AsthmaPhase 3NCT02127697
Study of Efficacy and Safety of NVA237 in Patients With Poorly Controlled Asthma
A Phase 3 study testing NVA237 and salbutamol/ albuterol in people with Asthma, run by Novartis Pharmaceuticals.
Trial summary
The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- NVA237 and salbutamol/ albuterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2017
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to <75 years; Patients with a diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma must have been made before the patient was 40; Increase in forced expiratory volume in 1 second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤ 80% of the predicted normal value for the patient; Patients who qualify for treatment (according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5 at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in the previous 12 months that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation
Who cannot join
- Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof:
- Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); 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 must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged throughout the course of the study;
About this study
Official title: A Randomized, Double-blind, Parallel Group, 52-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 in Patients With Poorly Controlled Asthma
The study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment.
Read the detailed description
The study will assess efficacy and safety of NVA237 compared to placebo, in addition to background therapy with LABA/ICS in patients with poorly controlled asthma.
- Conditions
- Asthma
- Being tested
- NVA237, Placebo to NVA237, salbutamol/ albuterol
- Keywords
- Asthma, poorly controlled asthma, LAMA, Long-Acting Muscarinic Antagonist, Glycopyrronium, Glycopyrronium bromide, Anticholinergic
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVA237Drug
NVA237 capsules for inhalation, delivered via Concept1 once daily
Placebo to NVA237Drug
Placebo to NVA237 delivered via Concept1 once daily
salbutamol/ albuterolDrug
Taken as rescue medication
| Study group | Role | What they receive |
|---|---|---|
| NVA237 | Experimental | Participants will receive NVA237 once daily in addition to their background therapy during the 52- week treatment period. All participants will receive salbutamol/ albuterol as rescue medication. Receives: Drug: NVA237; Drug: salbutamol/ albuterol |
| Placebo | Placebo comparator | Participants will receive placebo to NVA237 in addition to their background therapy during the 52-week treatment period. All participants will receive salbutamol/ albuterol as rescue medication. Receives: Drug: Placebo to NVA237; Drug: salbutamol/ albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26
Spirometry testing will be performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing.
Measured: Week 26
Secondary outcomes (22)
Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment
Asthma exacerbations are considered to be moderate if treatment with rescue systemic corticosteroids for greater than or equal to 3 days as outpatient or less than or equal to 24 hour emergency room visit was required. Asthma exacerbations are considered severe if treatment with rescue systemic corticosteroids for greater than or equal to 3 days and hospitalization or emergency department visit greater than 24 hours were required or death due to asthma. The time to the first moderate or severe asthma exacerbation is the study day on which the patient experienced first moderate or severe asthma exacerbation.
Measured: 52 weeks
Asthma Control Questionnaire (ACQ-7) Overall Score at Week 26
Asthma symptoms will be evaluated by the Asthma Control Questionnaire (ACQ-7). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0-good control, 6-poor control), and one item where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1. The overall score is an average of the 7 items.
Measured: Week 26
Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Over 52-Week Treatment Period.
There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question will be answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.
Measured: Week 12, Week 26, Week 52
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Over 52-Week Treatment Period
SGRQ is a health related quality of life questionnaire consisting of 50 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Measured: Week 12, Week 26, Week 52
Shortened Version of the Asthma Control Questionnaire (ACQ-6)
This shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 items (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = maximum control; 6 = no control ) and a total score is the mean of 6 items.
Measured: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Shortened Version of the Asthma Control Questionnaire (ACQ-5)
This shortened version of the asthma control questionnaire (symptoms only) consists of 5 items (nighttime waking, symptoms on waking, activity limitation, shortness of breath, and wheeze) between 0 and 6 (0 = maximum control; 6 = no control) and a total score is the mean of 5 items.
Measured: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Peak Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
Spirometry will be conducted according to internationally accepted standards. Peak FEV1= the maximum FEV1 recorded in the period between 0 minutes and 3 hours post dose.
Measured: Day 1, Week 4, Week 26, Week 52
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC0-3h) Over 52 Weeks of Treatment
FEV1 will be measured with spirometry conducted according to internationally accepted standards. Measurements will be made at 5, 15, and 30 minutes; and 1, 2, and 3 hours post-dose.
