Chronic Obstructive Pulmonary DiseasePhase 2NCT00856193
A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing NVA237 in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 2 sites in 2 countries.
Trial summary
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NVA237
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2009to May 2009
- Phase
- Phase 2
- 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
- Male or female aged greater than 40 years with COPD Current or ex-smokers
Who cannot join
- Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Germany1 site
Harrison Clinical Research Deutschland GmbH
Albrechtstrasse 14, Munich, 80636
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Placebo, NVA237
- Keywords
- COPD, Bronchodilator
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
NVA237Drug
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
| Study group | Role | What they receive |
|---|---|---|
| Placebo then NVA237 50μg | Placebo comparator | Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Receives: Drug: Placebo; Drug: NVA237 |
| NVA237 50μg then placebo | Experimental | NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. Receives: Drug: Placebo; Drug: NVA237 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Measured: From Day 1 to 0-24 hours after drug administration on Day 14
Secondary outcomes (3)
Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Measured: From day 1 to 0 -12 hours after drug administration on Day 14
Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Measured: From Day 1 to 12 hours-24 hours after drug administration on Day 14
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)
According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionMay 2009
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 Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856193
- Sponsor's protocol ID
- CNVA237A2207
- Other IDs
- 2008-006849-28, 2008
- Status last verified
- Jun 2011
- First submitted
- 4 Mar 2009
- Last updated
- 14 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00856193
- Acronym / sponsor ID
- CNVA237A2207
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Bronchodilator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then NVA237 50μg | Placebo comparator | Drug: Placebo, Drug: NVA237Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. |
| NVA237 50μg then placebo | Experimental | Drug: Placebo, Drug: NVA237NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female aged greater than 40 years with COPD Current or ex-smokers
Key exclusion criteria (1 listed)
- Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| PlaceboMatching placebo capsules were supplied for inhalation once daily with Concept 1 device. | Drug | NVA237 50μg then placebo, Placebo then NVA237 50μg |
| NVA237NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device. | Drug | NVA237 50μg then placebo, Placebo then NVA237 50μg |
Primary outcome
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
Time frame: From Day 1 to 0-24 hours after drug administration on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
3 secondary outcomes
Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14
Time frame: From day 1 to 0 -12 hours after drug administration on Day 14
Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14
Time frame: From Day 1 to 12 hours-24 hours after drug administration on Day 14
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NVA237 in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 2 sites in 2 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 1 inclusion and 1 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 6 May 2011). 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?
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 (time frame: From Day 1 to 0-24 hours after drug administration on Day 14). 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 14 Sep 2016.