COPDPhase 4ULT01NCT02576626
Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD
A Phase 4 study testing indacaterol/glycopyrronium 110/50 Breezhaler® and ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation in people with COPD, run by Wouter H. van Geffen at 1 site in Netherlands.
Trial summary
Rationale: Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and wet nebulizers. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- indacaterol/glycopyrronium 110/50 Breezhaler® and ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to 29 Sep 2017
- 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
- COPD, post-bronchodilator FEV1/FVC < 70%; post-br FEV1 < 80%pred
- Active mastery of Dutch
- Written informed consent
- At least 40 years old
- Participants must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch
Who cannot join
- Non invasive ventilation
- Saturation by pulse oxymetry <88%
- Documented history of asthma
- Instable cardiac disease within 6 months.
- Known long corrected QT interval (QTC) syndrome
- Known estimated Glomerular Filtration Rate (EGFR) ( <30 ml/min *1,73m2
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- Exacerbations of COPD or change of medication for COPD in the last 6 weeks prior to inclusion
- Allergic reaction or intolerance for a substance used in one of the products or atropine or atropine derived substances
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Single Dose Ultibro Breezhaler (Indacaterol/Glycopyrronium) by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in Improving FEV1 and Dyspnea During Stable State of COPD
Rationale:
Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is cumbersome, and, importantly, has never been scientifically been proven to be more efficacious than delivery by the other two methods. Yet many patients are happy with wet nebulization and in many clinics this administration method prevails. The investigators believe that combined long-acting bronchodilators, are more efficacious than combined short acting bronchodilators per nebulizers.
Read more
Objective:
To test the hypothesis that: The combination of the two long-acting bronchodilators indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement compared to nebulisation with ipratropium/salbutamol, when administered as single dose in patients with stable state chronic obstructive pulmonary disease (COPD).
Study design: Investigator initiated, randomised, active controlled, cross-over double-blind (and therefore double-dummy), study comparing the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state Study population: Patients visiting the outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred. Intervention The investigators will compare the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state
Main study parameters/endpoints:
Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study has no specific benefits for the participating patients. The study also has no major risks. Minor risks for participants after a single dosis can be throat irritation, cough, headache and dizziness, sinus tachycardia. The combination of treatments with β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily practice for many years in many countries and they are often prescribed both in COPD. Both indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the Netherlands
- Conditions
- COPD
- Being tested
- indacaterol/glycopyrronium 110/50 Breezhaler®, Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation
- Keywords
- Nebulizer, DPI, COPD, indacaterol, ipratropium, glycopyrronium, salbutamol, Breezhaler, Nebuliser, Hyperinflation, Dyspnea, SABA, short-acting muscarinic antagonists (SAMA), long-acting beta2-agonist (LABA), LAMA, FEV1
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indacaterol/glycopyrronium 110/50 Breezhaler®Drug
Also called Ultibro
Placebo by Breezhaler®Device
ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisationDrug
Also called Combivent
Placebo by nebulisationDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Participants start with Ultibro (indacaterol/glycopyrronium 110/50) + placebo nebulization , then after a new washout period of 7 days they will receive ipratropium/salbutamol nebulization and placebo Breezhaler Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation Receives: Drug: indacaterol/glycopyrronium 110/50 Breezhaler®; Device: Placebo by Breezhaler®; Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation; Device: Placebo by nebulisation |
| B | Other | Participants start with ipratropium/salbutamol nebulization and placebo Breezhaler , then after a new washout period of 7 days they will receive Ultibro(indacaterol/glycopyrronium 110/50) + placebo nebulization.
Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation Receives: Drug: indacaterol/glycopyrronium 110/50 Breezhaler®; Device: Placebo by Breezhaler®; Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation; Device: Placebo by nebulisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of FEV1
Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol.
Measured: from 0 to 6 hours
Secondary outcomes (8)
Change in Borg dyspnea score at 30 min
- Change in Borg dyspnea score at 30 min: change in Borg score at other time points
Measured: 30 min up to 360 minutes
Proportion of patients reaching the minimal clinically important difference (MCID) at all time points
proportion of patients reaching the MCID at all time points (15, 30, 60, 120 240 and 360 min) (1)
Measured: all time points (15, 30, 60, 120 240 and 360 min)
Changes in level of hyperinflation (by IC measurement)
Measured: all time points (15, 30, 60, 120 240 and 360 min)
Time to FEV1 increase of 100 ml
Measured: all time points (15, 30, 60, 120 240 and 360 min)
Peak effect of FEV1
Maximum FEV1 per group, calculated using the best FEV1 per participant
Measured: from 0 to 6 hours
Time to peak of FEV1
Measured: all time points (15, 30, 60, 120 240 and 360 min)
FEV1
Measured: at all time points (15, 30, 60, 120 240 and 360 min)
Proportion of participants reaching a difference of 100 ml of inspiratory capacity (IC)
Measured: Time Frame: all time points (15, 30, 60, 120 240 and 360 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wouter H. van Geffen
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, University Medical Center Groningen
- Responsible party
- Sponsor-investigator, Wouter H. van Geffen, Groningen Research Institute for Asthma and COPD
- Investigators
- Huib AM Kerstjens, prof. dr., Principal investigator, Groningen Research Institute for Asthma and COPDWouter H van Geffen, MD, Study director, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576626
- Sponsor's protocol ID
- NL5250604215
- Acronym
- ULT01
- Status last verified
- Oct 2017
- First submitted
- 4 Aug 2015
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single Dose Ultibro Breezhaler (Indacaterol/Glycopyrronium) by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in Improving FEV1 and Dyspnea During Stable State of COPD
- ClinicalTrials.gov ID
- NCT02576626
- Acronym / sponsor ID
- ULT01 / NL5250604215
- Conditions
- COPD
- Keywords
- Nebulizer, DPI, COPD, indacaterol, ipratropium, glycopyrronium, salbutamol, Breezhaler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wouter H. van GeffenUniversity, hospital or other
- Collaborators
- Novartis, University Medical Center Groningen
- Study start
- Dec 2015
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 15 Oct 2015 (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.