Measured: Day 1, Week 4, Week 26, Week 52
Predose Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
FEV1 will be measured with spirometry conducted according to internationally accepted standards. Predose FEV1 defined as the mean of FEV1 at -45 minutes and -15 minutes before the morning dose.
Measured: Week 2, Week 4, Week 8, Week 26, Week 39, Week 52
Trough Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
FEV1 will be measured with spirometry conducted according to internationally accepted standards. Trough FEV1 defined as the mean of FEV1 23 hours 15 minutes and the 23 hours 45 minutes post dose.
Measured: Day 2, Week 4, Week 26, Week 52
Mean Daily Number of Puffs of Rescue Medication Over 52 Weeks of Treatment
Participants will maintain a diary to record the number of puffs of rescue Short-acting B2 agonist (SABA) used in the previous 24 hours to treat asthma symptoms.
Measured: 52 Weeks
Rate of Moderate or Severe Asthma Exacerbation
Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years
Measured: 52 Weeks
Rate of Severe Asthma Exacerbation
Rate of severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years
Measured: 52 Weeks
Time To First Severe Asthma Exacerbation
Asthma exacerbations are considered to be severe if treatment with rescue systemic corticosteroids for greater than or equal to 3 days and hospitalization or emergency department visit greater than 24 hours required or death due to asthma. The time to the first severe asthma exacerbation = the study day on which the patient experienced first severe asthma exacerbation.
Measured: 52 Weeks
Time To First Asthma Exacerbation (Mild, Moderate, or Severe)
Asthma exacerbation are considered Mild if treatment with inhaled or nebulized Short-acting B2 agonist (SABA), increase in inhaled corticosteroid only, or requires less than 3 days of systemic corticosteroids. Asthma exacerbations are considered to be moderate if treatment with rescue systemic corticosteroids for greater than or equal to 3 days as outpatient or less than or equal to 24 hour emergency room visit required. Asthma exacerbations are considered severe if treatment with rescue systemic corticosteroids for greater than or equal to 3 days and hospitalization or emergency department visit greater than 24 hours required or death due to asthma. The time to the first mild, moderate, or severe asthma exacerbation = the study day on which the patient experienced first asthma exacerbation of any severity.
Measured: 52 Weeks
Rate of Asthma Exacerbation (Mild, Moderate, or Severe)
Rate of mild, moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years
Measured: 52 Weeks
Morning Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment
Peak Expiratory Flow (PEF) will be measured every morning within 15 minutes of waking and before dosing using a peak flow meter, and recorded in the patient diary.
Measured: Every 3 Months, 52 Weeks
Evening Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment
Peak Expiratory Flow (PEF) will be measured every evening using a peak flow meter, and recorded in the patient diary.
Measured: Every 3 Months, 52 Weeks
Asthma Control Diary (ACD) Symptom Score Over 52-Week Treatment Period
The mean symptom score for ACD is defined as the sum of daily symptom scores divided by number of days where diary records were made. The daily symptom score for ACD is defined as the mean of the responses to the 5 symptom questions for any day with ACD questions answered.
Measured: Every 3 Months, 52 Weeks
Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
FEV1 will be measured with spirometry conducted according to internationally accepted standards.
Measured: Week 1, Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Measured: Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Asthma Control Questionnaire (ACQ-7) Over 52 Weeks of Treatment
Asthma symptoms will be evaluated by the Asthma Control Questionnaire (ACQ). The ACQ has six questions to be answered by the patient, each with a 7 point scale (0-good control, 6-poor control), and one item where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1. The overall score is an average of the 7 items.
Measured: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127697
- Sponsor's protocol ID
- CNVA237B2301
- Status last verified
- Apr 2015
- First submitted
- 29 Apr 2014
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, 52-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 in Patients With Poorly Controlled Asthma
- ClinicalTrials.gov ID
- NCT02127697
- Acronym / sponsor ID
- CNVA237B2301
- Conditions
- Asthma
- Keywords
- Asthma, poorly controlled asthma, LAMA, Long-Acting Muscarinic Antagonist, Glycopyrronium, Glycopyrronium bromide, Anticholinergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 May 2014 (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 study will assess efficacy, safety and tolerability of NVA237 compared to placebo in patients with poorly controlled asthma over 52 weeks of treatment.
