Clinical trial NCT03181880: To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease
Official title: To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: ASTUTE
Chronic Obstructive Pulmonary Disease
Randomised
Pragmatic
Standard of Care
Aclidinium bromide/formoterol fumarate fixed-dose combination
Duaklir
Genuair
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: QuintilesIMS, Inc.
First posted: 2017-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.

Detailed description: ASTUTE is a longitudinal, randomised, multicentre, and multinational pragmatic study of patients with Chronic Obstructive Pulmonary Disease to evaluate the comparative effectiveness of Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®) and Standard of Care bronchodilators in patients treated with long acting bronchodilator monotherapies OR patients who abide to the following treatment category: patient is newly diagnosed, or naïve to maintenance therapy, or treated with short-acting bronchodilators as rescue medication, or has not been treated with long-acting bronchodilators in the last 3 months.

Eligibility criteria: Inclusion Criteria:

Patient is aged 40 years or older;

* Confirmed diagnosis of COPD;
* Spirometry performed at study entry or within the last 3 months preceding study entry with a post-bronchodilator Forced Expiratory Volume in 1 Second/Forced Vital Capacity quotient less than 0.7;
* Patient is a current smoker or an ex-smoker with a smoking history of ≥10 pack-years;
* Patient belongs to any of these treatment groups:

  * Patient is treated by a monotherapy long-acting bronchodilator (Long-Acting Muscarinic Antagonist or Long-Acting Beta Agonist), or
  * Naïve COPD patient, defined as:
* Patient is newly diagnosed, or
* Patient is naïve to maintenance therapy, or
* Patient is treated with short acting bronchodilators as rescue medication, or
* Patient has not been treated with long acting bronchodilators in the last 3 months.

Exclusion Criteria:

-

Patients should not be included in the study if any of the following exclusion criteria applies:

* Patient changed COPD treatment regimen over the preceding 3 months;
* Patient treated or intended to be treated at the time of randomisation with a maintenance regimen of inhaled corticosteroids or inhaled corticosteroids-containing medications;
* Patient treated or intended to be treated at the time of randomisation with aclidinium bromide/formoterol fumarate dihydrate inhalation powder;
* Patient had a previous diagnosis of asthma or is suspected of having asthma, asthma-COPD overlap or any other chronic respiratory disease other than COPD (including severe ones, such as cystic fibrosis, pulmonary fibrosis, active neoplasm except adequately treated \[no evidence of recurrence within 5 years\], active tuberculosis);
* Patient developed a respiratory tract infection or COPD exacerbation within 6 weeks (or 3 months if an exacerbation-related hospitalisation was required) before the randomisation visit;
* Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, lactose monohydrate, inhaled medication, or any component thereof (including report of paradoxical bronchospasm);
* Patient has been previously enrolled in the current study.
* Any condition that in the Investigator's opinion, would limit a patient's ability to participate in the study.

Primary outcomes:
measure: Change from baseline in overall early morning COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Early Morning Symptoms of COPD Instrument over 12 wks.
timeFrame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
measure: Change from baseline in overall night time COPD symptom severity score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder vs. Standard of Care bronchodilators as measured by the Nighttime Symptoms of COPD Instrument over 12 weeks.
timeFrame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
Secondary outcomes:
measure: Change from baseline in daily RS total Score of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the E-RS™COPD scale over 12 weeks.
timeFrame: study entry and previous day (retrospectively), days 22-28, days 50-56, days 78-84
measure: Change from baseline in health status of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilatorsmeasured by the COPD assessment Test (CAT) over 12 weeks.
timeFrame: study entry, days 28, 56 and 84
measure: Change from baseline in total time index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
timeFrame: study entry, days 28, 56 and 84
measure: Change from baseline in Energy Expenditure Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
timeFrame: study entry, days 28, 56 and 84
measure: Change from baseline in Activity Dimensions Summary Index of aclidinium bromide/formoterol fumarate dihydrate inhalation powder versus Standard of Care bronchodilators measured by the Yale Physical Activity Survey (YPAS) over 12 weeks.
timeFrame: study entry, days 28, 56 and 84
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Anna Ribera
role: STUDY_DIRECTOR
References: