A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01013753
First received: November 13, 2009
Last updated: June 17, 2014
Last verified: May 2014
  Purpose

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.


Condition Intervention Phase
Asthma
Drug: Placebo
Drug: Olodaterol (BI 1744) high
Drug: Olodaterol (BI 1744) medium
Drug: Olodaterol (BI 1744) very low
Drug: Formoterol 12 mcg
Drug: Olodaterol (BI 1744) low
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo- and Active-Controlled, Incomplete Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Once Daily Treatment of 4 Doses of BI 1744 CL Inhalation Solution Delivered by the Respimat® in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.


Secondary Outcome Measures:
  • FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  • FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  • Peak FEV1 Within 24 Hours Post-dose Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Trough FEV1 Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.

  • Peak FVC Within 24 Hours Post-dose Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Trough FVC Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

  • PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

  • Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.

  • Peak PEF Within 24 Hours Post-dose Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Trough PEF Response [ Time Frame: 1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks ] [ Designated as safety issue: No ]
    Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.

  • Mean Pre-dose Morning PEF (PEF a.m.) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.

  • Mean Pre-dose Evening PEF (PEF p.m.) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.

  • PEF Daily Variability [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.

  • Mean Pre-dose Morning FEV1 (FEV1 a.m.) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.

  • Mean Pre-dose Evening FEV1 (FEV1 p.m.) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.

  • Mean Number of Puffs of Rescue Medication During the Whole Day [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.

  • Percentage of Asthma Symptom Free Days [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.

  • Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.

  • Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.

  • Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.

  • Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. 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.

  • Total Asthma Control Questionnaire (ACQ) Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.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.

  • Potassium 1 Hour Pre-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.

  • Potassium 1 Hour Post-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.

  • Potassium 3 Hours Post-dose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.


Enrollment: 198
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI 1744) low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) low
Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) very low
Very low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) very low
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) medium
Medium dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) medium
Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Experimental: Olodaterol (BI 1744) high
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744) high
Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat
Active Comparator: Formoterol 12 mcg
12mcg inhaled twice daily from the Aerolizer inhaler
Drug: Formoterol 12 mcg
Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Drug: Placebo
Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients must sign an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, i.e. prior to any study procedures which includes medication washout and restrictions. A separate informed consent is required for pharmacogenomic sampling.
  2. Male or female patients, aged between 18 and 70 years of age, diurnally active
  3. A history of asthma diagnosed by physician at least 3 months prior to Visit 1 at GINA treatment steps 3 or 4. The diagnosis of asthma must have been made before the age of 40.
  4. Pre-bronchodilator FEV1 between 60% predicted and 90% predicted at Visit 1.
  5. Increase in FEV1 greater or equal to 12% and 200 ml 15 minutes after 400mcg salbutamol (albuterol) at Visit 1.
  6. Patient must have been taking inhaled corticosteroids (ICS) for at least 12 weeks prior to screening, and must have been receiving at a stable dose for at least 6 weeks prior to screening either: - a medium to high dose ICS or - a low to high dose ICS in combination with Long acting beta agonist (LABA).
  7. All patients must be symptomatic.

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 study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
  2. Patients who have been hospitalised for an asthma exacerbation within 3 months or had an admission to an intensive care unit for asthma within 3 years of Visit 1
  3. Patients will be excluded when they have: - an aspartate aminotransferase (AST) >80 IU/L, alanine aminotransferase (ALT) >80 IU/L, bilirubin >1.5 X upper limit of normal (ULN) or creatinine >1.5 X ULN - clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis
  4. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis

    • a diagnosis of paroxysmal tachycardia (>100 beats per minute)
    • a marked baseline prolongation of QT/QTc interval at Visit 1 (e.g., repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14
    • a history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14.
  5. Patients with any of the following conditions: - a history of myocardial infarction within 1 year of screening visit (Visit 1)

    • a diagnosis of clinically relevant cardiac arrhythmia
    • a history of cor pulmonale
    • known active tuberculosis
    • a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
    • a history of life-threatening pulmonary obstruction
    • a history of chronic obstructive pulmonary disease
    • history of cystic fibrosis
    • clinically evident bronchiectasis
    • a history of significant alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013753

Locations
Austria
1222.27.43002 Boehringer Ingelheim Investigational Site
Linz, Austria
1222.27.43004 Boehringer Ingelheim Investigational Site
Schlüsslberg, Austria
1222.27.43001 Boehringer Ingelheim Investigational Site
Thalheim bei Wels, Austria
1222.27.43003 Boehringer Ingelheim Investigational Site
Wien, Austria
Germany
1222.27.49009 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.27.49011 Boehringer Ingelheim Investigational Site
Frankfurt, Germany
1222.27.49008 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.27.49002 Boehringer Ingelheim Investigational Site
Lübeck, Germany
1222.27.49007 Boehringer Ingelheim Investigational Site
Rüdersdorf, Germany
1222.27.49006 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
1222.27.49010 Boehringer Ingelheim Investigational Site
Wiesloch, Germany
Poland
1222.27.48002 Boehringer Ingelheim Investigational Site
Lodz, Poland
1222.27.48001 Boehringer Ingelheim Investigational Site
Lodz, Poland
1222.27.48003 Boehringer Ingelheim Investigational Site
Poznan, Poland
1222.27.48004 Boehringer Ingelheim Investigational Site
Proszowice, Poland
Romania
1222.27.40003 Boehringer Ingelheim Investigational Site
Bucharest, Romania
1222.27.40002 Boehringer Ingelheim Investigational Site
Bucharest, Romania
Slovakia
1222.27.42101 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1222.27.42103 Boehringer Ingelheim Investigational Site
Lucenec, Slovakia
1222.27.42104 Boehringer Ingelheim Investigational Site
Martin, Slovakia
1222.27.42102 Boehringer Ingelheim Investigational Site
Spisska Nova Ves, Slovakia
Slovenia
1222.27.38601 Boehringer Ingelheim Investigational Site
Golnik, Slovenia
1222.27.38603 Boehringer Ingelheim Investigational Site
Hoce, Slovenia
1222.27.38605 Boehringer Ingelheim Investigational Site
Kamnik, Slovenia
1222.27.38604 Boehringer Ingelheim Investigational Site
Topolsica, Slovenia
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01013753     History of Changes
Other Study ID Numbers: 1222.27, 2009-013395-48
Study First Received: November 13, 2009
Results First Received: March 28, 2014
Last Updated: June 17, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
Poland: Registration Medicinal Product Medical Device Biocidal Product
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014