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治験 NCT06067828 (ATHLOS)（対象：慢性閉塞性肺疾患（COPD））は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (ATHLOS)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06067828 (ATHLOS) は 慢性閉塞性肺疾患（COPD） に関する 治療 の研究で、第III相・第三段階 介入研究 臨床試験 です。現在は 募集中 で、2023年10月24日 から開始しています。180 名の参加者 の募集が計画されています。この治験は アストラゼネカ によって主催され、2026年1月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年10月8日 です。
概要
This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
詳細説明
This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy.

Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.

公式タイトル

A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)

疾患／病気
慢性閉塞性肺疾患（COPD）
その他の研究識別子
  • ATHLOS
  • D5988C00001
NCT番号
NCT06067828
開始日
2023-10-24
最終更新日
2025-10-08
終了予定日
2026-01-30
目標参加者数
180
試験の種類
介入研究
治験の相・段階
第III相・第三段階
状況
募集中
キーワード
Metered Dose Inhalers
主目的
治療
割付方法
無作為化
介入モデル
交叉・クロスオーバー
盲検化
二重盲検
群（アーム）／介入
参加グループ/群介入/治療法
実薬対照薬BGF MDI
Pressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation.
Treatment a : Budesonide, Glycopyrronium, and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
実薬対照薬BFF MDI
Pressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation.
Treatment B: Budesonide and Formoterol Fumarate
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
プラセボ対照薬Placebo
Placebo as pressurized inhalation suspension.
Treatment C : Placebo
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
主要評価項目
評価指標指標の説明時間枠
Change from baseline in isotime Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to Placebo MDI and BGF MDI relative to BFF MDI on dynamic hyperinflation in participants with COPD.
2 weeks post-treatment
副次評価項目
評価指標指標の説明時間枠
Change from baseline in constant work rate cycle ergometry endurance time
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on exercise endurance time in participants with COPD.
2 weeks post-treatment
Change from baseline in Isotime dyspnea (NRS)
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on Isotime dyspnea in participants with COPD.
2 weeks post-treatment
Change from baseline in functional residual capacity (FRC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on FRC in participants with COPD.
2 weeks post-treatment
Change from baseline in total lung capacity (TLC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on TLC in participants with COPD.
2 weeks post-treatment
Change from baseline in residual volume (RV)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV in participants with COPD.
2 weeks post-treatment
Change from baseline in RV/TLC
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV/TLC in participants with COPD.
2 weeks post-treatment
Change from baseline in specific airway conductance (sGaw)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on sGaw in participants with COPD.
2 weeks post-treatment
Change from baseline in static Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on static IC in participants with COPD.
2 weeks post-treatment
Number of participants with serious adverse events (SAEs) and adverse event leading to discontinuation of study intervention (DAEs).
To assess the safety and tolerability of BGF MDI and BFF MDI.
2 weeks post-treatment
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
40 Years
対象性別
全て

  • Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.

  • Participant must have:

    • a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) < 0.7 at Visit 1
    • a post-bronchodilator FEV1 ≥ 30% and <80% predicted normal (moderate to severe COPD) at Visit 1.
    • a score of ≥ 2 on the modified Medical Research Council at Visit 1.
    • pre-bronchodilator FRC of > 120% of predicted normal FRC values at Visit 1.
    • a constant work rate test endurance time of 3 to 8 minutes at Visit 2.

  • Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.

  • Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking

  • Body mass index < 40 kg/m2.

  • Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception.

  • A current diagnosis of asthma, asthma- COPD-overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease and pulmonary hypertension.
  • Historical or current evidence of a clinically significant disease
  • Participants on oxygen therapy or that desaturate significantly (<82%) during exercise.
  • Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
  • Participants who have cancer that has not been in complete remission for at least 5 years.
  • Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator.
  • Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
  • Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler.
  • Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
  • A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1.
  • Participants with contraindications to cardiopulmonary exercise testing (CPET).
  • Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period.
  • Participants with lung lobectomy, lung volume reduction or lung transplantation.
  • Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit.
  • Known history of drug or alcohol abuse within 12 months.
  • Any regular recreational use of marijuana in the 12 months.
AstraZeneca logoアストラゼネカ778 件のアクティブな治験を探索
試験中央連絡先
連絡先: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
37 8カ国の場所

California

Research Site, Los Angeles, California, 90095, United States
募集未定
Research Site, Tarzana, California, 91356, United States
募集未定
Research Site, Torrance, California, 90502, United States
募集中

Florida

Research Site, Brooksville, Florida, 34613, United States
募集中

South Carolina

Research Site, Anderson, South Carolina, 29621, United States
募集中
Research Site, Greenville, South Carolina, 29615, United States
募集中
Research Site, Spartanburg, South Carolina, 29303, United States
募集中
Research Site, CABA, 1426, Argentina
撤回
Research Site, Ciudad de Buenos Aires, C1280AEB, Argentina
撤回
Research Site, Quilmes, B1878FNR, Argentina
撤回

Alberta

Research Site, Edmonton, Alberta, T6G 2B7, Canada
募集中

Ontario

Research Site, Kingston, Ontario, K7L 2V7, Canada
募集中

Quebec

Research Site, Sainte-Foy, Quebec, G1V 4G5, Canada
募集中
Research Site, Guangzhou, 510163, China
募集中
Research Site, Nanchang, 330006, China
募集中
Research Site, Shenyang, 110001, China
募集中
Research Site, Zhengzhou, 450000, China
募集中
Research Site, Berlin, 12159, Germany
募集中
Research Site, Berlin, 14050, Germany
募集中
Research Site, Frankfurt, 60596, Germany
募集中
Research Site, Großhansdorf, 22927, Germany
募集中
Research Site, Hanover, 30449, Germany
募集中
Research Site, Heidelberg, 69115, Germany
募集中
Research Site, Lübeck, 23552, Germany
募集中
Research Site, Mainz, 55128, Germany
募集中
Research Site, Daegu, 42415, South Korea
募集中
Research Site, Seoul, 02447, South Korea
募集中
Research Site, Seoul, 05030, South Korea
募集中
Research Site, Benalmádena, 29630, Spain
募集中
Research Site, Madrid, 28007, Spain
募集中
Research Site, Santiago de Compostela, 15706, Spain
募集未定
Research Site, Seville, 41013, Spain
募集未定
Research Site, Leeds, LS9 7TF, United Kingdom
撤回
Research Site, Leicester, LE1 5WW, United Kingdom
募集中
Research Site, London, SW3 6HP, United Kingdom
募集中
Research Site, London, W1T 6AH, United Kingdom
募集中
Research Site, Manchester, M23 9GP, United Kingdom
募集中