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

June 3, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1032

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Florianopolis, Brazil
        • 205.419.55053 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 205.419.55054 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 205.419.55052 Boehringer Ingelheim Investigational Site
      • Sao Paulo, Brazil
        • 205.419.55055 Boehringer Ingelheim Investigational Site
  • China
      • Chengdu, China
        • 205.419.86061 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 205.419.86053 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 205.419.86056 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 205.419.86062 Boehringer Ingelheim Investigational Site
      • Haikou, China
        • 205.419.86054 Boehringer Ingelheim Investigational Site
      • Kunming, China
        • 205.419.86059 Boehringer Ingelheim Investigational Site
      • Nanchang, China
        • 205.419.86058 Boehringer Ingelheim Investigational Site
      • Nanjing, China
        • 205.419.86064 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.419.86051 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.419.86052 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.419.86055 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 205.419.86066 Boehringer Ingelheim Investigational Site
      • Xi'An, China
        • 205.419.86057 Boehringer Ingelheim Investigational Site
      • Xi'An, China
        • 205.419.86065 Boehringer Ingelheim Investigational Site
      • Xuzhou, China
        • 205.419.86063 Boehringer Ingelheim Investigational Site
      • Yangzhou, China
        • 205.419.86067 Boehringer Ingelheim Investigational Site
      • Yinchuan, China
        • 205.419.86068 Boehringer Ingelheim Investigational Site
  • Colombia
      • Bogota, Colombia
        • 205.419.57051 Boehringer Ingelheim Investigational Site
      • Bogota, Colombia
        • 205.419.57052 Boehringer Ingelheim Investigational Site
      • Bogota, Colombia
        • 205.419.57053 Boehringer Ingelheim Investigational Site
      • Medelin, Colombia
        • 205.419.57054 Boehringer Ingelheim Investigational Site
  • Germany
      • Bamberg, Germany
        • 205.419.49061 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.419.49051 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.419.49052 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.419.49062 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.419.49063 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 205.419.49064 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 205.419.49054 Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • 205.419.49058 Boehringer Ingelheim Investigational Site
      • Koblenz, Germany
        • 205.419.49057 Boehringer Ingelheim Investigational Site
      • Lübeck, Germany
        • 205.419.49056 Boehringer Ingelheim Investigational Site
      • Rüdersdorf, Germany
        • 205.419.49059 Boehringer Ingelheim Investigational Site
      • Wiesbaden, Germany
        • 205.419.49053 Boehringer Ingelheim Investigational Site
      • Witten, Germany
        • 205.419.49055 Boehringer Ingelheim Investigational Site
  • India
      • Ahmedabad, India
        • 205.419.91057 Boehringer Ingelheim Investigational Site
      • Coimbatore, India
        • 205.419.91056 Boehringer Ingelheim Investigational Site
      • Hyderabad, India
        • 205.419.91055 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 205.419.91051 Boehringer Ingelheim Investigational Site
      • Jaipur, India
        • 205.419.91058 Boehringer Ingelheim Investigational Site
      • Mumbai, India
        • 205.419.91054 Boehringer Ingelheim Investigational Site
      • Mysore, India
        • 205.419.91059 Boehringer Ingelheim Investigational Site
      • Nagpur, India
        • 205.419.91053 Boehringer Ingelheim Investigational Site
  • Japan
      • Aira, Kagoshima, Japan
        • 205.419.81085 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 205.419.81062 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 205.419.81073 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 205.419.81074 Boehringer Ingelheim Investigational Site
      • Fukuyama, Hiroshima, Japan
        • 205.419.81072 Boehringer Ingelheim Investigational Site
      • Habikino, Osaka, Japan
        • 205.419.81069 Boehringer Ingelheim Investigational Site
      • Hiroshima, Hiroshima, Japan
        • 205.419.81071 Boehringer Ingelheim Investigational Site
      • Itabashi-ku, Tokyo, Japan
        • 205.419.81058 Boehringer Ingelheim Investigational Site
      • Iwata, Shizuoka, Japan
        • 205.419.81064 Boehringer Ingelheim Investigational Site
      • Kanazawa, Ishikawa, Japan
        • 205.419.81063 Boehringer Ingelheim Investigational Site
      • Kishiwada, Osaka, Japan
        • 205.419.81054 Boehringer Ingelheim Investigational Site
      • Kitakyushu, Fukuoka, Japan
        • 205.419.81075 Boehringer Ingelheim Investigational Site
      • Kobe, Hyogo, Japan
        • 205.419.81070 Boehringer Ingelheim Investigational Site
      • Koto-ku, Tokyo, Japan
        • 205.419.81061 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japan
        • 205.419.81067 Boehringer Ingelheim Investigational Site
      • Matsusaka, Mie, Japan
        • 205.419.81080 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 205.419.81081 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo, Japan
        • 205.419.81060 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo, Japan
        • 205.419.81077 Boehringer Ingelheim Investigational Site
      • Morioka, Iwate, Japan
