Pulmonary Disease, Chronic Obstructive (COPD)Phase 4NCT02596009
Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices
A Phase 4 study testing Breezhaler®, Ellipta® and Handihaler® in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Novartis Pharmaceuticals at 5 sites in Argentina.
Trial summary
The purpose of this study was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were administered to patients in this study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (COPD)
- What is being tested?
- Breezhaler®, Ellipta® and Handihaler®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 5 sitesArgentina
- Study dates
- 16 Dec 2015to 29 Apr 2016
- Phase
- Phase 4
- 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
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
- Note: A pack of cigarettes is equal to 20 cigarettes. Occasional smoking of cigars is not relevant to smoking history.
- An ex-smoker is defined as a patient who has not smoked for ≥6 months at screening.
- COPD patients with moderate to very severe airflow limitation (spirometric classification: GOLD 2, 3 or 4) at time of screening,
- Post-bronchodilator FEV1 < 80% of the predicted normal, and
- Post-bronchodilator FEV1/forced vital capacity (FVC) <0.70. (Post-bronchodilator refers to 1 hour after sequential inhalation of 84 µg ipratropium bromide and 400 µg salbutamol)
- Willing patients assessed as suitable by investigator to reproducibly perform inhalational manoeuvers through study devices as required by the standard protocol
- Willing patients assessed as suitable by investigator to comprehend and follow the instructions for use of the inhalational devices to be tested in the study
Who cannot join
- Patients with a history of asthma or onset of respiratory symptoms prior to the age of 40 years
- Use of short acting bronchodilating agent (SABA) as rescue (reliever) medication within 6 hours prior to or during inhalational profile assessments for the study [Note: Use of rescue medication should not be restricted if patient feels the need of the rescue/ reliever medication because of the diseased state. Safety and disease management should be priority and the suitability of such a patient for the study or relevance of the (study) assessments done for the study should be reviewed, as appropriate.]
- Patients with any history of premature birth less than 33 weeks gestation or significant level of respiratory care including mechanical ventilation required as neonate affecting the respiratory tract or chronic lung diseases, which in the opinion of the investigator or designated study personnel at site may interfere with the study evaluation or optimal participation in the study.
- Any major chronic illness including but not limited to a diagnosis of non-skin cancer, cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder).
- Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening
- Patients who, within 7 days prior to the screening visit (Visit 1) OR prior to Visit 2, increased use of rescue bronchodilators amounting to more than double the average number of puffs used in the preceding week or more than 8 puffs of SABA on any 3 consecutive days or more than 12 puffs of SABA on any 2 consecutive days
- Respiratory tract infections (sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection) within the 4weeks before the visit
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Argentina5 sites
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1425FVH
Novartis Investigative Site
Florida, Buenos Aires, B1602DQD
Novartis Investigative Site
La Plata, Buenos Aires, 1900
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Multicenter Open-label Cross-over Study to Compare Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Dry Powder Inhaler Devices
The purpose of this study was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were administered to patients in this study.
Read the detailed description
The inspiratory flow rates achieved by the COPD patients, via the breath actuated devices, are one of the important factors that can influence the efficiency of the drug delivery by the inhalation route. The peak inspiratory flow (PIF) rates achieved by COPD patients through different breath actuated dry power inhalers may differ because of the differences in internal resistance of the different type of devices. The results of inspiratory airflow rate and pressure drop over time, from this study, provided an assessment of the range and variability of inhalation profile characteristics generated by COPD patients within the population selected for this study (e.g. demographics, gender, disease control) through the Breezhaler and the other marketed comparator DPIs.
The inhalation profiles were obtained through an Inhalation Profile Recorder (IPR). The inhalation profile recorder was a data acquisition device which consists of a computer, an interface unit and a pressure transducer. This allowed it to measure the real time dynamic pressure drop at the mouthpiece of the inhaler during an inhalation maneuver. On the graphic user interface, plots of inspiratory pressure drop versus time and flow rate versus time are displayed in real time. The investigator or designated study personnel at site was responsible for typing in the Test Location, selecting the Inhaler Type (Breezhaler, Ellipta, Handihaler), typing in the Patient ID and Patient Age, selecting Male or Female, and recording Patient Comments made during the test session, as necessary.
Each patient were required to generate three (03) inhalational profiles through each of the three (03) study devices: Breezhaler®, Ellipta® and Handihaler®.
- Being tested
- Breezhaler®, Ellipta®, Handihaler®
- Keywords
- COPD, Cachexia due to chronic obstructive pulmonary disease, wasting syndrome, Loss of weight, muscle atrophy, loss of body mass, signficant loss of appetite, cachectic syndrome
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Wasting Syndrome, Weight Loss, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breezhaler®Device
No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
Ellipta®Device
No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
Handihaler®Device
No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
| Study group | Role | What they receive |
|---|---|---|
| Breezhaler® | Experimental | Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). Receives: Device: Breezhaler® |
| Ellipta® | Other | Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). Receives: Device: Ellipta® |
| Handihaler® | Other | Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). Receives: Device: Handihaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS
The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.
Measured: Visit 2 (Day 1)
Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS
The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.
This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values.
Measured: Visit 2 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start16 Dec 2015
- Primary completion29 Apr 2016
- Study completion29 Apr 2016
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 Pulmonary Disease, Chronic Obstructive (COPD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharma, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596009
- Sponsor's protocol ID
- CNVA237A2403
- Status last verified
- Jun 2018
- First submitted
- 14 Oct 2015
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Altman P, Wehbe L, Dederichs J, Guerin T, Ament B, Moronta MC, Pino AV, Goyal P. Comparison of peak inspiratory flow rate via the Breezhaler(R), Ellipta(R) and HandiHaler(R) dry powder inhalers in patients with moderate to very severe COPD: a randomized cross-over trial. BMC Pulm Med. 2018 Jun 14;18(1):100. doi: 10.1186/s12890-018-0662-0.
