AsthmaPhase 2NCT00350207
Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg
A Phase 2 study testing Tiotropium bromide and Salmeterol xinafoate in people with Asthma, run by Boehringer Ingelheim at 109 sites in 14 countries.
Trial summary
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tiotropium bromide and Salmeterol xinafoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 109 sitesin 14 countries
- Study dates
- Jul 2006to Sep 2008
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion_Criteria:
- Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
- All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
- Male or female outpatients with at least 18 years of age, but not older than 65 years
- Patients must have a documented history of asthma
- Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years
- Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent
Exclusion_Criteria:
- Patients with a significant disease other than asthma
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within 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 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 with a diagnosis of chronic obstructive pulmonary disease (COPD)
- Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- Patients with known active tuberculosis
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.
Trial locations and contacts
109 sites in 14 countries.
109 sites in 14 countries
Germany14 sites
205.342.49016 Boehringer Ingelheim Investigational Site
Beelitz-Heilstätten
205.342.49004 Boehringer Ingelheim Investigational Site
Berlin
205.342.49006 Boehringer Ingelheim Investigational Site
Berlin
205.342.49013 Boehringer Ingelheim Investigational Site
Berlin
205.342.49003 Boehringer Ingelheim Investigational Site
Bruchsal
205.342.49009 Boehringer Ingelheim Investigational Site
Cologne
205.342.49011 Boehringer Ingelheim Investigational Site
Frankfurt am Main
205.342.49007 Boehringer Ingelheim Investigational Site
Kassel
205.342.49010 Boehringer Ingelheim Investigational Site
Mainz
205.342.49008 Boehringer Ingelheim Investigational Site
Minden
205.342.49015 Boehringer Ingelheim Investigational Site
Neuruppin
205.342.49012 Boehringer Ingelheim Investigational Site
Rathenow
205.342.49005 Boehringer Ingelheim Investigational Site
Rüdersdorf
205.342.49002 Boehringer Ingelheim Investigational Site
Weinheim
Belgium13 sites
205.342.32010 Boehringer Ingelheim Investigational Site
Anderlecht
205.342.32005 Boehringer Ingelheim Investigational Site
Angleur
205.342.32002 Boehringer Ingelheim Investigational Site
Brussels
205.342.32007 Boehringer Ingelheim Investigational Site
Brussels
205.342.32014 Boehringer Ingelheim Investigational Site
Brussels
205.342.32001 Boehringer Ingelheim Investigational Site
Ghent
205.342.32003 Boehringer Ingelheim Investigational Site
Herentals
205.342.32004 Boehringer Ingelheim Investigational Site
Malmedy
205.342.32012 Boehringer Ingelheim Investigational Site
Menen
205.342.32006 Boehringer Ingelheim Investigational Site
Montigny-le-Tilleul
205.342.32009 Boehringer Ingelheim Investigational Site
Namur
205.342.32011 Boehringer Ingelheim Investigational Site
Turnhout
205.342.32013 Boehringer Ingelheim Investigational Site
Yvoir
Spain10 sites
205.342.34006 Hospital Clinic i Provincial de Barcelona
Barcelona
205.342.34011 Boehringer Ingelheim Investigational Site
Centelles
205.342.34004 Hospital General Universitario de Guadalajara
Guadalajara
205.342.34002 Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria
205.342.34007 Hospital Universitari Arnau de Vilanova
Lleida
205.342.34003 Hospital Universitario La Paz
Madrid
205.342.34009 Hospital Universio Puerta del Hierro
Madrid
205.342.34008 Hospital Universitario Marqués de Valdecilla
Santander
205.342.34005 Hospital Vírgen de la Macarena
Seville
205.342.34010 Hospital General Universitario de Valencia
Valencia
France8 sites
205.342.3305A Centre Hosp de la Cavale Blanche
Brest
205.342.3304A Cabinet Médical
Chamalières
205.342.3307A Boehringer Ingelheim Investigational Site
Chauny
205.342.3301A UCP-X - Clinique Médicale
Grenoble
205.342.3302A Hôpital Arnaud de Villeneuve
Montpellier
205.342.3306A Mediscis
Poitiers
205.342.3308A Boehringer Ingelheim Investigational Site
Saint Pierre La Réunion
205.342.3308B Boehringer Ingelheim Investigational Site
