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Foster 100/6 mg Nexthaler im Vergleich zu Foster 100/6 mg Druckgasinhalator (pMDI) bei Patienten mit kontrolliertem Asthma. (FORTUNE)

24. Juni 2026 aktualisiert von: Chiesi Farmaceutici S.p.A.

Eine 12-wöchige, multizentrische, randomisierte, doppelblinde Doppel-Dummy-, 2-armige Parallelgruppenstudie zum Vergleich der Wirksamkeit und Sicherheit von Foster 100/6 mg Nexthaler, 2 Inhalationen b.i.d, versus Foster 100/6 mg pMDI, 2 Hübe b.i.d Patienten mit kontrolliertem Asthma

Der Zweck dieser Studie besteht darin, die Nichtunterlegenheit von Foster 100/6 mg Nexthaler gegenüber Foster 100/6 mg pMDI in Bezug auf die Lungenfunktion bei Asthmapatienten sowie die Wirkung der Testbehandlungen in Bezug auf zusätzliche Lungenfunktionsparameter und zu demonstrieren klinische Ergebnismessungen. Der Zweck besteht auch darin, die Sicherheit und Verträglichkeit zu beurteilen.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This was a phase III, multinational, multicentre, randomised, double-blind, double-dummy, active-control, 2-arm parallel group study designed to evaluate the non-inferiority of Foster® NEXThaler® 100/6 µg (400/24 µg/day) versus Foster® pMDI 100/6 µg (400/24 µg/day) in patients with controlled asthma.

The study included the following phases:

  • Pre-Screening Phase (Visit 0): Conducted within a maximum of 7 days before the screening visit (Visit 1), this phase provided patients with study details, obtained informed consent, and outlined medication restrictions.
  • Screening and Run-in Phase (Visit 1, Week -4 to Visit 2, Week -2): Patients underwent eligibility assessments and transitioned into a 4-week open-label run-in period with Foster® pMDI 100/6 µg (400/24 µg/day) to establish baseline parameters.
  • Randomisation Phase (Visit 3, Week 0): Eligible patients were randomised in a 1:1 ratio to receive either Foster® NEXThaler® 100/6 µg 2 inhalations bid (for a total daily dose of 400/24 µg/day) or Foster® pMDI 100/6 µg, 2 puffs bid (for a total daily dose of 400/24 µg/day) for 12 weeks. The allocation was managed via an Interactive Web Response System (IWRS) to ensure balanced treatment groups.
  • Investigational Phase (Treatment Period: Weeks 0-12): Patients attended scheduled visits at Weeks 2, 4, 6, 8, 10, and 12 to monitor efficacy and safety.

Daily, patients recorded pre-dose morning and evening Peak Expiratory Flow (PEF), rescue medication use, and asthma symptoms using an electronic peak flow meter and e-diary. At each visit, lung function (FEV1, FVC, and PEF), asthma symptom scores, and rescue medication use were assessed. Vital signs (heart rate, blood pressure) and safety outcomes (adverse events, serious adverse events, and laboratory assessments) were monitored.

  • Follow-Up Phase: A safety follow-up phone call was conducted 7-10 days after the final visit (Week 12) or early termination to assess any unresolved adverse events (AEs) or new concomitant medications.

The total study duration per participant was 16 weeks, including the 4-week run-in period, 12-week treatment phase, and 1-week follow-up. This design ensured a standardized baseline before randomisation and provided sufficient time to assess both primary and secondary endpoints.

Salbutamol (purchased locally and provided by the Investigator site to the patient) was used as a rescue medication.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

