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- Sperimentazione clinica NCT02153489
A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
20 settembre 2016 aggiornato da: AstraZeneca
A Pilot, Double-blind, Placebo-controlled, 2-period Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to assess the effect of aclidinium bromide compared with placebo in improving dilatation of the airways (bronchodilation), symptoms of chronic obstructive pulmonary disease (COPD), sleep quality and physical activity after 3 weeks of treatment with aclidinium bromide 400 μg administered twice daily in patients with stable moderate-and-severe COPD.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
30
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Grosshansdorf, Germania, 22927
- Pulmonary Research Institute at the Lung Clinic Grosshansdorf
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Immenhausen, Germania, 34376
- Pneumologische Lehrklinik der Universitätsmedizin Göttingen
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
40 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adult male or non-pregnant, non-lactating female aged ≥40 years. Women of childbearing potential will follow specific study requirements (negative serum pregnancy test at the Screening Visit and are using, over the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control
- Current or ex-cigarette smoker (patients who quit smoking more than 6 months prior to the Screening Visit), with a smoking history of at least 10 pack-years.
- Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD guidelines 2013, with a post bronchodilator FEV1 <80%, and FEV1 ≥ 40% at Screening Visit
- Patients must be able to perform repeatable pulmonary function testing for FEV1 according to American Thoracic Society [ATS]/European Respiratory Society [ERS] 2005 criteria at Screening Visit
- Patients who are eligible and able to participate in the study and who consents to do so in writing after the purpose and nature of the investigation have been explained
Exclusion Criteria:
- History or current diagnosis of asthma
- Patients with moderate to severe sleep apnoea assessed at screening
- Patients who develop a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if hospitalisation was required) before the Screening Visit (Visit 1) or during the run-in period
- Clinically significant respiratory conditions
- Patients with Type I or uncontrolled Type II diabetes, uncontrolled hypo-or hyperthyroidism, hypokalaemia, or hyperadrenergic state, uncontrolled or untreated hypertension
- Patients who may need to start a pulmonary rehabilitation program during the study and/or patients who started/finished it within 3 months prior to the Screening Visit
- Use of long-term oxygen therapy (15 hours/day)
- Patients who does not maintain regular day/night, waking/sleeping cycles including night shift workers
- Clinically significant cardiovascular conditions
- QTc >470 milliseconds in the manual ECG reading performed at Screening Visit
- Patients with clinically relevant abnormalities in the opinion of the investigator at the Screening Visit (Visit 1) in the results of the clinical laboratory tests, ECG parameters or in the physical examination)
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics, long and short acting β2-agonists, sympathomimetic amines, or inhaled medication or any component there of (including report of paradoxical bronchospasm)
- Patients with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy
- Patients with known non-controlled history of human immunodeficiency virus (HIV) infection and/or active hepatitis
- History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years other than basal or squamous cell skin cancer
- Patients with any other serious or uncontrolled physical or mental dysfunction, or moderate-to-severe depression, as confirmed by Beck Depression Inventory (BDI-II) total score >28.
- Patients with a history (within 2 years prior to the Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment
- Patients unlikely to be cooperative or that can't comply with the study procedures.
- Patients treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to the Screening Visit
- Patients who intends to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication
- Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Aclidinium bromide
Aclidinium bromide 400 μg administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).
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Altri nomi:
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Comparatore placebo: Placebo
Placebo administered via oral inhalation (Genuair® dry powder inhaler) one inhalation twice daily (12 hours apart, morning and evening).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Morning Trough FEV1
Lasso di tempo: Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Peak FEV1
Lasso di tempo: Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Normalized FEV1 AUC0-12hr
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment
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0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment
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Change From Baseline in Normalized FEV1 AUC12-24hr
Lasso di tempo: 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity
Lasso di tempo: Week 3 of treatment
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Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity
Lasso di tempo: Week 3 of treatment
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The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime.
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity
Lasso di tempo: Week 3 of treatment
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Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities
Lasso di tempo: Week 3 of treatment
|
Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI].
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]).
Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms
|
Week 3 of treatment
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Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities
Lasso di tempo: Week 3 of treatment
|
The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime.
Scores ranged from 0 (no symptoms) to 4 (very severe symptoms).
Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms
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Week 3 of treatment
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Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time
Lasso di tempo: Week 3 of treatment
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The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea.
The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep
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Week 3 of treatment
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Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time
Lasso di tempo: Week 3 of treatment
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The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
In this study, any event with a 4% decrease in blood oxygen levels counted towards the total
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Week 3 of treatment
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Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time
Lasso di tempo: Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Sleep Efficiency
Lasso di tempo: Week 3 of treatment
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Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed
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Week 3 of treatment
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Change From Baseline in Total Sleep Time
Lasso di tempo: Week 3 of treatment
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Week 3 of treatment
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Change From Baseline in Duration of at Least Moderate Activity
Lasso di tempo: Week 3 of treatment
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Moderate activity was defined as any physical activity >3 metabolic equivalents
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Week 3 of treatment
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Change From Baseline in Number of Steps Per Day
Lasso di tempo: Week 3 of treatment
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Week 3 of treatment
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Anna Ribera, PhD, AstraZeneca Barcelona
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2014
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2015
Date di iscrizione allo studio
Primo inviato
5 maggio 2014
Primo inviato che soddisfa i criteri di controllo qualità
30 maggio 2014
Primo Inserito (Stima)
3 giugno 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
9 novembre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 settembre 2016
Ultimo verificato
1 settembre 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M/34273/47
- 2013-003373-10 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .