A Phase 2 interventional study of NVA237 100 µg and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis. Completed at 21 sites in 6 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-05-21.
Sponsored by Novartis · Phase 2, Interventional, and Treatment
This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 281 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Blood eosinophil count > 400/mm3, onset of symptoms prior to age 40 years.
Other protocol-defined inclusion/exclusion criteria may apply
Drug: NVA237 100 µg
Drug: NVA237 200 µg
Drug: Placebo
Dry powder inhalation once a day for up to 28 days
Also known as: Glycopyrronium Bromide
Placebo to NVA237 dry powder inhalation once a day for up to 28 days
Dry powder inhalation once a day for up to 28 days
Also known as: Glycopyrronium Bromide
Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
Time frame: 28 days
Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 \& 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.
Time frame: 28 Days
| Milestone | NVA237 100 µg | NVA237 200 µg | Placebo |
|---|---|---|---|
| Started | 92 | 98 | 91 |
| Completed | 87 | 89 | 74 |
| Not completed | 5 | 9 | 17 |
| Withdrew: Adverse event | 4 | 3 | 6 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 |
| Withdrew: Subjects no longer requires study drug | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 3 | 4 |
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
| Participants | NVA237 100 µg | NVA237 200 µg | Placebo |
|---|---|---|---|
| Total number of patients with any AE | 26 | 26 | 24 |
| Total number with any significant AE | 3 | 4 | 6 |
Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 \& 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.
| Liters | NVA237 100 µg | NVA237 200 µg | Placebo |
|---|---|---|---|
| Trough FEV1 Day 1 | 1.465 ± 0.0152 | 1.480 ± 0.0149 | 1.334 ± 0.0154 |
| Trough FEV1 Day 28 | 1.502 ± 0.0182 | 1.492 ± 0.0180 | 1.341 ± 0.0200 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NVA237 100 µg | — | 0/92 (0%) | 7/92 (7.6%) |
| NVA237 200 µg | — | 1/98 (1%) | 10/98 (10.2%) |
| Placebo | — | 1/91 (1.1%) | 4/91 (4.4%) |
| Event | NVA237 100 µg | NVA237 200 µg | Placebo |
|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/92 | 0/98 | 1/91 |
| PneumoniaInfections and infestations | 0/92 | 1/98 | 0/91 |
| Event | NVA237 100 µg | NVA237 200 µg | Placebo |
|---|---|---|---|
| Dry mouthGastrointestinal disorders | 3/92 | 7/98 | 0/91 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 5/92 | 3/98 | 4/91 |
| Age Continuous(years) | NVA237 100 µg | NVA237 200 µg | Placebo | Total |
|---|---|---|---|---|
| Mean | 64.2 ± 7.93 | 62.6 ± 9.04 | 63.4 ± 9.44 | 63.4 ± 8.82 |
| Sex: Female, Male(Participants) | NVA237 100 µg | NVA237 200 µg | Placebo | Total |
|---|---|---|---|---|
| Female | 35 | 29 | 27 | 91 |
| Male | 57 | 69 | 64 | 190 |
| Ethnicity (NIH/OMB)(Participants) | NVA237 100 µg | NVA237 200 µg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 17 | 15 | 11 | 43 |
| Not Hispanic or Latino | 72 | 79 | 76 | 227 |
| Unknown or Not Reported | 3 | 4 | 4 | 11 |
| Race (NIH/OMB)(Participants) | NVA237 100 µg | NVA237 200 µg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 0 | 3 | 3 | 6 |
| White | 90 | 94 | 88 | 272 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 0 | 2 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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