AzTrials
AzTrials

AsthmaPhase 3NCT01172821

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 II

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 125 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
1,032 participants
Where
125 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. 7. 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.
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  • 8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.
  • 9. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
  • 10. 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.
  • 11. Patients must be able to use the Respimat® inhaler and metered dose inhaler correctly.
  • 12. 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)).
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  • 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 (205.418) or are currently participating in another trial.

Trial locations and contacts

125 sites in 11 countries.

125 sites in 11 countries

Japan35 sites

  • 205.419.81085 Boehringer Ingelheim Investigational Site

    Aira, Kagoshima

  • 205.419.81062 Boehringer Ingelheim Investigational Site

    Chuo-ku, Tokyo

  • 205.419.81073 Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka

  • 205.419.81074 Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka

  • 205.419.81072 Boehringer Ingelheim Investigational Site

    Fukuyama, Hiroshima

  • 205.419.81069 Boehringer Ingelheim Investigational Site

    Habikino, Osaka

  • 205.419.81071 Boehringer Ingelheim Investigational Site

    Hiroshima, Hiroshima

  • 205.419.81058 Boehringer Ingelheim Investigational Site

    Itabashi-ku, Tokyo

  • 205.419.81064 Boehringer Ingelheim Investigational Site

    Iwata, Shizuoka

  • 205.419.81063 Boehringer Ingelheim Investigational Site

    Kanazawa, Ishikawa

  • 205.419.81054 Boehringer Ingelheim Investigational Site

    Kishiwada, Osaka

  • 205.419.81075 Boehringer Ingelheim Investigational Site

    Kitakyushu, Fukuoka

  • 205.419.81070 Boehringer Ingelheim Investigational Site

    Kobe, Hyogo

  • 205.419.81061 Boehringer Ingelheim Investigational Site

    Koto-ku, Tokyo

  • 205.419.81067 Boehringer Ingelheim Investigational Site

    Kyoto, Kyoto

  • 205.419.81080 Boehringer Ingelheim Investigational Site

    Matsusaka, Mie

  • 205.419.81081 Boehringer Ingelheim Investigational Site

    Meguro-ku, Tokyo

  • 205.419.81060 Boehringer Ingelheim Investigational Site

    Minato-ku, Tokyo

  • 205.419.81077 Boehringer Ingelheim Investigational Site

    Minato-ku, Tokyo

  • 205.419.81056 Boehringer Ingelheim Investigational Site

    Morioka, Iwate

  • 205.419.81055 Boehringer Ingelheim Investigational Site

    Naka-gun, Ibaraki

  • 205.419.81078 Boehringer Ingelheim Investigational Site

    Nakano-ku,Tokyo

  • 205.419.81084 Boehringer Ingelheim Investigational Site

    Oita,Oita

  • 205.419.81068 Boehringer Ingelheim Investigational Site

    Osaka-Sayama, Osaka

  • 205.419.81053 Boehringer Ingelheim Investigational Site

    Sapporo, Hokkaido

  • 205.419.81057 Boehringer Ingelheim Investigational Site

    Sendai, Miyagi

  • 205.419.81059 Boehringer Ingelheim Investigational Site

    Seto, Aichi

  • 205.419.81082 Boehringer Ingelheim Investigational Site

    Shinagawa-ku, Tokyo

  • 205.419.81065 Boehringer Ingelheim Investigational Site

    Shizuoka, Shizuoka

  • 205.419.81066 Boehringer Ingelheim Investigational Site

    Toyota, Aichi

  • 205.419.81051 Boehringer Ingelheim Investigational Site

    Urasoe, Okinawa

  • 205.419.81052 Boehringer Ingelheim Investigational Site

    Urasoe, Okinawa

  • 205.419.81076 Boehringer Ingelheim Investigational Site

    Urasoe, Okinawa

  • 205.419.81083 Boehringer Ingelheim Investigational Site

    Yokohama, Kanagawa

  • 205.419.81079 Boehringer Ingelheim Investigational Site

    Yotsukaido, Chiba

Other trials in Japan

United States18 sites

  • 205.419.01070 Boehringer Ingelheim Investigational Site

    Bozeman, Montana

  • 205.419.01061 Boehringer Ingelheim Investigational Site

    Centennial, Colorado

  • 205.419.01055 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 205.419.01066 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 205.419.01063 Boehringer Ingelheim Investigational Site