PubMed 29898702
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-label Cross-over Study to Compare Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Dry Powder Inhaler Devices
- ClinicalTrials.gov ID
- NCT02596009
- Acronym / sponsor ID
- CNVA237A2403
- Keywords
- COPD, Cachexia due to chronic obstructive pulmonary disease, wasting syndrome, Loss of weight, muscle atrophy, loss of body mass, signficant loss of appetite, cachectic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 29 Apr 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 26 Jun 2018
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 was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active drug or placebo were administered to patients in this study.
Detailed description
The inspiratory flow rates achieved by the COPD patients, via the breath actuated devices, are one of the important factors that can influence the efficiency of the drug delivery by the inhalation route. The peak inspiratory flow (PIF) rates achieved by COPD patients through different breath actuated dry power inhalers may differ because of the differences in internal resistance of the different type of devices. The results of inspiratory airflow rate and pressure drop over time, from this study, provided an assessment of the range and variability of inhalation profile characteristics generated by COPD patients within the population selected for this study (e.g. demographics, gender, disease control) through the Breezhaler and the other marketed comparator DPIs.
The inhalation profiles were obtained through an Inhalation Profile Recorder (IPR). The inhalation profile recorder was a data acquisition device which consists of a computer, an interface unit and a pressure transducer. This allowed it to measure the real time dynamic pressure drop at the mouthpiece of the inhaler during an inhalation maneuver. On the graphic user interface, plots of inspiratory pressure drop versus time and flow rate versus time are displayed in real time. The investigator or designated study personnel at site was responsible for typing in the Test Location, selecting the Inhaler Type (Breezhaler, Ellipta, Handihaler), typing in the Patient ID and Patient Age, selecting Male or Female, and recording Patient Comments made during the test session, as necessary.
Each patient were required to generate three (03) inhalational profiles through each of the three (03) study devices: Breezhaler®, Ellipta® and Handihaler®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breezhaler® | Experimental | Device: Breezhaler®Each patient was required to inhale via Breezhaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). |
| Ellipta® | Other | Device: Ellipta®Each patient were required to inhale via Ellipta® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). |
| Handihaler® | Other | Device: Handihaler®Each patient were required to inhale via Handihaler® in a randomized cross-over sequence. The randomization numbers were generated using 6 sequences: BEH, EHB, HBE, BHE, EBH, HEB (B: Breezhaler, E: Ellipta, H: Handihaler). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g., 10 pack years = 1 pack/day × 10 years, ½ pack/day × 20 years, etc.).
- Note: A pack of cigarettes is equal to 20 cigarettes. Occasional smoking of cigars is not relevant to smoking history.
- An ex-smoker is defined as a patient who has not smoked for ≥6 months at screening.
- COPD patients with moderate to very severe airflow limitation (spirometric classification: GOLD 2, 3 or 4) at time of screening,
- Willing patients assessed as suitable by investigator to reproducibly perform inhalational manoeuvers through study devices as required by the standard protocol
Key exclusion criteria (7 listed)
- Patients with a history of asthma or onset of respiratory symptoms prior to the age of 40 years
- Use of short acting bronchodilating agent (SABA) as rescue (reliever) medication within 6 hours prior to or during inhalational profile assessments for the study [Note: Use of rescue medication should not be restricted if patient feels the need of the rescue/ reliever medication because of the diseased state. Safety and disease management should be priority and the suitability of such a patient for the study or relevance of the (study) assessments done for the study should be reviewed, as appropriate.]
- Patients with any history of premature birth less than 33 weeks gestation or significant level of respiratory care including mechanical ventilation required as neonate affecting the respiratory tract or chronic lung diseases, which in the opinion of the investigator or designated study personnel at site may interfere with the study evaluation or optimal participation in the study.
- Any major chronic illness including but not limited to a diagnosis of non-skin cancer, cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder).
- Patients who have had a COPD exacerbation that required treatment with antibiotics or oral corticosteroids or hospitalization in the 6 weeks prior to screening
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 |
|---|---|---|
| Breezhaler®No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device. | Device | Breezhaler® |
| Ellipta®No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device. | Device | Ellipta® |
| Handihaler®No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device. | Device | Handihaler® |
Primary outcome
Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS
Time frame: Visit 2 (Day 1)
The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.
Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS
Time frame: Visit 2 (Day 1)
The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit. This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29898702Altman P, Wehbe L, Dederichs J, Guerin T, Ament B, Moronta MC, Pino AV, Goyal P. Comparison of peak inspiratory flow rate via the Breezhaler(R), Ellipta(R) and HandiHaler(R) dry powder inhalers in patients with moderate to very severe COPD: a randomized cross-over trial. BMC Pulm Med. 2018 Jun 14;18(1):100. doi: 10.1186/s12890-018-0662-0.
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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.
Novartis Pharma study director
Novartis Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Breezhaler®, Ellipta® and Handihaler® in people with Pulmonary Disease, Chronic Obstructive (COPD), run by Novartis Pharmaceuticals at 5 sites in Argentina.
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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2018). 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?
Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS (time frame: Visit 2 (Day 1)). The study lists 2 primary outcomes in all. 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 NCT02596009, 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 26 Jun 2018.