Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)

NCT01555138 | Completed Phase 4 Results

• 2 other identifiers: CQAB149B24012011-003732-31
• Study Type: interventional
• Target: 581
• Locations: 9 countries
• Sites: 94

Brief Summary

The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Indacaterol; Salmeterol/fluticasone propionate

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons

  Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.

  12 weeks

Secondary Outcomes (10)

• Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons

  26 weeks

• FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons

  12 weeks

• FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons

  26 weeks

• FVC Over 26 Weeks of Treatment

  12 and 26 weeks

• Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison

  12 and 26 weeks

Study Arms (2)

Indacaterol

EXPERIMENTAL

Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)

Drug: Indacaterol

Salmeterol/fluticasone propionate

ACTIVE COMPARATOR

Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)

Drug: Salmeterol

Interventions

Indacaterol DRUG

Indacaterol is delivered via a SDDPI.

Indacaterol

Salmeterol DRUG

Salmeterol/fluticasone is delivered via a MDDPI

Salmeterol/fluticasone propionate

Eligibility Criteria

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

You may qualify if:

• Patients with moderate COPD (Stage II)
• Able to perform spirometry assessments
• Current or ex-smokers
• On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.

You may not qualify if:

• Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
• Having a history of, or current ECG abnormality
• Asthma

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (94)

Novartis Investigative Site

Caba, Argentina, C1119ACN, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, 1425, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, B6500EZL, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, C1120AAC, Argentina

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Novartis Investigative Site

Buenos Aires, Buenos Aires, C1125ABE, Argentina

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Novartis Investigative Site

C A B A, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, 1028, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, 1122, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, 1209, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, 1425, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, B8000XAV, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1056ABJ, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1122AAK, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1280AEB, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1414AIF, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1425DQI, Argentina

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Novartis Investigative Site

La Plata, Buenos Aires, 1900, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, B7600DHK, Argentina

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Novartis Investigative Site

Quilmes, Buenos Aires, B1878FNR, Argentina

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Novartis Investigative Site

Córdoba, Córdoba Province, X5016KEH, Argentina

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Novartis Investigative Site

Villa María, Córdoba Province, X5900JKA, Argentina

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Novartis Investigative Site

Concepción del Uruguay, Entre Ríos Province, 3260, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, 5500, Argentina

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Novartis Investigative Site

Mendoza, Mendoza Province, M5500CBA, Argentina

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Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

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Novartis Investigative Site

Salta, Salta Province, 4000, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, S2000CXH, Argentina

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Novartis Investigative Site

Santa Fe, Santa Fe Province, S3000FIL, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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Novartis Investigative Site

Buenos Aires, C1440BRR, Argentina

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Novartis Investigative Site

Bogota, Cundinamarca, Colombia

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Novartis Investigative Site

Barranquilla, Colombia

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Novartis Investigative Site

Bogotá, Colombia

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Novartis Investigative Site

Acquaviva delle Fonti, BA, 70021, Italy

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Novartis Investigative Site

Cassano delle Murge, BA, 70020, Italy

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Novartis Investigative Site

Treviglio, BG, 24047, Italy

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Caserta, CE, 81100, Italy

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Novartis Investigative Site

Forlì, FC, 47100, Italy

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Novartis Investigative Site

Cona, FE, 44100, Italy

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Novartis Investigative Site

Foggia, FG, 71100, Italy

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Novartis Investigative Site

Cassino, FR, 03043, Italy

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Novartis Investigative Site

Genova, GE, 16132, Italy

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Novartis Investigative Site

Messina, ME, 98158, Italy

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Novartis Investigative Site

Milan, MI, 20123, Italy

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Novartis Investigative Site

Milan, MI, 20126, Italy

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Novartis Investigative Site

Milan, MI, 20142, Italy

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Novartis Investigative Site

Sesto San Giovanni, Mi, 20099, Italy

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Novartis Investigative Site

Cittadella, PD, 35013, Italy

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Novartis Investigative Site

Pisa, PI, 56124, Italy

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Novartis Investigative Site

Pordenone, PN, 33170, Italy

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Novartis Investigative Site

Parma, PR, 43100, Italy

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Novartis Investigative Site

Pavia, PV, 27100, Italy

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Novartis Investigative Site

Salerno, SA, 84131, Italy

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Novartis Investigative Site

Cuasso al Monte, VA, 21050, Italy

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Novartis Investigative Site

Tradate, VA, 21049, Italy

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Novartis Investigative Site

Negrar, VR, 37024, Italy

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Novartis Investigative Site

Verona, VR, 37126, Italy

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Novartis Investigative Site

Wilayah Persekutuan, Kuala Lumpur, 50590, Malaysia

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Novartis Investigative Site

Kuching, Sarawak, 93586, Malaysia

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Novartis Investigative Site

Pulau Pinang, 10990, Malaysia

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Novartis Investigative Site

Guadalajara, Jalisco, 44100, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 11950, Mexico

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Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

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Novartis Investigative Site

Monterrey, Nuevo León, 64718, Mexico

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Novartis Investigative Site

Querétaro City, Querétaro, 76000, Mexico

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Novartis Investigative Site

San Luis Potosí City, San Luis Potosí, 78200, Mexico

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Novartis Investigative Site

Breda, Netherlands, 4819 EV, Netherlands

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Novartis Investigative Site

Helmond, Netherlands, 5707 HA, Netherlands

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Novartis Investigative Site

Rotterdam, 3045 PM, Netherlands

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Novartis Investigative Site

Loja, Andalusia, 18300, Spain

Location

Novartis Investigative Site

Sanlúcar de Barrameda, Andalusia, 11540, Spain

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Novartis Investigative Site

Valladolid, Castille and León, 47011, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08024, Spain

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Novartis Investigative Site

Canet de Mar, Catalonia, 08360, Spain

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Novartis Investigative Site

Corbera de Llobregat, Catalonia, 08757, Spain

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Novartis Investigative Site

Lleida, Catalonia, 25198, Spain

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Novartis Investigative Site

Madrid, Madrid, 28029, Spain

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Novartis Investigative Site

Pozuelo de Alarcón, Madrid, 28223, Spain

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Novartis Investigative Site

Muenchenstein, Switzerland, 4241, Switzerland

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Novartis Investigative Site

Basel, 4031, Switzerland

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Novartis Investigative Site

Biel, 2500, Switzerland

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Novartis Investigative Site

Gossau, 9200, Switzerland

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Novartis Investigative Site

Newcastle upon Tyne, Newcastle-upon-Tyne, NE7 7DN, United Kingdom

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Novartis Investigative Site

Dundee, Perthshire, DD1 2BU, United Kingdom

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Novartis Investigative Site

Hants, Southampton, SO9 5NY, United Kingdom

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Novartis Investigative Site

Bradford, BD9 6RJ, United Kingdom

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Novartis Investigative Site

Chester, CH2 1UL, United Kingdom

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Novartis Investigative Site

East Yorkshire, HU16 5JQ, United Kingdom

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Novartis Investigative Site

Kettering, NN16 8UZ, United Kingdom

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Novartis Investigative Site

Lancaster, LA1 4RP, United Kingdom

Location

Novartis Investigative Site

Surrey, KT16 0PZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Salmeterol Xinafoate

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)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 28, 2015
• Results First Posted: April 28, 2015

Record last verified: 2015-04

Locations

MY (3); NL (3); IT (25); ES (9); AR (32); CH (4); GB (9); CO (3); ME (6)