COPDPhase 4NCT01377051
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
A Phase 4 study testing Indacaterol maleate in people with COPD and Lung Diseases, run by University of Milan at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- COPD, Lung Diseases, Dyspnea
- What is being tested?
- Indacaterol maleate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Sep 2011
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of consensus
- COPD diagnosis
- Age from 50 to 85 years old
- history of COPD at least of one year
- respiratory stable conditions at least of one month
- Any basal FEV1 expressed in % of predicted value
- FEV1/ Forced Vital Capacity (FVC) less than 70%
- Former or active smokers with at least a smoking history of 20 pack year
Who cannot join
- Pregnancy
- FEV1/FVC more than 70%
- Known deficit of alpha 1 antitrypsin
- Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
- Subjects with known positivity to Human Immunodeficiency Virus (HIV)
- Misuse of alcool or drugs
- Absence of compliance in performing respiratory tests
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS
Milan, 20138
About this study
Official title: Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.
The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.
Read the detailed description
Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.
Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.
- Conditions
- COPD, Lung Diseases, Dyspnea, Hypoxemia, Tachycardia
- Being tested
- Indacaterol maleate, Placebo
- Keywords
- COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Dyspnea, Hypoxia, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol maleateDrug
Also called Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Dry powered, 300 mcg, only one inhalation with 24 hours duration
PlaceboDrug
Dry powered, same to study drug, only one inhalation
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilator | Active comparator | Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list. Receives: Drug: Indacaterol maleate |
| Placebo | Placebo comparator | Will be administered with the same device by a third independent investigator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Thoracic Gas Volume (ITGV)
A complete body plethysmografic test will be performed after indacaterol inhalation
Measured: 60 minutes after drug inhalation
Secondary outcomes (2)
Forced Expired Volume in the first second (FEV1)
Will be performed: spirometry, Arterial blood sample, measurement of blood pressure and cardiac frequency. All these parameters will be tested 60 minutes after inhalation of Indacaterol 300 micrograms (mcg).
Measured: 60 minutes after drug inhalation
Partial pressure of arterial oxygen (PaO2)
Arterial gas analysis will be performed evaluating all arterial gases
Measured: 60 minutes after drug inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Responsible party
- Principal investigator, Pierachille Santus, University of Milan
- Investigators
- Pierachille Santus, MD, PhD, Study director, Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377051
- Sponsor's protocol ID
- 654CEC
- Status last verified
- Oct 2014
- First submitted
- 15 Jun 2011
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.
- ClinicalTrials.gov ID
- NCT01377051
- Acronym / sponsor ID
- 654CEC
- Conditions
- COPD, Lung Diseases, Dyspnea, Hypoxemia, Tachycardia
- Keywords
- COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jun 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.
The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.
Detailed description
Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.
Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bronchodilator | Active comparator | Drug: Indacaterol maleateIndacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list. |
| Placebo | Placebo comparator | Drug: PlaceboWill be administered with the same device by a third independent investigator |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signature of consensus
- COPD diagnosis
- Age from 50 to 85 years old
- history of COPD at least of one year
- respiratory stable conditions at least of one month
Key exclusion criteria (7 listed)
- Pregnancy
- FEV1/FVC more than 70%
- Known deficit of alpha 1 antitrypsin
- Subjects submitted to a Lung Volume Reduction Surgery (LVRS)
- Subjects with known positivity to Human Immunodeficiency Virus (HIV)
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 |
|---|---|---|
| Indacaterol maleateAlso: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, ArcaptaDry powered, 300 mcg, only one inhalation with 24 hours duration | Drug | Bronchodilator |
| PlaceboDry powered, same to study drug, only one inhalation | Drug | Placebo |
Primary outcome
Intra Thoracic Gas Volume (ITGV)
Time frame: 60 minutes after drug inhalation
A complete body plethysmografic test will be performed after indacaterol inhalation
2 secondary outcomes
Forced Expired Volume in the first second (FEV1)
Time frame: 60 minutes after drug inhalation
Partial pressure of arterial oxygen (PaO2)
Time frame: 60 minutes after drug inhalation
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 29 Oct 2014.
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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.
Pierachille Santus, MD, PhD study director
Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it
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 Indacaterol maleate in people with COPD and Lung Diseases, run by University of Milan at 1 site in Italy.
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 8 inclusion and 7 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 29 Oct 2014. 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 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?
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?
Intra Thoracic Gas Volume (ITGV) (time frame: 60 minutes after drug inhalation). 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 29 Oct 2014.