Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00435760
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study testing Aclidinium bromide and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Aclidinium bromide and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2007to Aug 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥ 40 years
- Current or ex-smokers of ≥ 10 pack-year
- Clinical diagnosis of severe stable COPD
Who cannot join
- History or current diagnosis of asthma, allergic rhinitis, or atopy
- Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
- Hospitalised for an acute COPD exacerbation in the last 3 months
- Evidence of contraindicated use of anticholinergic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.
Read the detailed description
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
- Being tested
- Aclidinium bromide, Placebo Tiotropium, Tiotropium, Placebo LAS34273
- 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
200 micrograms, once daily, 1 day treatment
Placebo TiotropiumDrug
1 puff once daily, 1 day treatment
TiotropiumDrug
1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00
Placebo LAS34273Drug
1 puff, 1 dat treatment
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Active comparator | 1 puff, 1 day treatment Receives: Drug: Tiotropium |
| Placebo | Placebo comparator | Tiotropium or Aclidinium Placebo, 1 day treatment Receives: Drug: Placebo Tiotropium; Drug: Placebo LAS34273 |
| Aclidinium bromide | Experimental | 200 micrograms, once daily, 1 day treatment Receives: Drug: Aclidinium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 Percentage Increase
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
Measured: 30 minutes
Secondary outcomes (1)
Normalised Area FEV1 AUC 0-3h
Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min
Measured: 0-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Garcia, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435760
- Sponsor's protocol ID
- M/34273/24
- Other IDs
- 2005-005804-17, 2005
- Status last verified
- Nov 2016
- First submitted
- 14 Feb 2007
- Last updated
- 17 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00435760
- Acronym / sponsor ID
- M/34273/24
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.
Detailed description
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Active comparator | Drug: Tiotropium1 puff, 1 day treatment |
| Placebo | Placebo comparator | Drug: Placebo Tiotropium, Drug: Placebo LAS34273Tiotropium or Aclidinium Placebo, 1 day treatment |
| Aclidinium bromide | Experimental | Drug: Aclidinium bromide200 micrograms, once daily, 1 day treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged ≥ 40 years
- Current or ex-smokers of ≥ 10 pack-year
- Clinical diagnosis of severe stable COPD
Key exclusion criteria (4 listed)
- History or current diagnosis of asthma, allergic rhinitis, or atopy
- Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
- Hospitalised for an acute COPD exacerbation in the last 3 months
- Evidence of contraindicated use of anticholinergic drugs
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 bromide200 micrograms, once daily, 1 day treatment | Drug | Aclidinium bromide |
| Placebo Tiotropium1 puff once daily, 1 day treatment | Drug | Placebo |
| Tiotropium1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00 | Drug | Tiotropium |
| Placebo LAS342731 puff, 1 dat treatment | Drug | Placebo |
Primary outcome
FEV1 Percentage Increase
Time frame: 30 minutes
Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes
1 secondary outcome
Normalised Area FEV1 AUC 0-3h
Time frame: 0-3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Sponsor web siteLink provided by the sponsor.
- Co-Sponsor web siteLink provided by the sponsor.
- CSR SynopsisLink provided by the sponsor.
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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.
Esther Garcia, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aclidinium bromide and Tiotropium in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United Kingdom.
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 3 inclusion and 4 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FEV1 Percentage Increase (time frame: 30 minutes). 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 17 Nov 2016.