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制御された喘息患者におけるフォスター 100/6 mg NEXThaler とフォスター 100/6 mg 加圧定量吸入器 (pMDI) の比較。 (FORTUNE)

2026年6月24日 更新者：Chiesi Farmaceutici S.p.A.

Foster 100/6mg pMDI、2 パフ b.i.d と比較した Foster 100/6mg NEXThaler、2 回吸入 b.i.d の有効性と安全性を比較する 12 週間、多施設、無作為化、二重盲検、ダブルダミー、2 群並行群間試験喘息がコントロールされている患者

この研究の目的は、喘息患者の肺機能に関して、Foster 100/6mg NEXThaler と Foster 100/6mg pMDI の非劣性、および追加の肺機能パラメータと試験治療の効果を実証することです。臨床転帰測定。 その目的は、安全性と忍容性を評価することでもあります。

調査の概要

状態

状態

現在の募集状況やアクセス拡大状況を示します。
完了

条件

条件

研究されている疾患、障害、症候群、病気、またはけが。 ClinicalTrials.gov では、条件には、寿命、生活の質、健康上のリスクなど、他の健康関連の問題も含まれる場合があります。

介入・治療

介入・治療

臨床研究の焦点となるプロセスまたはアクション。介入には、医薬品、医療機器、処置、ワクチン、および治験中またはすでに利用可能なその他の製品が含まれます。介入には、教育や食事や運動の変更などの非侵襲的アプローチも含まれます。

詳細な説明

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.

研究の種類

研究の種類

臨床研究の性質について説明します。研究の種類には、介入研究 (臨床試験とも呼ばれます)、観察研究 (患者登録を含む)、および拡張アクセスが含まれます。
介入

入学 (実際)

入学

臨床試験の参加者数。 「予想される」登録は、研究者が研究に必要とする参加者の目標数です。
494

段階

段階

米国食品医薬品局 (FDA) によって開発された定義に基づく、医薬品または生物学的製品を研究する臨床試験の段階。フェーズは、研究の目的、参加者の数、およびその他の特性に基づいています。初期フェーズ 1 (以前はフェーズ 0 としてリストされていた)、フェーズ 1、フェーズ 2、フェーズ 3、およびフェーズ 4 の 5 つのフェーズがあります。該当なしは、デバイスまたは行動介入の治験を含む、FDA が定義したフェーズのない治験を説明するために使用されます。
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

適格基準

臨床研究への参加を希望する人々が満たさなければならない重要な要件、または彼らが持つべき特徴。適格基準は、包含基準 (人が研究に参加するために必要な基準) と除外基準 (人が研究に参加するのを妨げる基準) の両方で構成されます。適格基準のタイプには、研究が健康なボランティアを受け入れるかどうか、年齢または年齢グループの要件があるかどうか、または性別によって制限されるかどうかが含まれます。

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • -男性または女性の外来患者、18歳以上の中国人で、訪問前に最低6か月間喘息の臨床診断を受けている 1 2016年グローバルイニシアチブ喘息（GINA）の更新された国際ガイドラインに従って、胸部医師によって確認されました。
  • 可逆性試験に対する陽性反応。
  • FEV 1 (最初の 1 秒以内の強制呼気量) 気管支拡張薬から適切に洗い流した後の予測正常値の >80%。
  • -訪問1の前に少なくとも3か月間安定した用量で以前の定期的な治療を受けていた患者 ICS（吸入コルチコステロイド）の1日あたりの高用量またはICSの1日あたりの中用量のいずれか

除外基準:

  • 妊娠中または授乳中の女性
  • 間欠性喘息またはアレルゲンまたは化学感作物質への一時的な暴露中にのみ発生する喘息
  • 現在の Glocal Initiative for Chronic Obstructive Lung Disease (GOLD) ガイドラインで定義されている慢性閉塞性肺疾患 (COPD) の診断は、2016 年に更新されました。
  • 現在の喫煙者、または元喫煙者
  • -全身性コルチコステロイドの摂取につながる重度の喘息増悪（> 10日） 組み入れ前の1か月以内または中等度/重度の喘息増悪
  • モノクローナル抗体で治療された患者
  • 非カリウム保持性利尿薬で治療された患者
  • モノアミンオキシダーゼ阻害剤および三環系抗うつ薬で治療されている患者
  • ステロイドと相互作用する可能性のある治療を受けている患者

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム

参加者グループ / アーム

臨床試験のプロトコルに従って、特定の介入/治療を受ける、または介入を受けない、臨床試験の参加者のグループまたはサブグループ。
介入・治療

介入・治療

臨床研究の焦点となるプロセスまたはアクション。介入には、医薬品、医療機器、処置、ワクチン、および治験中またはすでに利用可能なその他の製品が含まれます。介入には、教育や食事や運動の変更などの非侵襲的アプローチも含まれます。
実験的：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.
薬：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).
他の名前：
  • beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer
アクティブコンパレータ：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.
薬：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.
他の名前：
  • beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI

