Pulmonary Disease, Chronic ObstructivePhase 4M-34273-46NCT02375724
BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
A Phase 4 study testing Aclidinium Bromide in people with Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 24 sites in 5 countries.
Trial summary
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this… Read more about this study
- Who is it for?
- Ages 40 to 110 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Aclidinium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Mar 2015to Nov 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
- Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
- Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and <80% and FEV1/FVC <70%.
- Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
- Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum production for at least 3 months in each of 2 consecutive years")
- Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained
Who cannot join
- History or current diagnosis of asthma.
- Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
- Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
- Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
- Patient who in the investigator's opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
- Use of long-term oxygen therapy.
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- Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
- Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
- Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
- Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
- Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
- Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
- Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
- Current diagnosis of cancer other than basal or squamous cell skin cancer
- Patient with any other serious or uncontrolled physical or mental dysfunction
- Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.
- Patient unlikely to be cooperative or that can not comply with the study procedures
- Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
- Patient who intend 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Spain7 sites
Research Site
Alicante
Research Site
Barcelona
Research Site
Hospitalet de Llobregat(Barcel
Research Site
Laredo
Research Site
Madrid
Research Site
Santiago(A Coruña)
Research Site
Seville
Germany6 sites
Research Site
Berlin
Research Site
Dortmund
Research Site
Frankfurt
Research Site
Frankfurt am Main
Research Site
Hanover
Research Site
Lübeck
Hungary6 sites
Research Site
Balassagyarmat
Research Site
Debrecen
Research Site
Komárom
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Százhalombatta
United Kingdom3 sites
Research Site
Manchester
Research Site
Northwood
Research Site
Sidcup
About this study
Official title: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Aclidinium Bromide, Placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aclidinium BromideDrug
Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
PlaceboDrug
Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium Bromide 400 μg | Experimental | Aclidinium Bromide 400 μg twice daily by inhalation Receives: Drug: Aclidinium Bromide |
| Placebo | Placebo comparator | placebo twice daily by inhalation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period
The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms
Measured: Baseline to Week 8
Secondary outcomes (2)
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period
The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms
Measured: Baseline to Week 8
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8
The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Menarini Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375724
- Sponsor's protocol ID
- D6560C00001
- Other IDs
- 2014-004715-37, M-34273-46, 2014
- Acronym
- M-34273-46
- Status last verified
- Feb 2017
- First submitted
- 26 Feb 2015
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD
- ClinicalTrials.gov ID
- NCT02375724
- Acronym / sponsor ID
- M-34273-46 / D6560C00001
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Menarini Group
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID compared with placebo on COPD symptoms in a symptomatic patients population with moderate COPD and chronic bronchitis, and particularly assess the effects in cough by using specific tools to assess the occurrence and impact of this relevant COPD symptom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aclidinium Bromide 400 μg | Experimental | Drug: Aclidinium BromideAclidinium Bromide 400 μg twice daily by inhalation |
| Placebo | Placebo comparator | Drug: Placeboplacebo twice daily by inhalation |
Who may qualify
- Ages
- 40 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
- Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
- Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and <80% and FEV1/FVC <70%.
- Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
- Clinical Diagnosis of Chronic Bronchitis (defined as "presence of cough and sputum production for at least 3 months in each of 2 consecutive years")
Key exclusion criteria (20 listed)
- History or current diagnosis of asthma.
- Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
- Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
- Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
- Patient who in the investigator's opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aclidinium BromideInhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler | Drug | Aclidinium Bromide 400 μg |
| PlaceboInhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler | Drug | Placebo |
Primary outcome
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period
Time frame: Baseline to Week 8
The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms
2 secondary outcomes
Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period
Time frame: Baseline to Week 8
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aclidinium Bromide in people with Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain, Germany, Hungary, United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.