Detailed description
The study will assess efficacy and safety of NVA237 compared to placebo, in addition to background therapy with LABA/ICS in patients with poorly controlled asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVA237 | Experimental | Drug: NVA237, Drug: salbutamol/ albuterolParticipants will receive NVA237 once daily in addition to their background therapy during the 52- week treatment period. All participants will receive salbutamol/ albuterol as rescue medication. |
| Placebo | Placebo comparator | Drug: Placebo to NVA237, Drug: salbutamol/ albuterolParticipants will receive placebo to NVA237 in addition to their background therapy during the 52-week treatment period. All participants will receive salbutamol/ albuterol as rescue medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent must be obtained before any assessment is performed; Male and female adult patients aged 18 to <75 years; Patients with a diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma must have been made before the patient was 40; Increase in forced expiratory volume in 1 second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤ 80% of the predicted normal value for the patient; Patients who qualify for treatment (according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5 at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in the previous 12 months that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation
Key exclusion criteria (2 listed)
- Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component thereof:
- Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other excipients of the study drug, long and short acting beta-2 agonists, corticosteroids; Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction, arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment; Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered); Patients who have had an asthma exacerbation that required either treatment with additional or increased dose of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to screening; Patients who have smoked or inhaled tobacco products within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (Note:10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); 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 must have been so for at least 3 months prior to run-in, and must be expected to remain unchanged 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 |
|---|---|---|
| NVA237NVA237 capsules for inhalation, delivered via Concept1 once daily | Drug | NVA237 |
| Placebo to NVA237Placebo to NVA237 delivered via Concept1 once daily | Drug | Placebo |
| salbutamol/ albuterolTaken as rescue medication | Drug | NVA237, Placebo |
Primary outcome
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 26
Time frame: Week 26
Spirometry testing will be performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing.
22 secondary outcomes
Time to First Moderate or Severe Asthma Exacerbation Over 52 Weeks of Treatment
Time frame: 52 weeks
Asthma Control Questionnaire (ACQ-7) Overall Score at Week 26
Time frame: Week 26
Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Over 52-Week Treatment Period.
Time frame: Week 12, Week 26, Week 52
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Over 52-Week Treatment Period
Time frame: Week 12, Week 26, Week 52
Shortened Version of the Asthma Control Questionnaire (ACQ-6)
Time frame: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Shortened Version of the Asthma Control Questionnaire (ACQ-5)
Time frame: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Peak Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
Time frame: Day 1, Week 4, Week 26, Week 52
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC0-3h) Over 52 Weeks of Treatment
Time frame: Day 1, Week 4, Week 26, Week 52
Predose Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
Time frame: Week 2, Week 4, Week 8, Week 26, Week 39, Week 52
Trough Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks of Treatment
Time frame: Day 2, Week 4, Week 26, Week 52
Mean Daily Number of Puffs of Rescue Medication Over 52 Weeks of Treatment
Time frame: 52 Weeks
Rate of Moderate or Severe Asthma Exacerbation
Time frame: 52 Weeks
Rate of Severe Asthma Exacerbation
Time frame: 52 Weeks
Time To First Severe Asthma Exacerbation
Time frame: 52 Weeks
Time To First Asthma Exacerbation (Mild, Moderate, or Severe)
Time frame: 52 Weeks
Rate of Asthma Exacerbation (Mild, Moderate, or Severe)
Time frame: 52 Weeks
Morning Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment
Time frame: Every 3 Months, 52 Weeks
Evening Daily Peak Expiratory Flow (PEF) Over 52 Weeks of Treatment
Time frame: Every 3 Months, 52 Weeks
Asthma Control Diary (ACD) Symptom Score Over 52-Week Treatment Period
Time frame: Every 3 Months, 52 Weeks
Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Forced Vital Capacity (FVC)
Time frame: Week 2, Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Asthma Control Questionnaire (ACQ-7) Over 52 Weeks of Treatment
Time frame: Week 4, Week 8, Week 12, Week 26, Week 39, Week 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NVA237 and salbutamol/ albuterol in people with Asthma, run by Novartis Pharmaceuticals.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Forced Expiratory Volume in 1 Second (FEV1) at Week 26 (time frame: Week 26). 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 13 Apr 2015.