehringer Ingelheim Investigational Site

    Daugavpils

  • 205.446.37107 Boehringer Ingelheim Investigational Site

    Jēkabpils

  • 205.446.37101 Boehringer Ingelheim Investigational Site

    Ogre

  • 205.446.37106 Boehringer Ingelheim Investigational Site

    Rēzekne

  • 205.446.37102 Boehringer Ingelheim Investigational Site

    Riga

  • 205.446.37103 Boehringer Ingelheim Investigational Site

    Riga

Other trials in Latvia

Argentina7 sites

  • 205.446.54006 Boehringer Ingelheim Investigational Site

    Buenos Aires

  • 205.446.54002 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 205.446.54003 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 205.446.54008 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 205.446.54005 Boehringer Ingelheim Investigational Site

    Mar del Plata

  • 205.446.54004 Boehringer Ingelheim Investigational Site

    Mendoza

  • 205.446.54007 Boehringer Ingelheim Investigational Site

    San Miguel de Tucumán

Other trials in Argentina

Brazil7 sites

  • 205.446.55001 Boehringer Ingelheim Investigational Site

    Curitiba

  • 205.446.55007 Boehringer Ingelheim Investigational Site

    Goiânia

  • 205.446.55006 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 205.446.55002 Boehringer Ingelheim Investigational Site

    São Paulo

  • 205.446.55003 Boehringer Ingelheim Investigational Site

    São Paulo

  • 205.446.55004 Boehringer Ingelheim Investigational Site

    São Paulo

  • 205.446.55005 Boehringer Ingelheim Investigational Site

    São Paulo

Other trials in Brazil

Czechia4 sites

  • 205.446.42005 Boehringer Ingelheim Investigational Site

    Jablonec nad Nisou

  • 205.446.42001 Boehringer Ingelheim Investigational Site

    Jihlava

  • 205.446.42002 Boehringer Ingelheim Investigational Site

    Prague

  • 205.446.42004 Boehringer Ingelheim Investigational Site

    Prague

Other trials in Czechia

Guatemala4 sites

  • 205.446.50201 Boehringer Ingelheim Investigational Site

    Guatemala City

  • 205.446.50202 Boehringer Ingelheim Investigational Site

    Guatemala City

  • 205.446.50203 Boehringer Ingelheim Investigational Site

    Guatemala City

  • 205.446.50204 Boehringer Ingelheim Investigational Site

    Guatemala City

Other trials in Guatemala

Hungary4 sites

  • 205.446.36002 Boehringer Ingelheim Investigational Site

    Ajka

  • 205.446.36001 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.446.36003 Boehringer Ingelheim Investigational Site

    Nagyatád

  • 205.446.36004 Boehringer Ingelheim Investigational Site

    Szeged

Other trials in Hungary

Lithuania4 sites

  • 205.446.37004 Boehringer Ingelheim Investigational Site

    Šiauliai

  • 205.446.37003 Boehringer Ingelheim Investigational Site

    Tauragė

  • 205.446.37002 Boehringer Ingelheim Investigational Site

    Utena

  • 205.446.37001 Boehringer Ingelheim Investigational Site

    Vilnius

Other trials in Lithuania

Poland4 sites

  • 205.446.48004 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.446.48002 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.446.48001 Boehringer Ingelheim Investigational Site

    Lublin

  • 205.446.48003 Boehringer Ingelheim Investigational Site

    Tarnów

Other trials in Poland

Belgium3 sites

  • 205.446.32004 Boehringer Ingelheim Investigational Site

    Antwerp

  • 205.446.32005 Boehringer Ingelheim Investigational Site

    Bruges

  • 205.446.32006 Boehringer Ingelheim Investigational Site

    Namur

Other trials in Belgium

Slovakia3 sites

  • 205.446.42101 Boehringer Ingelheim Investigational Site

    Košice

  • 205.446.42103 Boehringer Ingelheim Investigational Site

    Prešov

  • 205.446.42102 Boehringer Ingelheim Investigational Site

    Spišská Nová Ves

Other trials in Slovakia

Australia2 sites

  • 205.446.61003 Boehringer Ingelheim Investigational Site

    Herston, Queensland

  • 205.446.61001 Boehringer Ingelheim Investigational Site

    Perth, Western Australia

Other trials in Australia

Canada2 sites

  • 205.446.02003 Boehringer Ingelheim Investigational Site

    London, Ontario

  • 205.446.02001 Boehringer Ingelheim Investigational Site

    Sherbrooke, Quebec

Other trials in Canada

Romania1 site

  • 205.446.40002 Boehringer Ingelheim Investigational Site

    Bucharest

Other trials in Romania

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 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma

