AzTrials
AzTrials

AsthmaPhase 3NCT01172808

Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I

A Phase 3 study testing tiotropium Respimat® low dose, tiotropium Respimat® high dose and 50 mcg salmeterol HFA MDI in people with Asthma, run by Boehringer Ingelheim at 114 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
tiotropium Respimat® low dose, tiotropium Respimat® high dose and 50 mcg salmeterol HFA MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,071 participants
Where
114 sitesin 11 countries
Study dates
Aug 2010to Nov 2012
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
  • Male or female patients aged at least 18 years but not more than 75 years.
  • All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5.
  • The initial diagnosis of asthma must have been made before the patient's age of 40.
  • The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 minutes after 400 mcg salbutamol (albuterol)) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200mL.
  • All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids for at least for 4 weeks prior to Visit 1.
Show all 12Show fewer
  • All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5.
  • All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.
  • Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
  • Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years.
  • Patients must be able to use the Respimat® inhaler and metered dose 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.

Who cannot join

  • Patients with a significant disease other than asthma. 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.
  • Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1.
  • Patients with a recent history (i.e. six months or less) of myocardial infarction.
  • Patients who have been hospitalised for cardiac 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 lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
Show all 25Show fewer
  • Patients with known active tuberculosis.
  • Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
  • 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.
  • Patients with significant alcohol or drug abuse within the past two years.
  • Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
  • Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediamineteraacetic acid (EDTA), salmeterol xinafoate or any other components of the study medication delivery systems.
  • Pregnant or nursing woman.
  • Women of childbearing potential not using a highly effective method of birth control.
  • Patients who have taken an investigational drug within four weeks prior to Visit 1.
  • Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed.
  • Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period.
  • Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
  • Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
  • Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period.
  • Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period.
  • Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
  • Patients who have been treated with other 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 with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period.
  • Patients who have previously been randomised in this trial or in the respective twin trial (205.419) or are currently participating in another trial.

Trial locations and contacts

114 sites in 11 countries.

