AsthmaPhase 2/3NCT03137784
Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma
A Phase 2/3 study testing NVA237 (glycopyrronium bromide) in people with Asthma, run by Novartis Pharmaceuticals at 21 sites in 6 countries.
Trial summary
The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- NVA237 (glycopyrronium bromide)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 4 May 2017to 29 Dec 2017
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult patients aged >= 18 or =< 65 years
- Patients with a diagnosis of asthma for a period of at least 1 year receiving daily treatment of ICS/LABA in a stable regimen for >= 4 weeks
- Pre-bronchodilator FEV1 of >= 50% and =< 80% of the predicted normal value and an increase in FEV1 of 12% and >= 200 ml during reversibility testing
Who cannot join
- Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks
- Patients who have had a respiratory tract infection within 4 weeks prior to screening.
- Patients who have smoked or inhaled tobacco products within the past 6 month of screening.
- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).
- Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.
- Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.
- Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy).
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States6 sites
Novartis Investigative Site
El Paso, Texas, 79903
Novartis Investigative Site
Medford, Oregon, 97504
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
St Louis, Missouri, 63141
Germany5 sites
Novartis Investigative Site
Berlin, 10119
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Großhansdorf, 22927
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Wiesbaden, 65187
Belgium3 sites
Novartis Investigative Site
Erpent, 5100
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Mechelen, 2800
Latvia3 sites
Novartis Investigative Site
Daugavpils, LVA, LV-5417
Novartis Investigative Site
Riga, LV 1002
Novartis Investigative Site
Riga, LV-1038
Japan2 sites
Novartis Investigative Site
Shinjuku-ku, Tokyo, 169-0073
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0014
Lithuania2 sites
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Klaipėda, LT-92288
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled 3-period Complete Cross-over Study to Assess the Bronchodilator Effects and Safety of Glycopyrronium Bromide (NVA237) (25 ug and 50 ug o.d.) in Asthma Patients.
The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
Read the detailed description
This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical trial design. During a screening epoch patient eligibility will be assessed. The screening epoch will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication. After the Run-in period patients will be randomized to one of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment period one is followed by a 10 to 14 days washout period after which patients begin the second 7-day treatment period which is then followed by a second 10 to 14 days washout period followed by the third 7-day treatment period. At the end of each treatment period spirometry will be performed to assess the primary endpoint in terms of trough FEV1. The study population will consist of approximately 144 patients with asthma who have been treated in a stable regimen of ICS/LABA for at least 4 weeks prior to screening.
- Conditions
- Asthma
- Being tested
- NVA237 (glycopyrronium bromide), Placebo
- Keywords
- asthma,, NVA237,, glycopyrronium bromide, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVA237 (glycopyrronium bromide)Drug
In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose
PlaceboDrug
In each treatment arm, patient will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| 1(NVA237 50 ug/NVA237 25 ug/placebo) | Other | Treatment sequence: NVA 237 50 ug, 25 ug and placebo Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
| 2(NVA237 50 ug/placebo/NVA237 25 ug) | Other | Treatment sequence: NVA 237 50 ug, placebo and 25 ug Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
| 3 (NVA237 25 ug/NVA237 50 ug/placebo) | Other | Treatment sequence: NVA237 25 ug, 50 ug and placebo Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
| 4 (NVA237 25 ug/placebo/NVA237 50 ug) | Other | Treatment sequence: NVA 237 25 ug, placebo and 50 ug Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
| 5 (placebo/NVA237 50 ug/ NVA237 25 ug) | Other | Treatment sequence: Placebo, NVA237 50 ug and 25 ug Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
| 6 (placebo/ NVA237 25 ug/NVA237 50 ug) | Other | Treatment sequence: placebo, NVA237 25 ug and 50 ug Receives: Drug: NVA237 (glycopyrronium bromide); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 After One Week of Treatment, Point Estimate
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose.
Measured: Following 1 week of treatment
Secondary outcomes (9)
FEV1 AUC (5 Min-1 h) After One Week of Treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-1h)
Measured: Following 1 week of treatment
FEV1 AUC (5 Min-4 h) After One Week of Treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-4h)
Measured: Following 1 week of treatment
FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day AUC (5 min - 23 h 45 min)
Measured: Following 1 week of treatment
Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Peak FEV1 following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect following 1 week of treatment was defined as the maximum FEV1 during the first 4 hour on that day.
Measured: Following 1 week of treatment
Trough Forced Vital Capacity (FVC) After 1 Week of Treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FVC following 1 week of treatment in respective treatment period. Trough Forced Vital Capacity (FVC) following 7 Days. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry
Measured: Following 1 week of treatment
Percent Change From Baseline in FEV1/FVC Ratio
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FEV1/FVC ratio following 1 week of treatment in respective treatment period
Measured: Following 1 week of treatment
Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period
A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value
Measured: Following 1 week of treatment
Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment
A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates
Measured: Following 1 week of treatment
Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment
A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs.
Measured: Following 1 week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start4 May 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
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.