The overall purpose of the trial is 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 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

Conditions
Asthma
Being tested
Placebo, Tiotropium low dose mcg, Tiotropium high dose
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    2 actuations once daily in the evening

  • Tiotropium low dose mcgDrug

    2 actuations once daily in the evening

  • Tiotropium high doseDrug

    2 actuations once daily in the evening

Study groups in NCT01634152
Study groupRoleWhat they receive
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo
Tiotropium low dose QDExperimentalNot described
Receives: Drug: Tiotropium low dose mcg
Tiotropium medium dose QDExperimentalNot described
Receives: Drug: Tiotropium high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1 Peak(0-3h) Change From Baseline

    Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

Secondary outcomes (24)

  1. Trough FEV1 Change From Baseline

    Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  2. 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 12 weeks of treatment.

    The measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  3. Trough FVC Change From Baseline

    Change from baseline in Trough (pre-dose) FVC measured at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  4. 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 12 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.

    Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

  5. 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 12 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.

    Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

  6. FEV1 Change From Baseline at Each Individual Timepoint

    Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.

    The measured values presented are actually adjusted means.

    Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

  7. FVC Change From Baseline at Each Individual Timepoint

    FVC change from baseline at each individual timepoint.

    The measured values presented are actually adjusted means.

    Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks

  8. Control of Asthma as Assessed by ACQ-IA Total Score

    Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.

    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.

    Measured: Baseline and 12 weeks

  9. ACQ-IA Total Score Responders

    Responder categories based on the ACQ-IA total score after 12 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: 12 weeks

  10. Use of PRN 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 week 12.

    The measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  11. Use of PRN Rescue Medication During the Daytime

    Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  12. Use of PRN Rescue Medication During the Night-time

    Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.

    Measured values presented are actually adjusted means

    Measured: Baseline and 12 weeks

  13. 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 week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  14. Peak Expiratory Flow (PEF) p.m. Change From Baseline

    Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  15. Peak Expiratory Flow (PEF) Variability Change From Baseline

    Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  16. FEV1 a.m. Change From Baseline

    Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  17. FEV1 p.m. Change From Baseline

    Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

  18. Change From Baseline in Nighttime Awakenings

    Change from baseline in nighttime awakenings based on the weekly mean at week 12.

    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.

    Measured: Baseline and 12 weeks

  19. Change From Baseline in Morning Asthma Symptoms

    Change from baseline in morning asthma symptoms based on the weekly mean at week 12.

    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.

    Measured: Baseline and 12 weeks

  20. Change From Baseline in Daytime Asthma Symptoms

    Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.

    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.

    Measured: Baseline and 12 weeks

  21. Change From Baseline in Daytime Activity Limitations

    Change from baseline in daytime activity limitations based on the weekly mean at week 12.

    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.

    Measured: Baseline and 12 weeks

  22. 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 week 12.

    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.

    Measured: Baseline and 12 weeks

  23. 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 week 12.

    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.

    Measured: Baseline and 12 weeks

  24. Change From Baseline in Asthma Symptom-free Days

    Change from baseline in asthma symptom-free days based on the weekly mean at week 12.

    A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.

    Measured values presented are actually adjusted means.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

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
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01634152
Sponsor's protocol ID
205.446
Other IDs
2011-001777-43
Status last verified
Dec 2015
First submitted
3 Jul 2012
Last updated
29 Jan 2016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium low dose mcg and Tiotropium high dose in people with Asthma, run by Boehringer Ingelheim at 94 sites in 17 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 24 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Ukraine, United States, Russia, Germany, Latvia and 12 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. Some participants in this study may receive a placebo. 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 21 Dec 2015). 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 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01634152.

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 29 Jan 2016.

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