Chronic Obstructive Pulmonary DiseasePhase 4FASTNCT01922271
Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing NVA237, Tiotropium and Salbutamol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 14 sites in Germany.
Trial summary
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance 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
- What is being tested?
- NVA237, Tiotropium and Salbutamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 14 sitesGermany
- Study dates
- Aug 2013to Jan 2014
- Phase
- Phase 4
- 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
- Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Who cannot join
- Pregnant or nursing (lactating) women
- Patients who have a clinically significant laboratory abnormality at run-in
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
- Patients with any history of asthma
- Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
- Patients receiving medications in the classes listed in the protocol as prohibited.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Novartis Investigative Site
Berlin, 12043
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 12687
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Gelsenkirchen, 45879
Novartis Investigative Site
Großhansdorf, 22947
Novartis Investigative Site
Gummersbach, 51643
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Sonneberg, 96515
About this study
Official title: A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NVA237, Tiotropium, Placebo to NVA237, Placebo to tiotropium, Salbutamol
- Keywords
- COPD
- 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.
NVA237Drug
NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)
TiotropiumDrug
Tiotropium 18 μg once daily delivered via HandiHaler® device.
Placebo to NVA237Drug
Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).
Placebo to tiotropiumDrug
Placebo to tiotropium once daily delivered via HandiHaler® device
SalbutamolDrug
Used as resuce medication
| Study group | Role | What they receive |
|---|---|---|
| NVA237 followed by tiotropium | Experimental | Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. Receives: Drug: NVA237; Drug: Tiotropium; Drug: Placebo to tiotropium; Drug: Salbutamol |
| Tiotropium followed by NVA237 | Experimental | Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication. Receives: Drug: Placebo to NVA237; Drug: Salbutamol |
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) 0-2
Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).
Measured: Day 1
Secondary outcomes (6)
Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
Measured: Day 1
Specific Airway Resistance (sRAW)
Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.
Measured: Day 1
Functional Resistance Capacity (FRCpleth)
Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).
Measured: Day 1
Residual Volume (RV)
Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).
Measured: Day 1
Total Lung Capacity (TLC)
Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.
Measured: Day 1
Inspiratory Capacity (IC)
Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
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 DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 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
- NCT01922271
- Sponsor's protocol ID
- CNVA237ADE02
- Acronym
- FAST
- Status last verified
- Dec 2014
- First submitted
- 9 Aug 2013
- Last updated
- 1 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9.
PubMed 27940287
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)
- ClinicalTrials.gov ID
- NCT01922271
- Acronym / sponsor ID
- FAST / CNVA237ADE02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Posted 1 Jan 2015
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 study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVA237 followed by tiotropium | Experimental | Drug: NVA237, Drug: Tiotropium, Drug: Placebo to tiotropium, Drug: SalbutamolPeriod 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. |
| Tiotropium followed by NVA237 | Experimental | Drug: Placebo to NVA237, Drug: SalbutamolPeriod 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults aged ≥40 years
- Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of ≤70% and FEV1 ≥ 30% of predicted normal values.
- Current or ex-smokers who have a smoking history of at least 10 pack years.
Key exclusion criteria (7 listed)
- Pregnant or nursing (lactating) women
- Patients who have a clinically significant laboratory abnormality at run-in
- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered).
- Patients with any history of asthma
- Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
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 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI) | Drug | NVA237 followed by tiotropium |
| TiotropiumTiotropium 18 μg once daily delivered via HandiHaler® device. | Drug | NVA237 followed by tiotropium |
| Placebo to NVA237Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI). | Drug | Tiotropium followed by NVA237 |
| Placebo to tiotropiumPlacebo to tiotropium once daily delivered via HandiHaler® device | Drug | NVA237 followed by tiotropium |
| SalbutamolUsed as resuce medication | Drug | NVA237 followed by tiotropium, Tiotropium followed by NVA237 |
Primary outcome
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
Time frame: Day 1
Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).
6 secondary outcomes
Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
Time frame: Day 1
Specific Airway Resistance (sRAW)
Time frame: Day 1
Functional Resistance Capacity (FRCpleth)
Time frame: Day 1
Residual Volume (RV)
Time frame: Day 1
Total Lung Capacity (TLC)
Time frame: Day 1
Inspiratory Capacity (IC)
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27940287Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NVA237, Tiotropium and Salbutamol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 14 sites in Germany.
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 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Jan 2015). 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) 0-2 (time frame: Day 1). 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 NCT01922271, 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 1 Jan 2015.