        • 205.419.81056 Boehringer Ingelheim Investigational Site
      • Naka-gun, Ibaraki, Japan
        • 205.419.81055 Boehringer Ingelheim Investigational Site
      • Nakano-ku,Tokyo, Japan
        • 205.419.81078 Boehringer Ingelheim Investigational Site
      • Oita,Oita, Japan
        • 205.419.81084 Boehringer Ingelheim Investigational Site
      • Osaka-Sayama, Osaka, Japan
        • 205.419.81068 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 205.419.81053 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 205.419.81057 Boehringer Ingelheim Investigational Site
      • Seto, Aichi, Japan
        • 205.419.81059 Boehringer Ingelheim Investigational Site
      • Shinagawa-ku, Tokyo, Japan
        • 205.419.81082 Boehringer Ingelheim Investigational Site
      • Shizuoka, Shizuoka, Japan
        • 205.419.81065 Boehringer Ingelheim Investigational Site
      • Toyota, Aichi, Japan
        • 205.419.81066 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 205.419.81051 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 205.419.81052 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa, Japan
        • 205.419.81076 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 205.419.81083 Boehringer Ingelheim Investigational Site
      • Yotsukaido, Chiba, Japan
        • 205.419.81079 Boehringer Ingelheim Investigational Site
  • Mexico
      • Mexico City, Mexico
        • 205.419.52051 Boehringer Ingelheim Investigational Site
      • Mexico City, Mexico
        • 205.419.52052 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 205.419.52053 Boehringer Ingelheim Investigational Site
  • Peru
      • Lima, Peru
        • 205.419.51051 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 205.419.51052 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 205.419.51053 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 205.419.51054 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 205.419.51055 Boehringer Ingelheim Investigational Site
  • Poland
      • Bialystok, Poland
        • 205.419.48052 Boehringer Ingelheim Investigational Site
      • Bydgoszcz, Poland
        • 205.419.48054 Boehringer Ingelheim Investigational Site
      • Gorzow Wielkopolski, Poland
        • 205.419.48055 Boehringer Ingelheim Investigational Site
      • Krakow, Poland
        • 205.419.48051 Boehringer Ingelheim Investigational Site
      • Poznan, Poland
        • 205.419.48057 Boehringer Ingelheim Investigational Site
      • Sopot, Poland
        • 205.419.48058 Boehringer Ingelheim Investigational Site
      • Wloszczowa, Poland
        • 205.419.48053 Boehringer Ingelheim Investigational Site
      • Wroclaw, Poland
        • 205.419.48056 Boehringer Ingelheim Investigational Site
  • Romania
      • Brasov, Romania
        • 205.419.40055 Boehringer Ingelheim Investigational Site
      • Brasov, Romania
        • 205.419.40056 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 205.419.40052 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 205.419.40053 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 205.419.40054 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 205.419.40058 Boehringer Ingelheim Investigational Site
      • Bucharest, Romania
        • 205.419.40060 Boehringer Ingelheim Investigational Site
      • Bucuresti, Romania
        • 205.419.40051 Boehringer Ingelheim Investigational Site
      • Constanta, Romania
        • 205.419.40059 Boehringer Ingelheim Investigational Site
      • Iasi, Romania
        • 205.419.40057 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • Los Angeles, California, United States
        • 205.419.01058 Boehringer Ingelheim Investigational Site
      • Stockton, California, United States
        • 205.419.01053 Boehringer Ingelheim Investigational Site
    • Colorado
      • Centennial, Colorado, United States
        • 205.419.01061 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 205.419.01066 Boehringer Ingelheim Investigational Site
    • Florida
      • Panama City, Florida, United States
        • 205.419.01064 Boehringer Ingelheim Investigational Site
      • Winter Park, Florida, United States
        • 205.419.01060 Boehringer Ingelheim Investigational Site
    • Michigan
      • Novi, Michigan, United States
        • 205.419.01068 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States
        • 205.419.01054 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, United States
        • 205.419.01062 Boehringer Ingelheim Investigational Site
    • Montana
      • Bozeman, Montana, United States
        • 205.419.01070 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Skillman, New Jersey, United States
        • 205.419.01067 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • 205.419.01071 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 205.419.01055 Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • 205.419.01065 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States
        • 205.419.01069 Boehringer Ingelheim Investigational Site
      • Union, South Carolina, United States
        • 205.419.01056 Boehringer Ingelheim Investigational Site
    • Texas
      • El Paso, Texas, United States
        • 205.419.01063 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 205.419.01051 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. 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).
  2. Male or female patients aged at least 18 years but not more than 75 years.
  3. 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.
  4. The initial diagnosis of asthma must have been made before the patient's age of 40.
  5. 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.
  6. 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.