Saint Pierre La Réunion
Italy8 sites
205.342.39003 Azienda Ospedaliera " S. Anna"
Ferrara
205.342.39006 Azienda Ospedaliera Universitaria Careggi
Florence
205.342.39005 Ospedale San Martino
Genova
205.342.39002 Università di Modena e Reggio Emilia
Modena
205.342.39010 Boehringer Ingelheim Investigational Site
Orbassano (to)
205.342.39007 Policlinico San Matteo
Pavia
205.342.39001 Ospedale di Cisanello
Pisa
205.342.39009 Boehringer Ingelheim Investigational Site
Sesto San Giovanni (mi)
Russia8 sites
205.342.07001 Boehringer Ingelheim Investigational Site
Moscow
205.342.07002 Boehringer Ingelheim Investigational Site
Moscow
205.342.07003 Boehringer Ingelheim Investigational Site
Moscow
205.342.07004 Boehringer Ingelheim Investigational Site
Moscow
205.342.07005 Boehringer Ingelheim Investigational Site
Moscow
205.342.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.342.07007 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.342.07008 Boehringer Ingelheim Investigational Site
Saint Petersburg
Slovakia8 sites
205.342.42101 Boehringer Ingelheim Investigational Site
Banská Bystrica
205.342.42102 Boehringer Ingelheim Investigational Site
Bratislava
205.342.42104 Boehringer Ingelheim Investigational Site
Bratislava
205.342.42105 Boehringer Ingelheim Investigational Site
Bratislava
205.342.42107 Boehringer Ingelheim Investigational Site
Bratislava
205.342.42103 Boehringer Ingelheim Investigational Site
Košice
205.342.42106 Boehringer Ingelheim Investigational Site
Trenčín
205.342.42108 Boehringer Ingelheim Investigational Site
Žilina
South Africa8 sites
205.342.27002 Boehringer Ingelheim Investigational Site
Bellville
205.342.27008 Boehringer Ingelheim Investigational Site
Bloemfontein
205.342.27001 Boehringer Ingelheim Investigational Site
Cape Town
205.342.27004 Boehringer Ingelheim Investigational Site
Cape Town
205.342.27006 Boehringer Ingelheim Investigational Site
Centurion
205.342.27003 Boehringer Ingelheim Investigational Site
Durban
205.342.27007 Boehringer Ingelheim Investigational Site
George
205.342.27005 Boehringer Ingelheim Investigational Site
Pretoria
Austria7 sites
205.342.43002 Boehringer Ingelheim Investigational Site
Graz
205.342.43004 Boehringer Ingelheim Investigational Site
Trofaiach
205.342.43001 Boehringer Ingelheim Investigational Site
Vienna
205.342.43005 Boehringer Ingelheim Investigational Site
Vienna
205.342.43006 Boehringer Ingelheim Investigational Site
Vienna
205.342.43007 Boehringer Ingelheim Investigational Site
Vienna
205.342.43003 Boehringer Ingelheim Investigational Site
Wels
Greece6 sites
205.342.30001 Boehringer Ingelheim Investigational Site
Athens
205.342.30002 Boehringer Ingelheim Investigational Site
Athens
205.342.30005 Boehringer Ingelheim Investigational Site
Heraklion
205.342.30006 Boehringer Ingelheim Investigational Site
Kavala
205.342.30004 Boehringer Ingelheim Investigational Site
Larissa
205.342.30003 Boehringer Ingelheim Investigational Site
Thessaloniki
Turkey (Türkiye)6 sites
205.342.90001 Boehringer Ingelheim Investigational Site
Ankara
205.342.90006 Boehringer Ingelheim Investigational Site
Ankara
205.342.90003 Boehringer Ingelheim Investigational Site
Bursa
205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul
205.342.90005 Kocaeli Universitesi Tip Fakultesi
İzmit
205.342.90004 Celal Bayar Universitesi Tip Fakultesi
Manisa
United Kingdom5 sites
205.342.44002 Boehringer Ingelheim Investigational Site
Aylesbury
205.342.44001 Boehringer Ingelheim Investigational Site
Chertsey
205.342.44003 Boehringer Ingelheim Investigational Site
Greenisland
205.342.44006 Boehringer Ingelheim Investigational Site
Leicester
205.342.44005 Boehringer Ingelheim Investigational Site
Nottingham
Denmark4 sites
205.342.45003 Boehringer Ingelheim Investigational Site
Aalborg
205.342.45001 Boehringer Ingelheim Investigational Site
Hvidovre
205.342.45002 Boehringer Ingelheim Investigational Site
København NV
205.342.45004 Boehringer Ingelheim Investigational Site
Odense C
Finland4 sites
205.342.35803 Boehringer Ingelheim Investigational Site
Helsinki
205.342.35801 Boehringer Ingelheim Investigational Site
Jyväskylä
205.342.35802 Boehringer Ingelheim Investigational Site
Lahti
205.342.35804 Boehringer Ingelheim Investigational Site
Tampere
About this study
Official title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.