    El Paso, Texas

  • 205.419.01069 Boehringer Ingelheim Investigational Site

    Greenville, South Carolina

  • 205.419.01058 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 205.419.01068 Boehringer Ingelheim Investigational Site

    Novi, Michigan

  • 205.419.01064 Boehringer Ingelheim Investigational Site

    Panama City, Florida

  • 205.419.01054 Boehringer Ingelheim Investigational Site

    Plymouth, Minnesota

  • 205.419.01065 Boehringer Ingelheim Investigational Site

    Portland, Oregon

  • 205.419.01071 Boehringer Ingelheim Investigational Site

    Raleigh, North Carolina

  • 205.419.01051 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • 205.419.01067 Boehringer Ingelheim Investigational Site

    Skillman, New Jersey

  • 205.419.01062 Boehringer Ingelheim Investigational Site

    St Louis, Missouri

  • 205.419.01053 Boehringer Ingelheim Investigational Site

    Stockton, California

  • 205.419.01056 Boehringer Ingelheim Investigational Site

    Union, South Carolina

  • 205.419.01060 Boehringer Ingelheim Investigational Site

    Winter Park, Florida

Other trials in United States

China17 sites

  • 205.419.86061 Boehringer Ingelheim Investigational Site

    Chengdu

  • 205.419.86053 Boehringer Ingelheim Investigational Site

    Chongqing

  • 205.419.86056 Boehringer Ingelheim Investigational Site

    Guangzhou

  • 205.419.86062 Boehringer Ingelheim Investigational Site

    Guangzhou

  • 205.419.86054 Boehringer Ingelheim Investigational Site

    Haikou

  • 205.419.86059 Boehringer Ingelheim Investigational Site

    Kunming

  • 205.419.86058 Boehringer Ingelheim Investigational Site

    Nanchang

  • 205.419.86064 Boehringer Ingelheim Investigational Site

    Nanjing

  • 205.419.86051 Boehringer Ingelheim Investigational Site

    Shanghai

  • 205.419.86052 Boehringer Ingelheim Investigational Site

    Shanghai

  • 205.419.86055 Boehringer Ingelheim Investigational Site

    Shanghai

  • 205.419.86066 Boehringer Ingelheim Investigational Site

    Shanghai

  • 205.419.86057 Boehringer Ingelheim Investigational Site

    Xi'an

  • 205.419.86065 Boehringer Ingelheim Investigational Site

    Xi'an

  • 205.419.86063 Boehringer Ingelheim Investigational Site

    Xuzhou

  • 205.419.86067 Boehringer Ingelheim Investigational Site

    Yangzhou

  • 205.419.86068 Boehringer Ingelheim Investigational Site

    Yinchuan

Other trials in China

Germany13 sites

  • 205.419.49061 Boehringer Ingelheim Investigational Site

    Bamberg

  • 205.419.49051 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.419.49052 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.419.49062 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.419.49063 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.419.49064 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.419.49054 Boehringer Ingelheim Investigational Site

    Frankfurt

  • 205.419.49058 Boehringer Ingelheim Investigational Site

    Hamburg

  • 205.419.49057 Boehringer Ingelheim Investigational Site

    Koblenz

  • 205.419.49056 Boehringer Ingelheim Investigational Site

    Lübeck

  • 205.419.49059 Boehringer Ingelheim Investigational Site

    Rüdersdorf

  • 205.419.49053 Boehringer Ingelheim Investigational Site

    Wiesbaden

  • 205.419.49055 Boehringer Ingelheim Investigational Site

    Witten

Other trials in Germany

Romania10 sites

  • 205.419.40055 Boehringer Ingelheim Investigational Site

    Brasov

  • 205.419.40056 Boehringer Ingelheim Investigational Site

    Brasov

  • 205.419.40051 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40052 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40053 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40054 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40058 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40060 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.419.40059 Boehringer Ingelheim Investigational Site