- Other trials for AsthmaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137784
- Sponsor's protocol ID
- CQVM149B2204
- Status last verified
- Jan 2019
- First submitted
- 24 Apr 2017
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled 3-period Complete Cross-over Study to Assess the Bronchodilator Effects and Safety of Glycopyrronium Bromide (NVA237) (25 ug and 50 ug o.d.) in Asthma Patients.
- ClinicalTrials.gov ID
- NCT03137784
- Acronym / sponsor ID
- CQVM149B2204
- Conditions
- Asthma
- Keywords
- asthma,, NVA237,, glycopyrronium bromide, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 May 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 16 Jan 2019
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 trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
Detailed description
This study uses a randomized, double-blind, placebo controlled, 3-period cross-over clinical trial design. During a screening epoch patient eligibility will be assessed. The screening epoch will be followed by a 21-day Run-in epoch during which patients will continue their inhaled corticosteroids use but be withdrawn from LABA-treatment and switched to short-acting bronchodilator-rescue medication. After the Run-in period patients will be randomized to one of the 6 treatment sequences and enter the first 7-day study treatment period. Treatment period one is followed by a 10 to 14 days washout period after which patients begin the second 7-day treatment period which is then followed by a second 10 to 14 days washout period followed by the third 7-day treatment period. At the end of each treatment period spirometry will be performed to assess the primary endpoint in terms of trough FEV1. The study population will consist of approximately 144 patients with asthma who have been treated in a stable regimen of ICS/LABA for at least 4 weeks prior to screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1(NVA237 50 ug/NVA237 25 ug/placebo) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: NVA 237 50 ug, 25 ug and placebo |
| 2(NVA237 50 ug/placebo/NVA237 25 ug) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: NVA 237 50 ug, placebo and 25 ug |
| 3 (NVA237 25 ug/NVA237 50 ug/placebo) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: NVA237 25 ug, 50 ug and placebo |
| 4 (NVA237 25 ug/placebo/NVA237 50 ug) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: NVA 237 25 ug, placebo and 50 ug |
| 5 (placebo/NVA237 50 ug/ NVA237 25 ug) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: Placebo, NVA237 50 ug and 25 ug |
| 6 (placebo/ NVA237 25 ug/NVA237 50 ug) | Other | Drug: NVA237 (glycopyrronium bromide), Drug: PlaceboTreatment sequence: placebo, NVA237 25 ug and 50 ug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female adult patients aged >= 18 or =< 65 years
- Patients with a diagnosis of asthma for a period of at least 1 year receiving daily treatment of ICS/LABA in a stable regimen for >= 4 weeks
- Pre-bronchodilator FEV1 of >= 50% and =< 80% of the predicted normal value and an increase in FEV1 of 12% and >= 200 ml during reversibility testing
Key exclusion criteria (7 listed)
- Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks
- Patients who have had a respiratory tract infection within 4 weeks prior to screening.
- Patients who have smoked or inhaled tobacco products within the past 6 month of screening.
- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).
- Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.
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 |
|---|---|---|
| NVA237 (glycopyrronium bromide)In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose | Drug | 1(NVA237 50 ug/NVA237 25 ug/placebo), 2(NVA237 50 ug/placebo/NVA237 25 ug), 3 (NVA237 25 ug/NVA237 50 ug/placebo), 4 (NVA237 25 ug/placebo/NVA237 50 ug), 5 (placebo/NVA237 50 ug/ NVA237 25 ug), 6 (placebo/ NVA237 25 ug/NVA237 50 ug) |
| PlaceboIn each treatment arm, patient will receive placebo | Drug | 1(NVA237 50 ug/NVA237 25 ug/placebo), 2(NVA237 50 ug/placebo/NVA237 25 ug), 3 (NVA237 25 ug/NVA237 50 ug/placebo), 4 (NVA237 25 ug/placebo/NVA237 50 ug), 5 (placebo/NVA237 50 ug/ NVA237 25 ug), 6 (placebo/ NVA237 25 ug/NVA237 50 ug) |
Primary outcome
Trough FEV1 After One Week of Treatment, Point Estimate
Time frame: Following 1 week of treatment
To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose.
9 secondary outcomes
FEV1 AUC (5 Min-1 h) After One Week of Treatment
Time frame: Following 1 week of treatment
FEV1 AUC (5 Min-4 h) After One Week of Treatment
Time frame: Following 1 week of treatment
FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment
Time frame: Following 1 week of treatment
Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment
Time frame: Following 1 week of treatment
Trough Forced Vital Capacity (FVC) After 1 Week of Treatment
Time frame: Following 1 week of treatment
Percent Change From Baseline in FEV1/FVC Ratio
Time frame: Following 1 week of treatment
Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period
Time frame: Following 1 week of treatment
Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment
Time frame: Following 1 week of treatment
Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment
Time frame: Following 1 week of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NVA237 (glycopyrronium bromide) in people with Asthma, run by Novartis Pharmaceuticals at 21 sites in 6 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 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Belgium, Latvia, Japan and 1 more country. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jan 2019). 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?
Trough FEV1 After One Week of Treatment, Point Estimate (time frame: Following 1 week of treatment). 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 16 Jan 2019.