Study to evaluate the efficacy and safety of glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed - dose combination regarding symptoms and health status in patients with moderate COPD switching from treatment with any standard COPD regime

Phase 1

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003127-11-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-20
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4470

Inclusion Criteria

1. Patients who have signed an Informed Consent Form before any assessment is performed.

2. Male and female adults aged = 40 years.

3. Patients with moderate COPD according to the GOLD criteria 2013.

4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years. An ex-smoker is defined as a subject who has not smoked for = 6 months at Visit 1.)

5. Patients with airflow limitation indicated by a post-bronchodilator FEV1 =50% and =80%
of the predicted normal value and a post-bronchodilator FEV1/FVC <0.7 at Visit 1 or Visit
2 or documented in the medical notes in the previous 3 months to Visit 2. Post-
bronchodilator refers to within 10-15 min of inhalation of 400 µg (4x100 µg) of salbutamol. (At Visit 1, only patients with no reversibility test in the previous 3 months will require it in this visit. At Visit 2, all patients included in the sub-population for the exploratory objective will need a reversibility test in this visit to be used as baseline. Rest of patients will not need it at Visit 2 because they will have a previous one at Visit 1 or performed before [within 3 months]. In case that patients cannot perform [if applicable for lack of history in the previous 3 months] the reversibility test at Visit 1 due to a wash-out period is required [see Appendix 5], the reversibility test will be performed at Visit 2).

6. Patients who, at Visit 1, have been for at least 3 months on a stable dose of one of the following COPD baseline tratments:
- Any SABA monotherapy (such as, but not limited to, salbutamol),
- Any SAMA monotherapy (such as, but not limited to, ipratropium),
- Any SABA and SAMA in free or FDC (such as, but not limited to, salbutamol/ipratropium),
- Any LABA monotherapy (such as, but not limited to, formoterol, salmeterol, indacaterol),
- Any LAMA monotherapy (such as, but not limited to, tiotropium, aclidinium) except glycopyrronium bromide (NVA237),
- Any LABA and ICS in free (ICS such as, but not limited to, beclomethasone, fluticasone) or FDC (such as, but not limited to, salmeterol/fluticasone, formoterol/budesonide).
The exact list of therapies (either active ingredients or FDC) will depend on the available therapies on the market in the participating countries.

7. Patients with an mMRC score =1 at Visit 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1341
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3129

Exclusion Criteria

1. Pts with condit. contraind.. for treatm. with, or having a history of reactions/ hypersensit. to any of the following inhal. drugs or to drugs of similar chem. classes or any comp. thereof:
•Anti-cholinergic agents
•Long- and short-acting ß2-adrenergic agonists
•Sympathomimetic amines
•Lactose or any of the other excipients of the trial medication.

2. Pts with narr.-angle glaucoma or urin. retent., severe ren. impairm. (hist. of estim. glom. filtr. rate below 30 ml/min/1.73 m2 within 12 mo prior to V1), incl. those with end-stage ren. dis. requir. dialysis.

3. Pts with active/ clin. hist. of asthma. If the Investig. finds clear and compelling evid. that a pt was misdiagnosed with asthma in the past, the burden of proof is on the Investig. to properly document this prev. misdiagnosis. This doc. must incl. the rationale for this change in diagn. incl. ref. to the differential diagn. that supports this decision.

4. Pts with a hist. of malign. of any organ syst. (other than local. basal cell carcin. of the skin), treat. or untreat., within the past 5 y, regardless of whether there is evid. of local recurr. or metastases.

5. Pts who have a post-bronchodilat. FEV1 decrease more than 10% compared to pre-bronchodilat. FEV1 result at Visit 2.

6. A doc. history of >1 COPD exacerb. requiring treatm. with syst. corticosteroids or atb and/or hospital. in the prev. 12 mo. Pts who haven´t had a COPD exacerb. in the prev. 12 mo and develop a COPD exacerb. between screening (V1) and baseline (V2) will not be eligible but will
be permitted to be re-screen. after a min. of 6 wks after the resolut. of the COPD exacerb. (Pts suffer. an exacerb. between V1 and V2 can only be re-screen. in case it is the first one in the prev. 12 mo). In case this COPD exacerb. has let to an alteration of the pt COPD treatm., before this pt can be re-screen. 3 mo of stable COPD treatm. will be required as describ. in Incl. Crit. 6).

7. Pts who, in the judgm. of the investig., have a clin. relev. lab. abnorm. or a clin. signif. cond. such as (but not limited to):
• Unstable ischem. heart dis., left ventric. failure (NYHA Class III & IV), hist. of myoc. infarct., arrhythmia (excl. chron. stable atrial fibrill.). Pts with such events not consid. clin. signif. by the investig. may be consid. for inclus. in the study
• Uncontr. hypo-or hyperthyroidism, hypokalaemia or hyperadrenergic state
• Any cond. which might comprom. pt safety or compl., interfere with eval., or preclude complet. of the study

8. History of resting QTcF (Fridericia pref., but Bazett accept.)
>450 msec (male) or
>460 msec (female) within 5y before V1.

9. Pts who are treat. with glyc. bromide (NVA237) at V1 aren´t allowed to be incl. into the trial.

10. Pts receiv. any other prohib. COPD-relat. med. specif. in Table 5-2. Prohib. COPD-rel. med. must undergo the requir. wash-out per. prior to V2.

11. Use of other inv. drugs within 5 half-lives of enroll. or within 30 days, whichever is longer.

12. Pregn. or nurs. women, where pregn. is def. as the state of a female after concept. and until the termin. of gest., conf. by a posit. hCG lab. test.

13. Women of child-bear. pot., def. as all women physiol. capable of bec. preg., unless they are using effect. methods of contrac. during dosing of study treatm. Effect. contrac. methods incl.:
• Total abst. (when this is in line with the pref. and usual lifestyle of the subject. Periodic abst. (e.g., ca

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified