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Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

keskiviikko 27. marraskuuta 2013 päivittänyt: Boehringer Ingelheim

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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

388

Vaihe

  • Vaihe 2

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Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion_Criteria:

  1. Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
  2. All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
  3. Male or female outpatients with at least 18 years of age, but not older than 65 years
  4. Patients must have a documented history of asthma
  5. Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years
  6. Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent

Exclusion_Criteria:

  1. Patients with a significant disease other than asthma
  2. Patients with a recent history (i.e., six months or less) of myocardial infarction
  3. Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year
  4. Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
  5. 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.
  6. Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  7. Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
  8. Patients with known active tuberculosis
  9. Patients who have undergone thoracotomy with pulmonary resection.
  10. 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Inventiomalli: Rinnakkaistehtävä

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial
Aikaikkuna: 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
baseline and after 16 weeks of treatment

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mean Weekly Morning Peak Expiratory Flow at Week 4
Aikaikkuna: After 4 weeks of treatment
Mean weekly morning peak expiratory flow at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 8
Aikaikkuna: After 8 weeks of treatment
Mean weekly morning peak expiratory flow at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 12
Aikaikkuna: After 12 weeks of treatment
Mean weekly morning peak expiratory flow at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Morning Peak Expiratory Flow at Week 16
Aikaikkuna: After 16 weeks of treatment
Mean weekly morning peak expiratory flow at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 4
Aikaikkuna: After 4 weeks of treatment
Mean weekly evening peak expiratory flow at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 8
Aikaikkuna: After 8 weeks of treatment
Mean weekly evening peak expiratory flow at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 12
Aikaikkuna: After 12 weeks of treatment
Mean weekly evening peak expiratory flow at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Evening Peak Expiratory Flow at Week 16
Aikaikkuna: After 16 weeks of treatment
Mean weekly evening peak expiratory flow at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 4
Aikaikkuna: After 4 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 8
Aikaikkuna: After 8 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 12
Aikaikkuna: After 12 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Morning Forced Expiratory Volume in 1 Second at Week 16
Aikaikkuna: After 16 weeks of treatment
Mean weekly morning forced expiratory volume in 1 second at week 16, pre-dose
After 16 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 4
Aikaikkuna: After 4 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 4, pre-dose
After 4 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 8
Aikaikkuna: After 8 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 8, pre-dose
After 8 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 12
Aikaikkuna: After 12 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 12, pre-dose
After 12 weeks of treatment
Mean Weekly Evening Forced Expiratory Volume in 1 Second at Week 16
Aikaikkuna: After 16 weeks of treatment
Mean weekly evening forced expiratory volume in 1 second at week 16, pre-dose
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
Aikaikkuna: After 4 weeks of treatment
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
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
Aikaikkuna: After 8 weeks of treatment
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
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
Aikaikkuna: After 12 weeks of treatment
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
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
Aikaikkuna: After 16 weeks of treatment
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
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms in the Morning" at Week 4
Aikaikkuna: After 4 weeks of treatment
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
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 8
Aikaikkuna: After 8 weeks of treatment
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
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 12
Aikaikkuna: After 12 weeks of treatment
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
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms This Morning" at Week 16
Aikaikkuna: After 16 weeks of treatment
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
After 16 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 4
Aikaikkuna: After 4 weeks of treatment
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
After 4 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 8
Aikaikkuna: After 8 weeks of treatment
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
After 8 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 12
Aikaikkuna: After 12 weeks of treatment
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
After 12 weeks of treatment
Mean Weekly Score for Asthma Control Diary Question "How Were Your Asthma Symptoms During the Day" at Week 16
Aikaikkuna: After 16 weeks of treatment
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
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
Aikaikkuna: After 4 weeks of treatment
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
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
Aikaikkuna: After 8 weeks of treatment
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
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
Aikaikkuna: After 12 weeks of treatment
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
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
Aikaikkuna: After 16 weeks of treatment
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
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
Aikaikkuna: After 4 weeks of treatment
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
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
Aikaikkuna: After 8 weeks of treatment
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
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
Aikaikkuna: After 12 weeks of treatment
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
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
Aikaikkuna: After 16 weeks of treatment
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
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
Aikaikkuna: After 4 weeks of treatment
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
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
Aikaikkuna: After 8 weeks of treatment
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
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
Aikaikkuna: After 12 weeks of treatment
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
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
Aikaikkuna: After 16 weeks of treatment
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
After 16 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 3
Aikaikkuna: After 6 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 6 weeks of treatment
After 6 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 4
Aikaikkuna: After 12 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 12 weeks of treatment
After 12 weeks of treatment
Morning Pre-dose Forced Expiratory Volume in 1 Second as Measured by Spirometry at Visit 5
Aikaikkuna: After 16 weeks of treatment
Morning pre-dose forced expiratory volume in 1 second as measured by spirometry after 16 weeks od treatment
After 16 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 3
Aikaikkuna: After 6 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 6 weeks of treatment
After 6 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 4
Aikaikkuna: After 12 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 12 weeks of treatment
After 12 weeks of treatment
Morning Pre-dose Forced Vital Capacity as Measured by Spirometry at Visit 5
Aikaikkuna: After 16 weeks of treatment
Morning pre-dose forced vital capacity as measured by spirometry after 16 weeks of treatment
After 16 weeks of treatment
Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Overall Score at Visit 3
Aikaikkuna: After 6 weeks of treatment
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
After 6 weeks of treatment
Mini-AQLQ Overall Score at Visit 4
Aikaikkuna: After 12 weeks of treatment
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
After 12 weeks of treatment
Mini-AQLQ Overall Score at Visit 5
Aikaikkuna: After 16 weeks of treatment
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
After 16 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 3
Aikaikkuna: After 6 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 4
Aikaikkuna: After 12 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Systolic Blood Pressure in Conjunction With Spirometry at Visit 5
Aikaikkuna: After 16 weeks of treatment
Systolic blood pressure collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 3
Aikaikkuna: After 6 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 4
Aikaikkuna: After 12 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Diastolic Blood Pressure in Conjunction With Spirometry at Visit 5
Aikaikkuna: After 16 weeks of treatment
Diastolic blood pressure collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 3
Aikaikkuna: After 6 weeks of treatment
Pulse rate collected in conjunction with spirometry at 6 weeks
After 6 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 4
Aikaikkuna: After 12 weeks of treatment
Pulse rate collected in conjunction with spirometry at 12 weeks
After 12 weeks of treatment
Pulse Rate in Conjunction With Spirometry at Visit 5
Aikaikkuna: After 16 weeks of treatment
Pulse rate collected in conjunction with spirometry at 16 weeks
After 16 weeks of treatment
Mean PEF Variability at Week 4
Aikaikkuna: After 4 weeks of treatment
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%
After 4 weeks of treatment
Mean PEF Variability at Week 8
Aikaikkuna: After 8 weeks of treatment
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%
After 8 weeks of treatment
Mean PEF Variability at Week 12
Aikaikkuna: After 12 weeks of treatment
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%
After 12 weeks of treatment
Mean PEF Variability at Week 16
Aikaikkuna: After 16 weeks of treatment
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%
After 16 weeks of treatment

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Opiskelun aloitus

Lauantai 1. heinäkuuta 2006

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. syyskuuta 2008

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Ensimmäinen lähetetty

Perjantai 7. heinäkuuta 2006

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 7. heinäkuuta 2006

Ensimmäinen Lähetetty (Arvio)

Maanantai 10. heinäkuuta 2006

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 24. joulukuuta 2013

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 27. marraskuuta 2013

Viimeksi vahvistettu

Sunnuntai 1. syyskuuta 2013

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