Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00570778
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing indacaterol/glycopyrrolate and indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 22 sites in 5 countries.
Trial summary
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- indacaterol/glycopyrrolate and indacaterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Dec 2007to Sep 2008
- 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 adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
- Patients who have smoking history of at least 10 pack years.
- Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.
Who cannot join
- Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
- Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
- Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Show all 12Show fewer
- Patients with uncontrolled Type I and Type II diabetes.
- History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
- Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
- Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
- Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Germany6 sites
Novartis Investigator Site
Bad Wörishofen
Novartis Investigator Site
Berlin
Novartis Investigator Site
Frankfurt
Novartis Investigator Site
Mainz
Novartis Investigator Site
Rüdersdorf
Novartis Investigator Site
Wiesbaden
Netherlands6 sites
Novartis Investigator Site
Almelo
Novartis Investigator Site
Breda
Novartis Investigator site
Eindhoven
Novartis investigator site
Heerlen
Novartis Investigator Site
Nijmegen
Novartis Investigator Site
Veldhoven
Belgium4 sites
Novartis Investigator Site
Antwerp
Novartis Investigator Site
Ghent
Novartis Investigator Site
Jambes
Novartis Investigator Site
Sankt Vith
United States3 sites
Novartis Investigator Site
Charlotte, North Carolina
Novartis Investigator site
Raleigh, North Carolina
Novartis Investigator Site
St Louis, Missouri
Canada3 sites
Novartis Investigator Site
Moncton
Novartis Investigator Site
Montreal
Novartis Investigator site
Toronto
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
- Being tested
- indacaterol/glycopyrrolate, indacaterol, placebo
- Keywords
- QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
- 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.
indacaterol/glycopyrrolateDrug
Also called QVA149
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
indacaterolDrug
Also called QAB149
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
placeboDrug
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| indacaterol/glycopyrrolate 300/50 μg | Experimental | One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. Receives: Drug: indacaterol/glycopyrrolate |
| indacaterol 600 μg | Active comparator | Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. Receives: Drug: indacaterol |
| indacaterol 300 μg | Active comparator | One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. Receives: Drug: indacaterol |
| placebo | Placebo comparator | Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Measured: Baseline, Day 7
Secondary outcomes (2)
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Measured: Day 7
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Additional information about adverse events can be found in the Adverse Event Section.
Measured: 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
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 Chronic Obstructive Pulmonary Disease (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570778
- Sponsor's protocol ID
- CQVA149A2204
- Status last verified
- Jun 2018
- First submitted
- 10 Dec 2007
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.
PubMed 20978028
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00570778
- Acronym / sponsor ID
- CQVA149A2204
- Keywords
- QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Posted 28 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| indacaterol/glycopyrrolate 300/50 μg | Experimental | Drug: indacaterol/glycopyrrolateOne indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. |
| indacaterol 600 μg | Active comparator | Drug: indacaterolTwo indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. |
| indacaterol 300 μg | Active comparator | Drug: indacaterolOne capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. |
| placebo | Placebo comparator | Drug: placeboTwo placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
- Patients who have smoking history of at least 10 pack years.
- Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.
Key exclusion criteria (12 listed)
- Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
- Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
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 |
|---|---|---|
| indacaterol/glycopyrrolateAlso: QVA149Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days. | Drug | indacaterol/glycopyrrolate 300/50 μg |
| indacaterolAlso: QAB149Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. | Drug | indacaterol 300 μg, indacaterol 600 μg |
| placeboPlacebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days. | Drug | placebo |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Time frame: Baseline, Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
2 secondary outcomes
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Time frame: Day 7
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Time frame: 47 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20978028van Noord JA, Buhl R, Laforce C, Martin C, Jones F, Dolker M, Overend T. QVA149 demonstrates superior bronchodilation compared with indacaterol or placebo in patients with chronic obstructive pulmonary disease. Thorax. 2010 Dec;65(12):1086-91. doi: 10.1136/thx.2010.139113. Epub 2010 Oct 26.
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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 chair
Novartis Pharmaceuticals
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indacaterol/glycopyrrolate and indacaterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 22 sites in 5 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 4 inclusion and 12 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Netherlands, Belgium, United States, Canada. 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 28 Feb 2013). 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?
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 (time frame: Baseline, Day 7). 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 NCT00570778, 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 Jul 2018.