114 sites in 11 countries

Japan30 sites

  • 205.418.81018 Boehringer Ingelheim Investigational Site

    Adachi-ku, Tokyo

  • 205.418.81030 Boehringer Ingelheim Investigational Site

    Ako, Hyogo

  • 205.418.81001 Boehringer Ingelheim Investigational Site

    Chiyoda-ku, Tokyo

  • 205.418.81005 Boehringer Ingelheim Investigational Site

    Chuo-ku, Tokyo

  • 205.418.81025 Boehringer Ingelheim Investigational Site

    Chuo-ku, Tokyo

  • 205.418.81015 Boehringer Ingelheim Investigational Site

    Fujioka, Gunma

  • 205.418.81023 Boehringer Ingelheim Investigational Site

    Himeji, Hyogo

  • 205.418.81007 Boehringer Ingelheim Investigational Site

    Hitachi, Ibaraki

  • 205.418.81009 Boehringer Ingelheim Investigational Site

    Iwamizawa, Hokkaido

  • 205.418.81028 Boehringer Ingelheim Investigational Site

    Kanazawa, Ishikawa

  • 205.418.81011 Boehringer Ingelheim Investigational Site

    Kitakami, Iwate

  • 205.418.81012 Boehringer Ingelheim Investigational Site

    Kitakami, Iwate

  • 205.418.81031 Boehringer Ingelheim Investigational Site

    Koga, Ibaraki

  • 205.418.81016 Boehringer Ingelheim Investigational Site

    Koganei, Tokyo

  • 205.418.81006 Boehringer Ingelheim Investigational Site

    Komaki, Aichi

  • 205.418.81002 Boehringer Ingelheim Investigational Site

    Kunitachi, Tokyo

  • 205.418.81004 Boehringer Ingelheim Investigational Site

    Mito, Ibaraki

  • 205.418.81032 Boehringer Ingelheim Investigational Site

    Osaka, Osaka

  • 205.418.81019 Boehringer Ingelheim Investigational Site

    Ota-ku, Tokyo

  • 205.418.81008 Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido

  • 205.418.81013 Boehringer Ingelheim Investigational Site

    Sendai, Miyagi

  • 205.418.81014 Boehringer Ingelheim Investigational Site

    Sendai, Miyagi

  • 205.418.81026 Boehringer Ingelheim Investigational Site

    Setagaya-ku, Tokyo

  • 205.418.81024 Boehringer Ingelheim Investigational Site

    Takasaki, Gunma

  • 205.418.81010 Boehringer Ingelheim Investigational Site

    Tomakomai, Hokkaido

  • 205.418.81003 Boehringer Ingelheim Investigational Site

    Toshima-ku, Tokyo

  • 205.418.81017 Boehringer Ingelheim Investigational Site

    Toshima-ku, Tokyo

  • 205.418.81022 Boehringer Ingelheim Investigational Site

    Yao, Osaka

  • 205.418.81020 Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa

  • 205.418.81021 Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa

Other trials in Japan

United States21 sites

  • 205.418.01012 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 205.418.01006 Boehringer Ingelheim Investigational Site

    Bellevue, Nebraska

  • 205.418.01016 Boehringer Ingelheim Investigational Site

    Boys Town, Nebraska

  • 205.418.01005 Boehringer Ingelheim Investigational Site

    Charleston, South Carolina

  • 205.418.01004 Boehringer Ingelheim Investigational Site

    Coeur d'Alene, Idaho

  • 205.418.01007 Boehringer Ingelheim Investigational Site

    Dallas, Texas

  • 205.418.01010 Boehringer Ingelheim Investigational Site

    Easely, South Carolina

  • 205.418.01020 Boehringer Ingelheim Investigational Site

    Huntington Beach, California

  • 205.418.01009 Boehringer Ingelheim Investigational Site

    Minneapolis, Minnesota

  • 205.418.01002 Boehringer Ingelheim Investigational Site

    Mission Viejo, California

  • 205.418.01017 Boehringer Ingelheim Investigational Site

    Normal, Illinois

  • 205.418.01013 Boehringer Ingelheim Investigational Site

    North Dartmouth, Massachusetts

  • 205.418.01015 Boehringer Ingelheim Investigational Site

    North Dartmouth, Massachusetts

  • 205.418.01018 Boehringer Ingelheim Investigational Site

    Oklahoma City, Oklahoma

  • 205.418.01003 Boehringer Ingelheim Investigational Site

    Omaha, Nebraska

  • 205.418.01014 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 205.418.01019 Boehringer Ingelheim Investigational Site