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.

Exclusion criteria:

  1. 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.
  2. 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.
  3. Patients with a recent history (i.e. six months or less) of myocardial infarction.
  4. Patients who have been hospitalised for cardiac failure during the past year.
  5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
  6. Patients with lung diseases other than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
  7. Patients with known active tuberculosis.
  8. 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.
  9. 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.
  10. Patients with significant alcohol or drug abuse within the past two years.
  11. 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).
  12. 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.
  13. Pregnant or nursing woman.
  14. Women of childbearing potential not using a highly effective method of birth control.
  15. Patients who have taken an investigational drug within four weeks prior to Visit 1.
  16. 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.
  17. 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.
  18. Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
  19. Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
  20. 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.
  21. Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period.
  22. Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
  23. 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.
  24. Patients with any asthma exacerbation or any respiratory tract infection iin the four weeks prior to Visit 1 and/or during the screening period.
  25. Patients who have previously been randomised in this trial or in the respective twin trial (205.418) or are currently participating in another trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tiotropium low dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
Drug: tiotropium Respimat® low dose
IMP
Drug: placebo
Placebo that represents BI drug
Drug: placebo
Placebo that represents comparator
Experimental: tiotropium high dose
Once daily, delivered with Respimat® inhaler (+ inhalation of placebo HFA MDI twice daily)
Drug: tiotropium Respimat® high dose
IMP
Drug: placebo
Placebo that represents BI drug
Drug: placebo
Placebo that represents comparator
Active Comparator: 50 mcg salmeterol
Twice daily, delivered with HFA MDI (+ inhalation of placebo Respimat® inhaler once daily)
Drug: 50 mcg salmeterol HFA MDI
Active comparator
Drug: placebo
Placebo that represents BI drug
Drug: placebo
Placebo that represents comparator
Placebo Comparator: placebo
Once daily, delivered with Respimat® inhaler + twice daily delivered with HFA MDI
Drug: placebo
Placebo that represents BI drug
Drug: placebo
Placebo that represents comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak FEV1 Within 3 Hours Post-dose Response
Time Frame: 24 weeks
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.
24 weeks
Trough FEV1 Response
Time Frame: 24 weeks
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.
24 weeks
The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)
Time Frame: 24 weeks
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak FVC Within 3 Hours Post-dose Response
Time Frame: 24 weeks
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.
24 weeks
Trough FVC Response
Time Frame: 24 weeks
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.
24 weeks
Trough PEF Response
Time Frame: 24 weeks
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.
24 weeks
Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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.
Baseline and last 7 days before week 24 visit
Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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.
Baseline and last 7 days before week 24 visit
Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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.
Baseline and last 7 days before week 24 visit
Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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.
Baseline and last 7 days before week 24 visit
Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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.
Baseline and last 7 days before week 24 visit
FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response
Time Frame: 24 weeks
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.
24 weeks
FVC Area Under Curve 0-3 Hours (AUC0-3h) Response
Time Frame: 24 weeks
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.
24 weeks
Total Asthma Quality of Life Questionnaire (AQLQs)) Score
Time Frame: 24 weeks

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.
24 weeks
Total Asthma Control Questionnaire (ACQ) Score
Time Frame: 24 weeks
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.
24 weeks
The Responder Rate as Assessed by the ACQ
Time Frame: 24 weeks
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).
24 weeks
Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24
Time Frame: Baseline and last 7 days before week 24 visit
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
Baseline and last 7 days before week 24 visit
PEF Variability
Time Frame: Last 7 days before week 24 visit
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.
Last 7 days before week 24 visit
Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)
Time Frame: 24 weeks
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)
24 weeks
Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)
Time Frame: 24 weeks
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)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

July 30, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.419
  • 2009-018005-43 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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