この研究は何を測定していますか？

主要な結果の測定

主要な結果の測定

臨床研究のプロトコルにおいて、介入/治療の効果を評価するために最も重要な、計画された結果の尺度。ほとんどの臨床研究には 1 つの主要な結果の測定値がありますが、複数の測定値を持つものもあります。
結果測定
メジャーの説明
時間枠
Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)
時間枠：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)

二次結果の測定

二次結果の測定

臨床研究のプロトコルにおいて、介入の効果を評価するための主要な結果測定ほど重要ではないが、依然として重要な計画された結果測定。ほとんどの臨床研究には、複数の副次的アウトカム指標があります。
結果測定
メジャーの説明
時間枠
Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

スポンサー

研究を開始し、研究に対する権限と管理権を持つ組織または個人。
Chiesi Farmaceutici S.p.A.

捜査官

捜査官

臨床研究に携わる研究者。関連用語には、施設主任研究者、施設副調査官、研究委員長、研究責任者、および研究主任研究者が含まれます。
  • 主任研究者：Jinping MD Zheng、The First Affiliated Hospital of Guangzhou Medical University

出版物と役立つリンク

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一般刊行物

便利なリンク

研究記録日

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主要日程の研究

研究開始 (実際)

研究開始

最初の参加者が臨床試験に登録された実際の日付。 「予想される」研究開始日は、研究者が研究開始日になると考える日付です。
2017年10月9日

一次修了 (実際)

一次修了

臨床研究の最後の参加者が検査された、または主要な結果測定のための最終データを収集するための介入を受けた日付。治験がプロトコルに従って終了したか終了したかは、この日付には影響しません。完了日が異なる複数の主要評価項目を含む臨床研究の場合、この用語は、すべての主要評価項目のデータ収集が完了した日付を指します。 「予想される」一次完了日は、研究者がその研究の一次完了日になると考える日付です。
2021年12月28日

研究の完了 (実際)

研究の完了

臨床研究の最後の参加者が検査された、または介入/治療を受けて、主要な結果の尺度、副次的な結果の尺度、および有害事象の最終データを収集した日付 (つまり、最後の参加者の最後の訪問)。 「予想される」研究完了日は、研究者が研究完了日になると考える日付です。
2021年12月28日

試験登録日

最初に提出

最初に提出

治験依頼者または治験責任医師が初めて治験記録を ClinicalTrials.gov に提出した日付。通常、最初の提出日と ClinicalTrials.gov での記録の利用可能日 (最初の投稿日) の間には数日の遅延があります。
2018年2月12日

QC基準を満たした最初の提出物

QC基準を満たした最初の提出物

研究スポンサーまたは治験責任医師が、国立医学図書館 (NLM) の品質管理 (QC) 審査基準と一致する研究記録を最初に提出した日付。治験依頼者または研究者は、NLM の QC 審査基準が満たされるまでに、研究記録を 1 回または複数回修正して提出する必要がある場合があります。研究記録がNLM QC審査基準と一致していることを確認するのは、治験依頼者または治験責任医師の責任です。
2018年2月26日

最初の投稿 (実際)

最初の投稿

国立医学図書館 (NLM) の品質管理 (QC) レビューが終了した後、ClinicalTrials.gov で研究記録が最初に利用可能になった日付。通常、治験依頼者または治験責任医師が治験記録を提出した日と最初に投稿された日との間には数日の遅延があります。
2018年3月5日

学習記録の更新

投稿された最後の更新 (実際)

投稿された最後の更新

ClinicalTrials.gov で、研究記録が変更された最新の日付。研究のスポンサーまたは治験責任医師によって変更が ClinicalTrials.gov に提出されたとき (最終更新が提出された日) と最終更新が投稿された日との間に遅延が生じる場合があります。
2026年8月10日

QC基準を満たした最後の更新が送信されました

QC基準を満たした最後の更新が送信されました

治験依頼者または治験責任医師が、国立医学図書館（NLM）の品質管理（QC）審査基準と一致する治験記録の変更を提出した最新の日付。研究記録がNLM QC審査基準と一致していることを確認するのは、治験依頼者または治験責任医師の責任です。
2026年6月24日

最終確認日

最終確認日

治験依頼者または治験責任医師が、ClinicalTrials.gov で臨床治験に関する情報が正確かつ最新であることを確認した最新の日付。募集ステータスが募集中の研究の場合。まだ募集していません。過去 2 年以内に募集が確認されていない場合、研究の募集状況は不明として表示されます。
2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

その他の研究ID番号

NCT 番号以外の識別子または ID 番号で、治験依頼者、資金提供者、その他によって臨床治験に割り当てられたもの。これらの番号には、他の治験登録機関や国立衛生研究所の助成金番号からの一意の識別子が含まれる場合があります。
  • CCD-01535BA0-01
  • CTR20170917 (その他の識別子：http://www.chinadrugtrials.org.cn/)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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