Chronic Obstructive Pulmonary DiseasePhase 2NCT01048333
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
A Phase 2 study testing Formoterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 17 sites in 3 countries.
Trial summary
Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Formoterol and Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
- A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
- Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.
Who cannot join
- A history and/or current diagnosis of asthma.
- Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
- A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Italy10 sites
Research Site
Bussolengo
Research Site
Cassano delle Murge
Research Site
Catanzaro
Research Site
Cava de' Tirreni
Research Site
Naples
Research Site
Palermo
Research Site
Parma
Research Site
Pisa
Research Site
Prato
Research Site
Roma
Sweden4 sites
Research Site
Gothenburg
Research Site
Linköping
Research Site
Luleå
Research Site
Lund
About this study
Official title: A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.
- Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
- Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Formoterol, Salmeterol, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, Onset of effect, COPD, Oxis Turbuhaler
- 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.
FormoterolDrug
Formoterol Turbuhaler 9 μg and Placebo Diskus
SalmeterolDrug
Salmeterol Diskus 50 μg and Placebo Turbuhaler
PlaceboDrug
Placebo Diskus and Placebo Turbuhaler
| Study group | Role | What they receive |
|---|---|---|
| Formoterol, then Salmeterol, then Placebo | Experimental | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
| Salmeterol, then Palcebo, then Formoterol | Experimental | Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
| Placebo, then Formoterol, then Salmeterol | Experimental | Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
| Formoterol, then Placebo, then Salmeterol | Experimental | Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
| Salmeterol, then Formoterol, then Placebo | Experimental | Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
| Placebo, then Salmeterol, then Formoterol | Experimental | Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus Receives: Drug: Formoterol; Drug: Salmeterol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Measured: Pre-dose and 5 minutes post-dose
Secondary outcomes (4)
Average FEV1 During the First 15 Minutes Post Dose
Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Measured: Pre dose and 15 minutes post dose
Average FEV1 During 120 Minutes Post Dose
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Measured: Pre dose and 120 minutes post dose
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1
Measured: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
Adverse Events
Number of participants with at least 1 AE.
Measured: At baseline and at each day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Cazzola, professor, Principal investigator, ItalyGeorgios Stratelis, Study director, AstraZeneca MC Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048333
- Sponsor's protocol ID
- D5127C00001
- Status last verified
- Sep 2012
- First submitted
- 12 Jan 2010
- Last updated
- 25 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.
PubMed 22235841
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.
- ClinicalTrials.gov ID
- NCT01048333
- Acronym / sponsor ID
- D5127C00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Onset of effect, COPD, Oxis Turbuhaler
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Posted 25 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
- Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Formoterol, then Salmeterol, then Placebo | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboFormoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler |
| Salmeterol, then Palcebo, then Formoterol | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboSalmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
| Placebo, then Formoterol, then Salmeterol | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboPlacebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| Formoterol, then Placebo, then Salmeterol | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboFormoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler |
| Salmeterol, then Formoterol, then Placebo | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboSalmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler |
| Placebo, then Salmeterol, then Formoterol | Experimental | Drug: Formoterol, Drug: Salmeterol, Drug: PlaceboPlacebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
- A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
- Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.
Key exclusion criteria (3 listed)
- A history and/or current diagnosis of asthma.
- Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
- A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.
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 |
|---|---|---|
| FormoterolFormoterol Turbuhaler 9 μg and Placebo Diskus | Drug | Formoterol, then Placebo, then Salmeterol, Formoterol, then Salmeterol, then Placebo, Placebo, then Formoterol, then Salmeterol, Placebo, then Salmeterol, then Formoterol, Salmeterol, then Formoterol, then Placebo, Salmeterol, then Palcebo, then Formoterol |
| SalmeterolSalmeterol Diskus 50 μg and Placebo Turbuhaler | Drug | Formoterol, then Placebo, then Salmeterol, Formoterol, then Salmeterol, then Placebo, Placebo, then Formoterol, then Salmeterol, Placebo, then Salmeterol, then Formoterol, Salmeterol, then Formoterol, then Placebo, Salmeterol, then Palcebo, then Formoterol |
| PlaceboPlacebo Diskus and Placebo Turbuhaler | Drug | Formoterol, then Placebo, then Salmeterol, Formoterol, then Salmeterol, then Placebo, Placebo, then Formoterol, then Salmeterol, Placebo, then Salmeterol, then Formoterol, Salmeterol, then Formoterol, then Placebo, Salmeterol, then Palcebo, then Formoterol |
Primary outcome
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
Time frame: Pre-dose and 5 minutes post-dose
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
4 secondary outcomes
Average FEV1 During the First 15 Minutes Post Dose
Time frame: Pre dose and 15 minutes post dose
Average FEV1 During 120 Minutes Post Dose
Time frame: Pre dose and 120 minutes post dose
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Time frame: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
Adverse Events
Time frame: At baseline and at each day of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22235841Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Mario Cazzola, professor principal investigator
Italy
Georgios Stratelis study director
AstraZeneca MC Sweden
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formoterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 17 sites in 3 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 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy, Sweden, Spain. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Oct 2012). 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?
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose (time frame: Pre-dose and 5 minutes post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048333, which also lists 1 linked publication.
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 25 Oct 2012.