494

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
      • Beijing, China, 100144
        • Chiesi Clinical Trial site 15672
      • Beijing, China
        • Chiesi clinical Trial site 15636
      • Chongqing, China
        • Chiesi Clinical Trial site 15638
      • Guizhou, China
        • Chiesi Clinical Trial site 15670
      • Hebei, China
        • Chiesi clinical Trial Site 15611
      • Jilin City, China
        • Chiesi Clinical trial site 15660
      • Shanghai, China
        • Chiesi Clinical Trial site 15628
      • Shanghai, China
        • Chiesi clinical trial site 15637
      • Shenzhen, China
        • Chiesi Clinical Trial site 15666
      • Sichuan, China
        • Chiesi clinical Trial site 15633
      • Ürümqi, China, 830054
        • Chiesi Clinical Trial site 15669
    • Anhui
      • Hefei, Anhui, China
        • Chiesi Clinical Trial site 15641
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Chiesi Clinical Trial site 15682
      • Beijing, Beijing Municipality, China, 101100
        • Chiesi Clinical Trial site 15663
    • Guangdong
      • Foshan, Guangdong, China
        • Chiesi Clinical Trial site 15662
      • Guangzhou, Guangdong, China, 5100150
        • Chiesi Clinical Trial site 15671
      • Guangzhou, Guangdong, China, 510120
        • Chiesi Clinical Trial site 15610
      • Guangzhou, Guangdong, China
        • Chiesi clinical Trial site 15656
      • Guangzhou, Guangdong, China
        • Chiesi Clinical Trial site 15668
      • Huizhou, Guangdong, China, 516001
        • Chiesi Clinical Trial site 15677
      • Shenzhen, Guangdong, China, 518052
        • Chiesi Clinical Trial site 15683
      • Shenzhen, Guangdong, China
        • Chiesi Clinical Trial site 15608
      • Zhanjiang, Guangdong, China, 524001
        • Chiesi Clinical Trial site 15607
    • Guangzhou
      • Guangzhou, Guangzhou, China, 511400
        • Chiesi Clinical Trial site 15610
    • Hainan
      • Haikou, Hainan, China, 570208
        • Chiesi Clinical Trial site 15673
    • Heilongjiang
      • Qiqihar, Heilongjiang, China, 161002
        • Chiesi Clinical Trial site 15678
    • Henan
      • Xinxiang, Henan, China, 453000
        • Chiesi Clinical Trial site 15681
      • Zhengzhou, Henan, China, 450003
        • Chiesi Clinical Trial site 15679
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Chiesi Clinical Trial site 15614
      • Wuhan, Hubei, China
        • Chiesi Clinical Trial site 15661
    • Hunan
      • Hengyang, Hunan, China, 421000
        • Chiesi Clinical Trial site 15675
    • Jiangsu
      • Changzhou, Jiangsu, China, 213164
        • Chiesi Clinical Trial site 15643
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337055
        • Chiesi Clinical Trial site 15674
    • Jilin
      • Jilin City, Jilin, China, 132011
        • Chiesi Clinical Trial site 15676
    • Liaoning
      • Shenyang, Liaoning, China
        • Chiesi clinical Trial site 15621
    • Nanchang
      • Nanchang, Nanchang, China, 330006
        • Chiesi clinical Trial site 15619
    • Neimenggu
      • Hohhot, Neimenggu, China, 010017
        • Chiesi Clinical Trial site 15650
      • Hohhot, Neimenggu, China
        • Chiesi clinical Trial site 15659
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai Municipality, China, 200050
        • Chiesi Clinical Trial site 15664
      • Shanghai, Shanghai Municipality, China, 201100
        • Chiesi Clinical Trial site 15654
      • Shanghai, Shanghai Municipality, China
        • Chiesi Clinical Trial site 15630
      • Shanghai, Shanghai Municipality, China
        • Chiesi Clinical Trial site 15631
      • Shanghai, Shanghai Municipality, China
        • Chiesi Clinical Trial site 15665
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Chiesi Clinical Trial site 15625
    • Shijiazhuang
      • Shijiazhuang, Shijiazhuang, China, 050000
        • Chiesi clinical Trial Site 15611
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Chiesi clinical Trial site 15633
      • Chongqing, Sichuan, China, 408499
        • Chiesi Clinical Trial site 15680
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Chiesi Clinical Trial site 15642
      • Tianjin, Tianjin Municipality, China, 300350
        • Chiesi Clinical Trial site 15634
    • Xian
      • Xi'an, Xian, China, 710061
        • Chiesi Clinical Trial site 15626

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Ambulante männliche oder weibliche Patienten chinesischer Abstammung im Alter von > 18 Jahren mit einer klinischen Diagnose von Asthma für mindestens 6 Monate vor dem Besuch 1, die von einem Thoraxarzt gemäß den aktualisierten internationalen Richtlinien der Global Initiative Asthma (GINA) von 2016 bestätigt wurde.
  • Positive Reaktion auf den Reversibilitätstest.
  • FEV 1 (Forced Expiratory Volume within the first second) > 80 % des vorhergesagten Normalwerts nach angemessener Auswaschung durch Bronchodilatatoren.
  • Patienten, die zuvor mindestens 3 Monate vor Besuch 1 regelmäßig mit einer stabilen Dosis behandelt wurden, entweder mit einer hohen Tagesdosis von ICS (inhalative Kortikosteroide) oder einer mittleren Tagesdosis von ICS