    Seattle, Washington

  • 205.418.01008 Boehringer Ingelheim Investigational Site

    South Bend, Indiana

  • 205.418.01001 Boehringer Ingelheim Investigational Site

    Tacoma, Washington

  • 205.418.01011 Boehringer Ingelheim Investigational Site

    Wheat Ridge, Colorado

  • 205.418.01021 Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

China15 sites

  • 205.418.86001 Boehringer Ingelheim Investigational Site

    Beijing

  • 205.418.86005 Boehringer Ingelheim Investigational Site

    Beijing

  • 205.418.86007 Boehringer Ingelheim Investigational Site

    Beijing

  • 205.418.86012 Boehringer Ingelheim Investigational Site

    Beijing

  • 205.418.86014 Boehringer Ingelheim Investigational Site

    Changsha

  • 205.418.86011 Boehringer Ingelheim Investigational Site

    Chengdu

  • 205.418.86015 Boehringer Ingelheim Investigational Site

    Chengdu

  • 205.418.86003 Boehringer Ingelheim Investigational Site

    Chongqing

  • 205.418.86010 Boehringer Ingelheim Investigational Site

    Guangzhou

  • 205.418.86013 Boehringer Ingelheim Investigational Site

    Kunming

  • 205.418.86008 Boehringer Ingelheim Investigational Site

    Qingdao

  • 205.418.86002 Boehringer Ingelheim Investigational Site

    Shanghai

  • 205.418.86004 Boehringer Ingelheim Investigational Site

    Shenyang

  • 205.418.86009 Boehringer Ingelheim Investigational Site

    Shenyang

  • 205.418.86006 Boehringer Ingelheim Investigational Site

    Xi'an

Other trials in China

India9 sites

  • 205.418.91008 Boehringer Ingelheim Investigational Site

    Banglore

  • 205.418.91005 Boehringer Ingelheim Investigational Site

    Chennai

  • 205.418.91004 Boehringer Ingelheim Investigational Site

    Coimbatore

  • 205.418.91006 Boehringer Ingelheim Investigational Site

    Coimbatore

  • 205.418.91003 Boehringer Ingelheim Investigational Site

    Hyderabad

  • 205.418.91009 Boehringer Ingelheim Investigational Site

    Jaipur

  • 205.418.91002 Boehringer Ingelheim Investigational Site

    Nagpur

  • 205.418.91007 Boehringer Ingelheim Investigational Site

    Pune

  • 205.418.91010 Boehringer Ingelheim Investigational Site

    Pune

Other trials in India

Latvia9 sites

  • 205.418.37004 Boehringer Ingelheim Investigational Site

    Daugavpils

  • 205.418.37008 Boehringer Ingelheim Investigational Site

    Preiļi

  • 205.418.37001 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37002 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37005 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37006 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37007 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37009 Boehringer Ingelheim Investigational Site

    Riga

  • 205.418.37003 Boehringer Ingelheim Investigational Site

    Ventspils

Other trials in Latvia

Russia8 sites

  • 205.418.07007 Boehringer Ingelheim Investigational Site

    Gatchina (Leningradskaya Oblast)

  • 205.418.07004 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.418.07005 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.418.07006 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.418.07008 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.418.07001 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.418.07002 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.418.07003 Boehringer Ingelheim Investigational Site

    Saint Petersburg

Other trials in Russia

Poland6 sites

  • 205.418.48006 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.418.48001 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.418.48005 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.418.48002 Boehringer Ingelheim Investigational Site

    Ostrow Wielkopolska

  • 205.418.48004 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.418.48003 Boehringer Ingelheim Investigational Site

    Tczew

Other trials in Poland

Brazil5 sites

  • 205.418.55002 Boehringer Ingelheim Investigational Site

    Juiz de Fora

  • 205.418.55001 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 205.418.55004 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 205.418.55005 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 205.418.55003 Boehringer Ingelheim Investigational Site

    Rio de Janeiro - RJ

Other trials in Brazil

Guatemala5 sites

  • 205.418.50203 Boehringer Ingelheim Investigational Site

    Guatelama City

  • 205.418.50204 Boehringer Ingelheim Investigational Site

    Guatelmala City

  • 205.418.50205 Boehringer Ingelheim Investigational Site

    Guatelmala City

  • 205.418.50201 Boehringer Ingelheim Investigational Site

    Guatemala City

  • 205.418.50202 Boehringer Ingelheim Investigational Site

    Guatemala City

Other trials in Guatemala

Mexico3 sites

  • 205.418.52002 Boehringer Ingelheim Investigational Site

    Monterrey

  • 205.418.52003 Boehringer Ingelheim Investigational Site

    Zapopan

  • 205.418.52001 Boehringer Ingelheim Investigational Site

    Zona Río

Other trials in Mexico

Peru3 sites

  • 205.418.51003 Boehringer Ingelheim Investigational Site

    Callao

  • 205.418.51001 Boehringer Ingelheim Investigational Site

    Lima

  • 205.418.51002 Boehringer Ingelheim Investigational Site

    Lima

Other trials in Peru

About this study

Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Conditions
Asthma
Being tested
Placebo, tiotropium Respimat® low dose, tiotropium Respimat® high dose, 50 mcg salmeterol HFA MDI
Medical subject headings
Asthma

What participants receive

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

  • PlaceboDrug

    Placebo that represents comparator

  • tiotropium Respimat® low doseDrug

    IMP

  • PlaceboDrug

    Placebo that represents comparator

  • PlaceboDrug

    Placebo that represents comparator

  • tiotropium Respimat® high doseDrug

    IMP

  • 50 mcg salmeterol HFA MDIDrug

    Active comparator

  • PlaceboDrug

    Placebo that represents BI drug

  • PlaceboDrug

    Placebo that represents BI drug

Study groups in NCT01172808
Study groupRoleWhat they receive
tiotropium low doseExperimentalOnce daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
Receives: Drug: Placebo; Drug: tiotropium Respimat® low dose
tiotropium high doseExperimentalOnce daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
Receives: Drug: Placebo; Drug: tiotropium Respimat® high dose
50 mcg salmeterolActive comparatorTwice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
Receives: Drug: 50 mcg salmeterol HFA MDI; Drug: Placebo
placeboPlacebo comparatorOnce daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
Receives: Drug: Placebo

What is being measured

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

  1. Peak FEV1 Within 3 Hours Post-dose Response

    Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  2. Trough FEV1 Response

    Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  3. The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)

    The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.

