The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01574651 | Completed Phase 3 Results

• 2 other identifiers: CQVA149ADE012011-004870-26
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 144

Brief Summary

This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

QVA149; Health related quality of life; Formoterol; Tiotropium; COPD

Outcome Measures

Primary Outcomes (1)

• St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).

  SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.

  Baseline, week 26

Secondary Outcomes (8)

• St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).

  Baseline, week 26

• Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.

  Week 26

• Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks

  Week 26

• Percent of Participants With at Least One Exacerbation Requiring Hospitalization

  Week 26

• Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period

  Week 26

Study Arms (2)

QVA149 plus placebo to tiotropium and placebo to formoterol

EXPERIMENTAL

QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.

Drug: QVA149; Drug: Placebo to tiotropium; Drug: Placebo to formoterol

Tiotropium plus Formoterol and placebo to QVA149

ACTIVE COMPARATOR

Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Drug: Tiotropium; Drug: Formoterol; Drug: Placebo to QVA149

Interventions

QVA149 DRUG

QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler

QVA149 plus placebo to tiotropium and placebo to formoterol

Placebo to tiotropium DRUG

Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules

QVA149 plus placebo to tiotropium and placebo to formoterol

Placebo to formoterol DRUG

Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.

QVA149 plus placebo to tiotropium and placebo to formoterol

Tiotropium DRUG

Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.

Tiotropium plus Formoterol and placebo to QVA149

Formoterol DRUG

Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.

Tiotropium plus Formoterol and placebo to QVA149

Placebo to QVA149 DRUG

Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules

Tiotropium plus Formoterol and placebo to QVA149

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults aged ≥ 40 yrs
• Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
• Smoking history of at least 10 pack years
• Post-bronchodilator FEV1 \< 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

You may not qualify if:

• Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
• Patients with a history of long QT syndrome
• Patients with Type I or uncontrolled Type II diabetes
• Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
• Patients with any history of asthma
• Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
• Patients with concomitant pulmonary disease
• Patients requiring long term oxygen therapy (\>15 h a day)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (144)

Novartis Investigative Site

Berlin, Germany, 10969, Germany

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Novartis Investigative Site

Berlin, Germany, 12099, Germany

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Novartis Investigative Site

Berlin, Germany, 14050, Germany

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Novartis Investigative Site

Dresden, Germany, 01307, Germany

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Novartis Investigative Site

Heidelberg, Germany, 69117, Germany

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Novartis Investigative Site

Leipzig, Germany, 04207, Germany

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Novartis Investigative Site

Mainz, Germany, 55131, Germany

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Novartis Investigative Site

Marburg, Germany, 35037, Germany

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Novartis Investigative Site

Potsdam, Germany, 14467, Germany

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Novartis Investigative Site

Teterow, Germany, 17166, Germany

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Novartis Investigative Site

Koblenz, North Rhine-Westphalia, 56068, Germany

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Novartis Investigative Site

Cottbus, Saxony, 03050, Germany

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Aschaffenburg, 63739, Germany

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Augsburg, 86156, Germany

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Bad Neustadt an der Saale, 97616, Germany

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Bad Wörishofen, 86825, Germany

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Bamberg, 96049, Germany

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Bensheim, 64625, Germany

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Bergisch Gladbach, 51429, Germany

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Novartis Investigative Site

Berlin, 10115, Germany

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Novartis Investigative Site

Berlin, 10367, Germany

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Novartis Investigative Site

Berlin, 10717, Germany

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Novartis Investigative Site

Berlin, 10789, Germany

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Novartis Investigative Site

Berlin, 12043, Germany

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Novartis Investigative Site

Berlin, 12165, Germany

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Novartis Investigative Site

Berlin, 12203, Germany

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Novartis Investigative Site

Berlin, 12687, Germany

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Novartis Investigative Site

Berlin, 13057, Germany

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Novartis Investigative Site

Berlin, 13086, Germany

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Novartis Investigative Site

Berlin, 13156, Germany

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Novartis Investigative Site

Berlin, 13465, Germany

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Novartis Investigative Site

Berlin, 13507, Germany

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Novartis Investigative Site

Berlin, 14059, Germany

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Novartis Investigative Site

Bielefeld, 33617, Germany

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Bochum, 44787, Germany

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Bonn, 53119, Germany

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Bonn, 53123, Germany

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Borna, 04552, Germany

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Chemnitz, 09130, Germany

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Cologne, 51069, Germany

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Novartis Investigative Site

Cologne, 51605, Germany

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Novartis Investigative Site

Delitzsch, 04509, Germany

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Novartis Investigative Site

Donaustauf, 93093, Germany

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Dortmund, 44135, Germany

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Novartis Investigative Site

Dresden, 01069, Germany

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Novartis Investigative Site

Duisburg, 47057, Germany

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Novartis Investigative Site

Düren, 52349, Germany

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Düsseldorf, 40489, Germany

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Novartis Investigative Site

Eggenfelden, 84307, Germany

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Eisenach, 99817, Germany

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Erlangen, 91052, Germany

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Eschwege, 37269, Germany

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Essen, 45138, Germany

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Novartis Investigative Site

Essen, 45276, Germany

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Euskirchen, 53879, Germany

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Forchheim, 91301, Germany

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Frankfurt, 60389, Germany

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Novartis Investigative Site

Frankfurt, 60596, Germany

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Novartis Investigative Site

Fulda, 36039, Germany

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Novartis Investigative Site

Gauting, 82131, Germany

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Novartis Investigative Site

Geesthacht, 22502, Germany

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Gelnhausen, 63571, Germany

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Gelsenkirchen, 45879, Germany