Ausschlusskriterien:

  • Schwangere oder stillende Frauen
  • Intermittierendes Asthma oder Asthma, das nur aufgrund einer episodischen Exposition gegenüber einem Allergen oder einem chemischen Sensibilisator auftritt
  • Diagnose der chronisch obstruktiven Lungenerkrankung (COPD) gemäß Definition in den aktuellen Richtlinien der Glocal Initiative for Chronic Obstructive Lung Disease (GOLD), aktualisiert 2016
  • Aktuelle Raucher oder Ex-Raucher
  • Schwere Asthma-Exazerbation, die zur Einnahme von systemischen Kortikosteroiden (> 10 Tage) innerhalb von 1 Monat vor der Aufnahme führt, oder mittelschwere/schwere Asthma-Exazerbationen
  • Patienten, die mit monoklonalen Antikörpern behandelt wurden
  • Patienten, die mit nicht kaliumsparenden Diuretika behandelt wurden
  • Patienten, die mit Monoaminoxidase-Hemmern und trizyklischen Antidepressiva behandelt werden
  • Patienten, die eine Therapie erhalten, die mit Steroiden interagieren könnte

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Foster 100/6µg NEXThaler

Patients in this arm received Foster® NEXThaler® 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).

Treatment Details:

  • Dosage: 2 inhalations twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily.
  • Duration: 12 weeks.
  • Administration: First dose under medical supervision at randomization (Week 0).

Blinding & Control Treatment:

  • A double-dummy design was used. Patients also received a placebo pMDI (matching active pMDI), administered as 2 puffs b.i.d. to maintain blinding.

Background Therapy:

  • Salbutamol was provided as rescue medication.

Patient Training & Compliance:

  • Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Arzneimittel: Foster 100/6µg NEXThaler
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).
Andere Namen:
  • beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer
Aktiver Komparator: Foster 100/6µg pMDI

Patients in this arm received Foster® pMDI 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI).

Treatment Details:

  • Dosage: 2 puffs twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily.
  • Duration: 12 weeks.
  • Administration: First dose under medical supervision at randomization (Week 0).

Blinding & Control Treatment:

  • A double-dummy design was used. Patients also received a placebo DPI (matching active DPI), administered as 2 inhalations b.i.d. to maintain blinding.

Background Therapy:

  • Salbutamol was provided as rescue medication.

Patient Training & Compliance:

  • Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Arzneimittel: Foster 100/6µg pMDI
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI) with HFA_134a propellant.
Andere Namen:
  • beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)
Zeitfenster: Baseline (Week 0, Visit 3) and Week 12 (EoT)

PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration.

In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose morning PEF over the entire treatment period was computed as:

    ∑Valid pre-dose morning Best PEF values (treatment period) / Number of days with available data

  • Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Baseline (Week 0, Visit 3) and Week 12 (EoT)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: in the morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose morning PEF for each inter-visit period was computed as:

    ∑all valid pre-dose morning Best PEF values / number of days with available data

  • Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Pre-dose Evening PEF
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline pre-dose evening PEF was calculated as the mean of all valid pre-dose evening Best PEF values from the last 14 days before randomization (Week 0, Visit 3).

  • The average pre-dose evening PEF for each inter-visit period was computed as:

    ∑all valid pre-dose evening Best PEF values / number of days with available data

  • Valid pre-dose evening Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Daily PEF Variability
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded.

  • Baseline average daily PEF variability was calculated as the mean of all daily PEF variability values recorded in the last 14 days before randomization (Week 0, Visit 3).

  • The average daily PEF variability for each inter-visit period was computed as:

    ∑all daily PEF variability values / number of days with available data

  • Daily PEF variability was calculated only for days where both pre-dose morning Best PEF and pre-dose evening Best PEF values were available.
  • Valid Best PEF values were defined as the highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Use of Rescue Medication (Number of Puffs/Day)
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.

  • Baseline rescue medication use was the mean daily use over the last 14 days before randomization (Week 0, Visit 3).

  • Average daily use of rescue medication was calculated as:

    • all puffs per day / number of days with available data
  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Rescue Medication-Free Days
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning.