    The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).

    Measured: 24 weeks

Secondary outcomes (17)

  1. Peak FVC Within 3 Hours Post-dose Response

    Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  2. Trough FVC Response

    Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  3. FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response

    Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

    Measured: 24 weeks

  4. FVC Area Under Curve 0-3 Hours (AUC0-3h) Response

    Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.

    Measured: 24 weeks

  5. Trough PEF Response

    Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  6. Total Asthma Quality of Life Questionnaire (AQLQs)) Score

    Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  7. Total Asthma Control Questionnaire (ACQ) Score at the End of the 24-week Treatment Period

    Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: 24 weeks

  8. The Responder Rate as Assessed by the ACQ

    The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).

    Measured: 24 weeks

  9. Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24

    Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: Baseline and last 7 days before week 24 visit

  10. Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24

    Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: Baseline and last 7 days before week 24 visit

  11. PEF Variability

    PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.

    Measured: Last 7 days before week 24 visit

  12. Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24

    Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: Baseline and last 7 days before week 24 visit

  13. Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24

    Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: Baseline and last 7 days before week 24 visit

  14. Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24

    Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.

    Measured: Baseline and last 7 days before week 24 visit

  15. Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24

    Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.

    Measured: Baseline and last 7 days before week 24 visit

  16. Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)

    Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).

    Measured: 24 weeks

  17. Time to First Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)

    Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)

    Measured: 24 weeks

Timeline

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

  1. First posted30 Jul 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
1,071 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01172808
Sponsor's protocol ID
205.418
Other IDs
2009-018004-18, 2009
Status last verified
Jan 2014
First submitted
26 Jul 2010
Last updated
9 Jun 2014

Publications

  • Halpin DMG, Hamelmann EH, Frith PA, Moroni-Zentgraf PM, van Hecke B, Unseld A, Kerstjens HAM, Szefler SJ. Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis. Pulm Ther. 2020 Jun;6(1):131-140. doi: 10.1007/s41030-020-00113-w. Epub 2020 Mar 16.

    PubMed 32180164

  • Casale TB, Aalbers R, Bleecker ER, Meltzer EO, Zaremba-Pechmann L, de la Hoz A, Kerstjens HAM. Tiotropium Respimat(R) add-on therapy to inhaled corticosteroids in patients with symptomatic asthma improves clinical outcomes regardless of baseline characteristics. Respir Med. 2019 Oct-Nov;158:97-109. doi: 10.1016/j.rmed.2019.09.014. Epub 2019 Sep 30.

    PubMed 31654891

  • Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6.

    PubMed 31319851

  • Casale TB, Bateman ED, Vandewalker M, Virchow JC, Schmidt H, Engel M, Moroni-Zentgraf P, Kerstjens HAM. Tiotropium Respimat Add-on Is Efficacious in Symptomatic Asthma, Independent of T2 Phenotype. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):923-935.e9. doi: 10.1016/j.jaip.2017.08.037. Epub 2017 Nov 22.

    PubMed 29174062

  • Kerstjens HA, Casale TB, Bleecker ER, Meltzer EO, Pizzichini E, Schmidt O, Engel M, Bour L, Verkleij CB, Moroni-Zentgraf P, Bateman ED. Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials. Lancet Respir Med. 2015 May;3(5):367-76. doi: 10.1016/S2213-2600(15)00031-4. Epub 2015 Feb 12.

    PubMed 25682232

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tiotropium Respimat® low dose, tiotropium Respimat® high dose and 50 mcg salmeterol HFA MDI in people with Asthma, run by Boehringer Ingelheim at 114 sites in 11 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 12 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Japan, United States, China, India, Latvia and 6 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 7 Feb 2014). 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?

Peak FEV1 Within 3 Hours Post-dose Response (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 NCT01172808, which also lists 5 linked publications.

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 9 Jun 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in