The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
- Conditions
- Asthma
- Being tested
- Tiotropium bromide, Placebo, Salmeterol xinafoate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium bromideDrug
PlaceboDrug
Salmeterol xinafoateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit
Measured: baseline and after 16 weeks of treatment
Secondary outcomes (62)
Mean Weekly Morning Peak Expiratory Flow at Week 4
Mean weekly morning peak expiratory flow at week 4, pre-dose
Measured: After 4 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 8
Mean weekly morning peak expiratory flow at week 8, pre-dose
Measured: After 8 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 12
Mean weekly morning peak expiratory flow at week 12, pre-dose
Measured: After 12 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 16
Mean weekly morning peak expiratory flow at week 16, pre-dose
Measured: After 16 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 4
Mean weekly evening peak expiratory flow at week 4, pre-dose
Measured: After 4 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 8
Mean weekly evening peak expiratory flow at week 8, pre-dose
Measured: After 8 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 12
Mean weekly evening peak expiratory flow at week 12, pre-dose
Measured: After 12 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 16
Mean weekly evening peak expiratory flow at week 16, pre-dose
Measured: After 16 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
Measured: After 4 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
Measured: After 8 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
Measured: After 12 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
Measured: After 16 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
Measured: After 4 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
Measured: After 8 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
Measured: After 12 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16
Unit on a scale 1-5. 1: Did not wake up, 2: Woke up once, 3: Woke up 2-5 times, 4: Woke up more than 5 times, 5: Was awake all night. 1 is the best value
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
Unit on a scale 1-5. 1: No asthma symptoms, 2: Mild asthma symptoms, 3: Moderate asthma symptoms, 4: Severe asthma symptoms, 5: Very severe asthma symptoms. 1 is the best value
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16
Unit on a scale 1-5. 1: Not limited at all, 2: A little limited, 3: Moderately limited, 4: Severely limited, 5: Totally limited. 1 is the best value
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16
Unit on a scale 1-5. 1: None, 2: A very little, 3: A moderate amount, 4: Quite a lot, 5: A very great deal. 1 is the best value
Measured: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Measured: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Measured: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Measured: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16
Unit on a scale 1-5. 1: Not at all, 2: A little of the time, 3: A moderate amount of the time, 4: Most of the time, 5: All the time. 1 is the best value
Measured: After 16 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment
Measured: After 6 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment
Measured: After 12 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment
Measured: After 16 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
Measured: After 6 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
Measured: After 12 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
Measured: After 16 weeks of treatment
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Measured: After 6 weeks of treatment
Mini-AQLQ Overall Score at Visit 4
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Measured: After 12 weeks of treatment
Mini-AQLQ Overall Score at Visit 5
Mean of the responses to 15 questions from 4 domains: Symptoms (1), Activity Limitations (2), Emotional Function (3), Environmental Stimuli (4). Unit on a scale 1-7. For domain (2): 1: totally limited, 2: extremely limited, 3: very limited, 4: moderate limitation, 5: some limitation, 6: a little limitation, 7: not at all limited. For other domains: 1: all of the time, 2: most of the time, 3: a good bit of the time, 4: some of the time, 5: a little of the time, 6: hardly any of the time, 7: none of the time. 7 is the best value
Measured: After 16 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
Systolic blood pressure collected in conjunction with spirometry at 6 weeks
Measured: After 6 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
Systolic blood pressure collected in conjunction with spirometry at 12 weeks
Measured: After 12 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
Systolic blood pressure collected in conjunction with spirometry at 16 weeks
Measured: After 16 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
Measured: After 6 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
Measured: After 12 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
Measured: After 16 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 3
Pulse rate collected in conjunction with spirometry at 6 weeks
Measured: After 6 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 4
Pulse rate collected in conjunction with spirometry at 12 weeks
Measured: After 12 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 5
Pulse rate collected in conjunction with spirometry at 16 weeks
Measured: After 16 weeks of treatment
Mean PEF Variability at Week 4
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Measured: After 4 weeks of treatment
Mean PEF Variability at Week 8
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Measured: After 8 weeks of treatment
Mean PEF Variability at Week 12
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Measured: After 12 weeks of treatment
Mean PEF Variability at Week 16
PEF (Peak expiratory flow) variability is defined as the difference between the highest morning PEF value and the highest evening PEF value of one day divided by the arithmetic mean of these two PEF values and multiplied by 100%
Measured: After 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350207
- Sponsor's protocol ID
- 205.342
- Status last verified
- Sep 2013
- First submitted
- 7 Jul 2006
- Last updated
- 24 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.
PubMed 21807250
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
- ClinicalTrials.gov ID
- NCT00350207
- Acronym / sponsor ID
- 205.342
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 17 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.
The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium bromide | Drug | – |
| Placebo | Drug | – |
| Salmeterol xinafoate | Drug | – |
Primary outcome
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Time frame: baseline and after 16 weeks of treatment
Change from baseline in mean weekly morning peak expiratory flow at 16 weeks. Baseline is defined as the last week prior to the randomisation visit
62 secondary outcomes
Mean Weekly Morning Peak Expiratory Flow at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Wake up During the Night Due to Asthma" at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Limited Were You in Your Activities Today Because of Your Asthma" at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Much Shortness of Breath Did You Experience During the Day" at Week 16
Time frame: After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 4
Time frame: After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 8
Time frame: After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 12
Time frame: After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "Did You Experience Wheeze or Cough During the Day" at Week 16
Time frame: After 16 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Derived from this study: PubMed 21807250Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
109 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium bromide and Salmeterol xinafoate in people with Asthma, run by Boehringer Ingelheim at 109 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in Germany, Belgium, Spain, France, Italy and 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Nov 2009). 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?
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (time frame: baseline and after 16 weeks of treatment). 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 NCT00350207, which also lists 2 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 24 Dec 2013.