Rationale:
Inhaled bronchodilators, beta-2-agonist or anticholinergic or combinations, can be delivered by several types of devices: dry powder (DPI), pressurized metered dose inhalers (pMDI), and wet nebulizers. Wet nebulization is available for short-acting bronchodilators only, is cumbersome, and, importantly, has never been scientifically been proven to be more efficacious than delivery by the other two methods. Yet many patients are happy with wet nebulization and in many clinics this administration method prevails. The investigators believe that combined long-acting bronchodilators, are more efficacious than combined short acting bronchodilators per nebulizers.
Objective:
To test the hypothesis that: The combination of the two long-acting bronchodilators indacaterol and glycopyrronium by dry powder inhalation confers a superior improvement compared to nebulisation with ipratropium/salbutamol, when administered as single dose in patients with stable state chronic obstructive pulmonary disease (COPD).
Study design: Investigator initiated, randomised, active controlled, cross-over double-blind (and therefore double-dummy), study comparing the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state Study population: Patients visiting the outpatient clinics or from general practitioner (GP) practices with COPD GOLD stage A-D, and (FEV1) post-bronchodilator FEV1/ forced vital capacity (FVC) < 70%; post-br FEV1 < 80%pred. Intervention The investigators will compare the effects of single dose indacaterol/glycopyrronium 110/50 Breezhaler® versus single dose ipratropium/salbutamol nebulisation in patients with COPD in stable state
Main study parameters/endpoints:
Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study has no specific benefits for the participating patients. The study also has no major risks. Minor risks for participants after a single dosis can be throat irritation, cough, headache and dizziness, sinus tachycardia. The combination of treatments with β2-agonist bronchodilators and anticholinergic bronchodilators have been used in daily practice for many years in many countries and they are often prescribed both in COPD. Both indacaterol/glycopyrronium and ipratropium/salbutamol are approved for COPD treatment in the Netherlands
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: indacaterol/glycopyrronium 110/50 Breezhaler®, Device: Placebo by Breezhaler®, Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Device: Placebo by nebulisationParticipants start with Ultibro (indacaterol/glycopyrronium 110/50) + placebo nebulization , then after a new washout period of 7 days they will receive ipratropium/salbutamol nebulization and placebo Breezhaler Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation |
| B | Other | Drug: indacaterol/glycopyrronium 110/50 Breezhaler®, Device: Placebo by Breezhaler®, Drug: ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Device: Placebo by nebulisationParticipants start with ipratropium/salbutamol nebulization and placebo Breezhaler , then after a new washout period of 7 days they will receive Ultibro(indacaterol/glycopyrronium 110/50) + placebo nebulization. Interventions: indacaterol/glycopyrronium 110/50 Breezhaler® ,Placebo by Breezhaler®, ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation, Placebo by nebulisation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD, post-bronchodilator FEV1/FVC < 70%; post-br FEV1 < 80%pred
- Active mastery of Dutch
- Written informed consent
- At least 40 years old
- Participants must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch
Key exclusion criteria (9 listed)
- Non invasive ventilation
- Saturation by pulse oxymetry <88%
- Documented history of asthma
- Instable cardiac disease within 6 months.
- Known long corrected QT interval (QTC) syndrome
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/glycopyrronium 110/50 Breezhaler®Also: Ultibro | Drug | A, B |
| Placebo by Breezhaler® | Device | A, B |
| ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisationAlso: Combivent | Drug | A, B |
| Placebo by nebulisation | Device | A, B |
Primary outcome
Area under the curve (AUC) of FEV1
Time frame: from 0 to 6 hours
Area under the curve (AUC) from 0 to 6 hours of FEV1 with indacaterol and glycopyrronium, compared to nebulisation with ipratropium/salbutamol.
8 secondary outcomes
Change in Borg dyspnea score at 30 min
Time frame: 30 min up to 360 minutes
Proportion of patients reaching the minimal clinically important difference (MCID) at all time points
Time frame: all time points (15, 30, 60, 120 240 and 360 min)
Changes in level of hyperinflation (by IC measurement)
Time frame: all time points (15, 30, 60, 120 240 and 360 min)
Time to FEV1 increase of 100 ml
Time frame: all time points (15, 30, 60, 120 240 and 360 min)
Peak effect of FEV1
Time frame: from 0 to 6 hours
Time to peak of FEV1
Time frame: all time points (15, 30, 60, 120 240 and 360 min)
FEV1
Time frame: at all time points (15, 30, 60, 120 240 and 360 min)
Proportion of participants reaching a difference of 100 ml of inspiratory capacity (IC)
Time frame: Time Frame: all time points (15, 30, 60, 120 240 and 360 min)
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 11 Oct 2017.
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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.
Huib AM Kerstjens, prof. dr. principal investigator
Groningen Research Institute for Asthma and COPD
Wouter H van Geffen, MD study director
Frisius Medisch Centrum
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/glycopyrronium 110/50 Breezhaler® and ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation in people with COPD, run by Wouter H. van Geffen at 1 site in Netherlands.
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 5 inclusion and 9 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 11 Oct 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 Netherlands. 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 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?
Area under the curve (AUC) of FEV1 (time frame: from 0 to 6 hours). 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 11 Oct 2017.