Pulmonary Disease, Chronic ObstructivePhase 4ImperialNCT01344655
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
A Phase 4 study testing Atimos® and Serevent™ in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Atimos® and Serevent™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Sep 2012
- Phase
- Phase 4
- 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
- Patients with a clinical diagnosis of COPD
- Post bronchodilator FEV1 between 30% and 80% predicted values at screening
- Post-bronchodilator FEV1/FVC < 0.7
Who cannot join
- Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
- History of another medical condition contraindicating participation in the study
- Clinical evidence of heart failure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Airway Disease Section, NHLI, Imperial College London
London, SW3 6LY
About this study
Official title: A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients
This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.
Read the detailed description
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Atimos®, Serevent™, Placebo
- 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.
Atimos®Drug
Formoterol 12 μg pMDI
Serevent™Drug
Salmeterol 25 µg pMDI
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Formoterol 12 μg pMDI (Atimos®) | Experimental | Not described Receives: Drug: Atimos® |
| Salmeterol 25 µg pMDI HFA (Serevent™) | Active comparator | Not described Receives: Drug: Serevent™ |
| Matched Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Impedance by Impulse oscillometry
Measured: from 5 minutes to 8 hours post dose
Secondary outcomes (3)
Exhaled Nitric Oxide
Measured: from 30 minutes to 8 hours post dose
Multiple Breath Nitrogen Washout
Measured: from 30 minutes to 8 hours post dose
Forced Expiratory Volume in the 1st second
Measured: from 30 minutes to 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omar S Usmani, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344655
- Sponsor's protocol ID
- CCD-0901-PR-0012
- Other IDs
- 2008-008656-16, 2008
- Acronym
- Imperial
- Status last verified
- Mar 2017
- First submitted
- 29 Nov 2010
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients
- ClinicalTrials.gov ID
- NCT01344655
- Acronym / sponsor ID
- Imperial / CCD-0901-PR-0012
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Apr 2011 (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 is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.
Detailed description
A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formoterol 12 μg pMDI (Atimos®) | Experimental | Drug: Atimos® |
| Salmeterol 25 µg pMDI HFA (Serevent™) | Active comparator | Drug: Serevent™ |
| Matched Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of COPD
- Post bronchodilator FEV1 between 30% and 80% predicted values at screening
- Post-bronchodilator FEV1/FVC < 0.7
Key exclusion criteria (3 listed)
- Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
- History of another medical condition contraindicating participation in the study
- Clinical evidence of heart failure
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 |
|---|---|---|
| Atimos®Formoterol 12 μg pMDI | Drug | Formoterol 12 μg pMDI (Atimos®) |
| Serevent™Salmeterol 25 µg pMDI | Drug | Salmeterol 25 µg pMDI HFA (Serevent™) |
| Placeboplacebo | Drug | Matched Placebo |
Primary outcome
Respiratory Impedance by Impulse oscillometry
Time frame: from 5 minutes to 8 hours post dose
3 secondary outcomes
Exhaled Nitric Oxide
Time frame: from 30 minutes to 8 hours post dose
Multiple Breath Nitrogen Washout
Time frame: from 30 minutes to 8 hours post dose
Forced Expiratory Volume in the 1st second
Time frame: from 30 minutes to 8 hours post dose
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 30 Mar 2017.
- Study Record on EU Clinical Trials Register including resultsLink 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.
Omar S Usmani, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atimos® and Serevent™ in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. 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 3 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 30 Mar 2017. 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 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?
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?
Respiratory Impedance by Impulse oscillometry (time frame: from 5 minutes to 8 hours post dose). 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 30 Mar 2017.