    Constanța

  • 205.419.40057 Boehringer Ingelheim Investigational Site

    Iași

Other trials in Romania

India8 sites

  • 205.419.91057 Boehringer Ingelheim Investigational Site

    Ahmedabad

  • 205.419.91056 Boehringer Ingelheim Investigational Site

    Coimbatore

  • 205.419.91055 Boehringer Ingelheim Investigational Site

    Hyderabad

  • 205.419.91051 Boehringer Ingelheim Investigational Site

    Jaipur

  • 205.419.91058 Boehringer Ingelheim Investigational Site

    Jaipur

  • 205.419.91054 Boehringer Ingelheim Investigational Site

    Mumbai

  • 205.419.91059 Boehringer Ingelheim Investigational Site

    Mysore

  • 205.419.91053 Boehringer Ingelheim Investigational Site

    Nagpur

Other trials in India

Poland8 sites

  • 205.419.48052 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.419.48054 Boehringer Ingelheim Investigational Site

    Bydgoszcz

  • 205.419.48055 Boehringer Ingelheim Investigational Site

    Gorzów Wielkopolski

  • 205.419.48051 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.419.48057 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.419.48058 Boehringer Ingelheim Investigational Site

    Sopot

  • 205.419.48053 Boehringer Ingelheim Investigational Site

    Włoszczowa

  • 205.419.48056 Boehringer Ingelheim Investigational Site

    Wroclaw

Other trials in Poland

Peru5 sites

  • 205.419.51051 Boehringer Ingelheim Investigational Site

    Lima

  • 205.419.51052 Boehringer Ingelheim Investigational Site

    Lima

  • 205.419.51053 Boehringer Ingelheim Investigational Site

    Lima

  • 205.419.51054 Boehringer Ingelheim Investigational Site

    Lima

  • 205.419.51055 Boehringer Ingelheim Investigational Site

    Lima

Other trials in Peru

Brazil4 sites

  • 205.419.55053 Boehringer Ingelheim Investigational Site

    Florianópolis

  • 205.419.55054 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 205.419.55052 Boehringer Ingelheim Investigational Site

    São Paulo

  • 205.419.55055 Boehringer Ingelheim Investigational Site

    São Paulo

Other trials in Brazil

Colombia4 sites

  • 205.419.57051 Boehringer Ingelheim Investigational Site

    Bogotá

  • 205.419.57052 Boehringer Ingelheim Investigational Site

    Bogotá

  • 205.419.57053 Boehringer Ingelheim Investigational Site

    Bogotá

  • 205.419.57054 Boehringer Ingelheim Investigational Site

    Medellín

Other trials in Colombia

Mexico3 sites

  • 205.419.52051 Boehringer Ingelheim Investigational Site

    Mexico City

  • 205.419.52052 Boehringer Ingelheim Investigational Site

    Mexico City

  • 205.419.52053 Boehringer Ingelheim Investigational Site

    Monterrey

Other trials in Mexico

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 BI drug

  • placeboDrug

    Placebo that represents comparator

  • placeboDrug

    Placebo that represents comparator

  • tiotropium Respimat® low doseDrug

    IMP

  • placeboDrug

    Placebo that represents BI drug

  • tiotropium Respimat® high doseDrug

    IMP

  • 50 mcg salmeterol HFA MDIDrug

    Active comparator

  • placeboDrug

    Placebo that represents comparator

Study groups in NCT01172821
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: tiotropium Respimat® high dose; Drug: placebo
50 mcg salmeterolActive comparatorTwice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
Receives: Drug: placebo; Drug: 50 mcg salmeterol HFA MDI
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 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

    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.

    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 and ranges from from 1 (highest intensity) till 7 (no symptoms). 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

    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 and ranges from from 0 (no symptoms) till 6 (highest intensity). 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 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, country, 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 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

    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 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)

    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
1,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01172821
Sponsor's protocol ID
205.419
Other IDs
2009-018005-43, 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 125 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 11 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 125 sites in Japan, United States, China, Germany, Romania 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 NCT01172821, 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.

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