  • Baseline percentage of rescue medication-free days was calculated over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of rescue medication-free days was calculated as:

(Number of days with no rescue medication use / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Morning Asthma Symptom Score
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows:

Daytime asthma symptom score (ranging 0-3, where the lower the score the better the outcome):

0 No symptom

  1. Mild: symptoms not causing awakening
  2. Moderate: discomfort causing awakenings
  3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (recorded in the evening session, as per study methodology).

Total average Daily Asthma Symptoms score daytime = Σ(Cough daytime score + Wheeze daytime score + Chest Tightness daytime score + Breathlessness daytime score)/ Number of days with available data.

The average of daytime asthma symptoms is the mean value of all daytime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Evening Asthma Symptom Scores
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows:

Nighttime asthma symptom score (ranging 0-3, where the lower the score the better the outcome):

0 No symptom

  1. Mild: symptoms not causing awakening
  2. Moderate: discomfort causing awakenings
  3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (Recorded in the morning session of the next day).

Total average Daily Asthma Symptoms score nighttime = Σ(Cough nighttime score + Wheeze nighttime score + Chest Tightness nighttime score + Breathlessness nighttime score)/ Number of days with available data.

The average of nighttime asthma symptoms is the mean value of all nighttime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Symptom-Free Days
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

An asthma symptom-free day was defined as a day with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included.

  • Baseline percentage of symptom-free days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of asthma symptom-free days was calculated as:

(Number of symptom-free days / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Control Days
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks

An asthma control day was defined as a day without rescue medication use and with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included in the calculation.

  • Baseline percentage of asthma control days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3).
  • Percentage of asthma control days was calculated as:

(Number of asthma control days / Total number of days with available data)×100

  • It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end).
  • At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline in Pre-Dose Morning FEV1 at Each Clinic Visit
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

Forced Expiratory Volume in 1 second (FEV1) was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FEV1 was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12).

Patients performed spirometry in a seated position, using the same calibrated spirometer across all visits. They inhaled deeply to total lung capacity and exhaled forcefully and completely. At least three acceptable maneuvers were required, with the highest valid measurement recorded. FEV1 was expressed in liters (L), and a higher value indicated better lung function.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline in Pre-Dose Morning FVC at Each Clinic Visit
Zeitfenster: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)

Forced vital capacity (FVC) is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. FVC was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FVC was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12).

Patients performed spirometry in a seated position, ensuring consistency across visits. They were instructed to inhale deeply to full lung capacity and exhale forcefully and completely into the spirometer. At least three acceptable maneuvers were required per session, with the highest valid measurement recorded. The higher the capacity, measured in liters, the better the outcome.
Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Last Visit in ACQ-6 Score
Zeitfenster: Week 12 (Visit 9, End of Treatment - EOT)

The ACQ-6 was a validated questionnaire assessing asthma control, consisting of six items: five on asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and one on rescue medication use, all self-administered. Each item was scored from 0 (no impairment) to 6 (maximum impairment), and the ACQ-6 total score was the mean of all six items, ranging from 0 (totally controlled asthma) to 6 (severely uncontrolled asthma). Hence, the higher the score, the worse the outcome.

Baseline ACQ-6 was assessed at Visit 3 (Week 0, randomization), and the final score was recorded at Visit 9 (Week 12, EOT). The change from baseline was calculated as the difference between these values .
Week 12 (Visit 9, End of Treatment - EOT)
Number of Participants With at Least One Adverse Event (TEAE) or Adverse Drug Reaction (ADR)
Zeitfenster: From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)

An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered".

An SAE/serious ADR was defined as any untoward medical occurrence or effect that at any dose Resulted in death, Was life-threatening, Required hospitalisation or prolongation of existing hospitalisation, Resulted in persistent or significant disability or incapacity, Was a congenital anomaly or birth defect, Was a medically significant AE.
From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)

Mitarbeiter und Ermittler

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Sponsor

Chiesi Farmaceutici S.p.A.

Ermittler

  • Hauptermittler: Jinping MD Zheng, The First Affiliated Hospital of Guangzhou Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Oktober 2017

Primärer Abschluss (Tatsächlich)

28. Dezember 2021

Studienabschluss (Tatsächlich)

28. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

12. Februar 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Februar 2018

Zuerst gepostet (Tatsächlich)

5. März 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CCD-01535BA0-01
  • CTR20170917 (Andere Kennung: http://www.chinadrugtrials.org.cn/)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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