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Göttingen, 37075, Germany

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Großhansdorf, 22947, Germany

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Gummersbach, 51643, Germany

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Güstrow, 18273, Germany

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Hagen, 59065, Germany

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Halberstadt, 38820, Germany

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Halle, 06108, Germany

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Hamburg, 20354, Germany

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Hamburg, 20357, Germany

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Novartis Investigative Site

Hamburg, 22299, Germany

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Novartis Investigative Site

Hamburg, 22527, Germany

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Novartis Investigative Site

Hannover Münden, 34346, Germany

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Hanover, 30163, Germany

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Hanover, 30317, Germany

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Novartis Investigative Site

Hanover, 30419, Germany

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Heidelberg, 69115, Germany

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Novartis Investigative Site

Hettstedt, 06333, Germany

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Hildesheim, 31134, Germany

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Novartis Investigative Site

Höchstadt an der Aisch, 91315, Germany

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Novartis Investigative Site

Kamen, 59174, Germany

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Kamenz, 01917, Germany

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Novartis Investigative Site

Kassel, 34121, Germany

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Krefeld, 47798, Germany

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Novartis Investigative Site

Landsberg, 86899, Germany

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Leipzig, 04103, Germany

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Novartis Investigative Site

Leipzig, 04275, Germany

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Novartis Investigative Site

Leipzig, 04357, Germany

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Novartis Investigative Site

Lübeck, 23558, Germany

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Novartis Investigative Site

Lüdenscheid, 58507, Germany

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Novartis Investigative Site

Mainz, 55116, Germany

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Mannheim, 68165, Germany

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Novartis Investigative Site

Marburg, 35037, Germany

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Novartis Investigative Site

Menden, 58706, Germany

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Novartis Investigative Site

Minden, 32423, Germany

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München, 80335, Germany

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Novartis Investigative Site

München, 80539, Germany

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Novartis Investigative Site

München, 81677, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Münster, 48147, Germany

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Novartis Investigative Site

Neu-Isenburg, 63263, Germany

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Novartis Investigative Site

Neu-Ulm, 89231, Germany

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Novartis Investigative Site

Neumünster, 24534, Germany

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Neunkirchen, 66539, Germany

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Neuruppin, 16816, Germany

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Neuss, 41462, Germany

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Oranienburg, 16515, Germany

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Novartis Investigative Site

Oschatz, 04758, Germany

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Oschersleben, 39387, Germany

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Novartis Investigative Site

Osnabrück, 49074, Germany

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Novartis Investigative Site

Peine, 31224, Germany

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Novartis Investigative Site

Potsdam, 14469, Germany

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Novartis Investigative Site

Potsdam, 14478, Germany

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Novartis Investigative Site

Prien A. Chiemsee, 83209, Germany

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Radebeul, 01445, Germany

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Rathenow, 14712, Germany

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Ratingen, 40878, Germany

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Reinfeld, 23858, Germany

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Rheine, 48431, Germany

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Novartis Investigative Site

Roth, 91154, Germany

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Rüdersdorf, 15562, Germany

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Novartis Investigative Site

Rüsselsheim am Main, 65428, Germany

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Saarbrücken, 66111, Germany

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Saarlouis, 66740, Germany

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Schleswig, 24837, Germany

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Schwabach, 91126, Germany

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Siegen, 57072, Germany

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Singen, 76224, Germany

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Novartis Investigative Site

Solingen, 42651, Germany

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Novartis Investigative Site

Solingen, 42665, Germany

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Sonneberg, 96515, Germany

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Novartis Investigative Site

Stade, 21680, Germany

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Novartis Investigative Site

Teuchern, 06682, Germany

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Ulm, 89073, Germany

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Novartis Investigative Site

Vöhringen, 89269, Germany

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Novartis Investigative Site

Wedel, 22880, Germany

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Weyhe, 28844, Germany

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Novartis Investigative Site

Wiesloch, 69168, Germany

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Novartis Investigative Site

Wissen, 57537, Germany

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Witten, 58452, Germany

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Novartis Investigative Site

Wuppertal, 42117, Germany

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Novartis Investigative Site

Zerbst, 39261, Germany

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Tiotropium Bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharnaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 22, 2014
• Results First Posted: April 29, 2014

Record last verified: 2014-05

Locations

DE (144)